Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

• Review the pathophysiology and prognosis of hormone receptor (HR)-positive, HER2-positive breast cancer, and understand the implications for therapeutic decision-making.
• Appraise available clinical research data, current guideline recommendations and expert best practices to guide the selection of first-line and maintenance therapy for patients with newly diagnosed HR-positive, HER2-positive metastatic breast cancer (mBC).
• Assess recently published Phase III data with HER2-directed antibody-drug conjugate therapy as a component of first-line therapy, and consider the current role of this novel strategy in treatment for patients with HR-positive, HER2-positive mBC.
• Appreciate the biological rationale for and available research findings with CDK4/6 inhibition in combination with endocrine and anti-HER2 maintenance therapy for patients with HR-positive, HER2-positive mBC, and use this information to personalize treatment recommendations.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Proceedings: Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation components and a post-test, enables the participant to earn up to 1.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/FirstLineTherapyHER2mBC26/1/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Virginia F Borges, MD, MMSc
Professor of Medicine with Tenure
Robert F and Patricia Young Connor Endowed Chair in Young Women’s Breast Cancer Research
Deputy Division Head, Medical Oncology
Co-Director, Diane O’Connor Thompson Breast Center
Co-Director, Breast Cancer Research Program
Director, Young Women’s Breast Cancer Translational Program
University of Colorado Anschutz Medical Campus
Aurora, Colorado

Advisory Committees: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Pfizer Inc; Consulting Agreements: Gilead Sciences Inc, Olema Oncology, Pfizer Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Merck, Olema Oncology, Pfizer Inc.

Ian E Krop, MD, PhD
Associate Cancer Center Director for Clinical Research
Medical Director, Clinical Trials Office
Yale Cancer Center
Chief Scientific Officer
Translational Breast Cancer Research Consortium
New Haven, Connecticut

Advisory Committees: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Genentech, a member of the Roche Group, Lilly, Seagen Inc; Consulting Agreements: ALX Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Halda Therapeutics, Novartis; Contracted Research: Pfizer Inc; Data and Safety Monitoring Boards/Committees: Novartis, Seagen Inc.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from Pfizer Inc.

Release date: April 2026
Expiration date: April 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Bischoff H, Petit T. CDK4/6 inhibitors in HER2-positive metastatic breast cancer. Clin Breast Cancer 2026;26(2):93-104. Abstract

Dieras V et al. HER2CLIMB-05: A phase III study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as first-line maintenance therapy for HER2+ metastatic breast cancer. J Clin Oncol 2025;[Online ahead of print]. Abstract

Hamilton EP et al. HER2CLIMB-05: Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer. ASCO 2023;Abstract TPS1115.

Kuemmel S et al. heredERA Breast Cancer: A phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer. BMC Cancer 2024;24(1):641. Abstract

Loibl S et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC): Additional analyses of DESTINY-Breast09 in key subgroups of interest. ESMO 2025;Abstract LBA18.

Metzger O et al. Palbociclib for hormone-receptor-positive, HER2-positive advanced breast cancer. N Engl J Med 2026;394(5):451-62. Abstract

Metzger O et al. Central nervous system outcomes from the phase III PATINA trial (AFT-38). San Antonio Breast Cancer Symposium 2025;Abstract RF4-01.

Swain SM et al. INAVO122: A phase III study of maintenance inavolisib or placebo + pertuzumab + trastuzumab following induction with pertuzumab + trastuzumab + a taxane in patients (pts) with PIK3CA-mutated, HER2-positive advanced breast cancer (HER2+ aBC). ASCO 2024;Abstract TPS1124.

Swain SM et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 2015;372(8):724-34. Abstract

Tolaney SM et al. Trastuzumab deruxtecan plus pertuzumab for HER2-positive metastatic breast cancer. N Engl J Med 2025;[Online ahead of print]. Abstract

Tolaney SM et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025;Abstract LBA1008.

Vaz-Luis IV et al. Health-related quality of life (HRQoL) from the PATINA trial (AFT-38): Impact of adding palbociclib to HER2 and endocrine therapy (ET) after induction in HR+/HER2+ metastatic breast cancer (MBC). ESMO 2025;Abstract 485MO.

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of metastatic urothelial bladder cancer.

LEARNING OBJECTIVES

• Review how biological factors and patient characteristics such as age, performance status, prior treatment, comorbidities and preexisting conditions influence the selection and sequencing of treatment for metastatic urothelial bladder cancer (mUBC).
• Recognize the incidence of nectin-4 expression in patients with UBC, and appreciate the scientific justification for the development of antibody-drug conjugates (ADCs) targeting this novel biomarker.
• Interrogate published efficacy and safety findings with anti-PD-1/PD-L1 antibodies in combination with ADC therapy as first-line treatment for mUBC, and consider the current role of this strategy in patient care.
• Recall pivotal clinical trial findings leading to the FDA approval of novel compounds with unique mechanisms of action for previously treated locally advanced or metastatic UBC, such as ADCs and tyrosine kinase inhibitors, and identify patients for whom these approaches would be appropriate.
• Appreciate the frequency and severity of therapy-related adverse events commonly encountered by patients receiving guideline-endorsed agents and regimens for mUBC, and enact effective monitoring and management procedures.
• Describe the scientific justification for and published research data with novel strategies under investigation in UBC, and effectively prioritize clinical trial opportunities for eligible patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.75 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/RapidCaseReview2026/Bladder/2/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY

Fern Anari, MD
Assistant Professor of Genitourinary Medical Oncology
Fox Chase Cancer Center
Philadelphia, Pennsylvania

Catherine Fahey, MD, PhD
Assistant Professor, Division of Oncology
Department of Medicine
Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina

The following faculty reported relevant financial relationships with ineligible entities:

Matthew D Galsky, MD
Lillian and Howard Stratton Professor of Medicine
Icahn School of Medicine at Mount Sinai
Co-Leader, Bladder Cancer Center of Excellence
Associate Director, Translational Research
The Tisch Cancer Institute
New York, New York

Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, EMD Serono Inc, Gilead Sciences Inc, Janssen Biotech Inc, Merck, Pfizer Inc, Seagen Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from Astellas and Pfizer Inc.

Release date: February 2026
Expiration date: February 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

De Santis M et al. Durvalumab (D) in combination with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Galsky MD et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O. 

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P.

Necchi A et al. Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results. ESMO 2025;Abstract LBA112.

Powles TB et al. IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. ESMO 2025;Abstract LBA8.

Rha SY et al. Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase II TROPION-PanTumor03 study. ESMO 2025;Abstract 3072MO.

Sheng X et al. Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression. ESMO 2025;Abstract LBA7.

van der Heijden MS et al. Health-related quality of life (HRQoL) outcomes from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC). ESMO 2025;Abstract 3069MO.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of gastrointestinal cancers.

LEARNING OBJECTIVES

• Understand the clinical relevance of microsatellite instability (MSI)/mismatch repair (MMR) deficiency in patients with localized colorectal cancer (CRC), and consider the implications for clinical care.
• Evaluate the biological rationale for the use of immune checkpoint inhibitors in the care of patients with localized MSI-high/MMR-deficient CRC, and provide counsel regarding available clinical evidence and guideline-endorsed treatment recommendations.
• Optimize the current and future use of neoadjuvant therapy for patients with localized and locally advanced CRC, considering the influence of various clinical and biological factors, including MSI/MMR status.
• Recognize the clinical relevance of circulating tumor DNA as a prognostic and predictive biomarker in CRC, and comprehend the rationale for its use in detecting molecular residual disease in patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up 0.5 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Program: ResearchToPractice.com/ASCOGI26/LocalizedCRC/Micro/1/Video and evaluation ResearchToPractice.com/ASCOGI26/LocalizedCRC/Micro/1/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Stacey A Cohen, MD
Professor
Fred Hutchinson Cancer Center
University of Washington
Seattle, Washington

Advisory Committees: AbbVie Inc, Agenus Inc, Caris Life Sciences, DoMore Diagnostics, Exact Sciences Corporation, Guardant Health, Incyte Corporation, Janssen Biotech Inc, Merck, Pfizer Inc, Roche Laboratories Inc; Data and Safety Monitoring Boards/Committees: GSK.

Jenny Seligmann, MBChB, PhD
Professor of Gastrointestinal Cancer
University of Leeds
Leeds, United Kingdom

No relevant financial relationships to disclose.

MODERATOR
Christopher Lieu, MD
Professor of Medicine
Associate Director for Clinical Research
Director, GI Medical Oncology
University of Colorado Cancer Center
Aurora, Colorado

Consulting Agreements (to Institution): Pfizer Inc; Contracted Research (All to Institution): Genentech, a member of the Roche Group, Janssen Biotech Inc, Sanofi.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Genentech, a member of the Roche Group, GSK, and Natera Inc. 

Release date: March 2026
Expiration date: March 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Seligmann

André T et al. Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): A randomised, open-label, phase 3 trial. Lancet 2025;405(10476):383-95. Abstract

Cercek A et al. A phase two, single-arm, open-label study with dostarlimab monotherapy in participants with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (AZUR-1). Clin Colorectal Cancer 2025;24(2):325-30. Abstract

Cercek A et al. Nonoperative management of mismatch repair-deficient tumors. N Engl J Med 2025;392(23):2297-308. Abstract

Chalabi M et al. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med 2020;26(4):566-76. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Morton D et al. Preoperative chemotherapy for operable colon cancer: Mature results of an international randomized controlled trial. J Clin Oncol 2023;41(8):1541-52. Abstract

Ochiai K et al. Total neoadjuvant therapy for rectal cancer: Which regimens to use? Cancers (Basel) 2024;16(11):2093. Abstract

Sassun R et al. Oncological outcomes of neoadjuvant chemotherapy versus upfront surgery in locally advanced colon cancer: A systematic review, meta-analysis, and sequential analysis. Ann Surg Oncol 2025;32(9):6720-7. Abstract

Seligmann J et al. Comparison of outcomes in clinical trials of locally advanced dMMR colon cancer: FOxTROT and NICHE-2. ESMO 2025;Abstract 724O.

Dr Lieu

André T et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2009;27(19):3109-16. Abstract

Courneya KS et al. Structured exercise after adjuvant chemotherapy for colon cancer. N Engl J Med 2025;393(1):13-25. Abstract

Martling A et al. Low-dose aspirin for PI3K-altered localized colorectal cancer. N Engl J Med 2025;393(11):1051-64. Abstract

Rasschaert G et al. AZUR-4, a phase 2, open label, randomized study of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer. ASCO 2025;Abstract TPS3649.

Sargent DJ et al. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol 2010;28(20):3219-26. Abstract

Sinicrope FA et al. Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC). ASCO 2025;Abstract LBA1.

Dr Cohen

Bando H et al. A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): The ALTAIR study. Gastrointestinal Cancers Symposium 2025;Abstract LBA22.

Cohen SA et al. Practical recommendations for using ctDNA in clinical decision making. Nature 2023;619(7969):259-68. Abstract

Dasari A et al. Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA): NRG-GI008. ASCO 2025;Abstract TPS3644.

Dasari A et al. Subgroup analyses of safety and efficacy by number and types of prior lines of treatment in FRESCO-2, a global phase III study of fruquintinib in patients with refractory metastatic colorectal cancer. ASCO 2023;Abstract 3604.

Dasari A et al. ctDNA applications and integration in colorectal cancer: An NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol 2020;17(12):757-70. Abstract

Gianni C et al. Cell-free DNA fragmentomics: A promising biomarker for diagnosis, prognosis and prediction of response in breast cancer. Int J Mol Sci 2022;23(22):14197. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Kotaka M et al. Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan. Gastrointestinal Cancers Symposium 2022;Abstract 9.

Maddalena G et al. INTERCEPT Program of circulating tumor DNA (ctDNA) testing for minimal residual disease (MRD) in colorectal cancer (CRC): Results from a prospective clinical cohort. Gastrointestinal Cancers Symposium 2024;Abstract 27.

Morris VK et al. Phase II results of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) phase II/III study. Gastrointestinal Cancers Symposium 2024;Abstract 5.

Nakamura Y et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nat Med 2024;30(11):3272-83. Abstract

Nowak JA et al. Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702. Gastrointestinal Cancers Symposium 2025;Abstract LBA14.

Parikh AR et al. Minimal residual disease detection using a plasma-only circulating tumor DNA assay in patients with colorectal cancer. Clin Cancer Res 2021;27(20):5586-94. Abstract

Rocha Lima CMSP et al. Colorectal Cancer Metastatic dMMR Immunotherapy (COMMIT) study: A randomized phase III study of atezolizumab (atezo) monotherapy versus mFOLFOX6/bevacizumab/atezo (FFX/bev) in the first-line treatment of patients (pts) with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) — NRG-GI004/SWOG-S1610. ASCO 2026;Abstract 14.

Rolfo C, Russo A. Liquid biopsy for early stage lung cancer moves ever closer. Nat Rev Clin Oncol 2020;17(9):523-4. Abstract

Shah PK et al. Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort. Gastrointestinal Cancers Symposium 2025;Abstract 15.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: 5-year outcomes of the randomized DYNAMIC trial. Nat Med 2025;31(5):1509-18. Abstract

Tie J et al. Circulating tumor DNA-guided adjuvant therapy in locally advanced colon cancer: The randomized phase 2/3 DYNAMIC-III trial. Nat Med 2025;31(12):4291-300. Abstract

Tie J et al. ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG). ASCO 2025;Abstract 3503.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: Overall survival and updated 5-year results from the randomized DYNAMIC trial. ASCO 2024;Abstract 108.

Zhang GQ et al. Predictive role of circulating tumor DNA in stage III colon cancer treated with celecoxib: A post hoc analysis of the CALG

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of gastrointestinal (GI) cancers.

LEARNING OBJECTIVES

• Appreciate the prevalence and clinical relevance of human epidermal growth factor receptor 2 (HER2) amplification or overexpression in various GI cancers, and consider the implications for biomarker assessment and clinical management.
• Evaluate published clinical trial findings with HER2-directed therapies for HER2-positive biliary tract cancers, and optimally incorporate available agents into the clinical care of appropriately selected patients.
• Review published and emerging research findings with HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current and future role of various agents and regimens.
• Recall available data with HER2-targeted agents and strategies for patients with previously treated HER2-overexpressing colorectal cancer, and optimally identify candidates who may be appropriate for these approaches.
• Appraise the side effects associated with HER2-directed therapies with established efficacy in GI cancers, and use this information to develop supportive management plans for patients.
• Recall the design of ongoing clinical trials evaluating novel HER2-directed strategies for HER2-positive GI cancers, and counsel appropriately selected patients about availability and participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Proceedings: Research To Practice designates this enduring material for a maximum of 1.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.75 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ASCOGI26/HER2PosGI/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Haley Ellis, MD
Medical Oncologist
Massachusetts General Hospital
Instructor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: AstraZeneca Pharmaceuticals LP, Cogent Biosciences, Jazz Pharmaceuticals Inc; Honoraria: Incyte Corporation, Jazz Pharmaceuticals Inc; Nonrelevant Financial Relationships: Medscape, OncLive, The Jackson Laboratory.

Eric Van Cutsem, MD, PhD
Professor of Medicine
Digestive Oncology
University Hospitals Leuven
Leuven, Belgium

Consulting Agreements: AbbVie Inc, Agenus Inc, ALX Oncology, Amgen Inc, Arcus Biosciences, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, BioNTech SE, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cantargia, Daiichi Sankyo Inc, Debiopharm, Eisai Inc, ElmediX, Fosun Pharma, Galapagos NV, GSK, Incyte Corporation, Ipsen Biopharmaceuticals Inc, iTeos Therapeutics, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck KGaA, Microbial Machines, Mirati Therapeutics Inc, MSD, Nordic Pharma, Novartis, Novocure Inc, Pfizer Inc, Pierre Fabre, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, Simcere, Taiho Oncology Inc, Takeda Pharmaceutical Company Limited, Trishula Therapeutics, Zymeworks Inc.

Zev Wainberg, MD, MSc
Co-Director, GI Oncology Program
Director of Early Phase Clinical Research
Jonsson Comprehensive Cancer Center
UCLA School of Medicine
Los Angeles, California

Consulting Agreements: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Gilead Sciences Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Novartis, Novocure Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Arcus Biosciences, Bristol Myers Squibb; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Pfizer Inc.

MODERATOR
Lionel A Kankeu Fonkoua, MD
Senior Associate Consultant
Assistant Professor of Oncology Division of Medical Oncology, GI Cancer Program
Mayo Clinic
Rochester, Minnesota

No relevant conflicts of interest to disclose.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc.

Release date: January 2026
Expiration date: January 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Ellis

Ayasun R et al. The role of HER2 status in the biliary tract cancers. Cancers (Basel) 2023;15(9):2628. Abstract

Bartley AN et al. HER2 testing and clinical decision making in gastroesophageal adenocarcinoma: Guideline from the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. J Clin Oncol 2017;35(4):446-44. Abstract

Harding JJ et al. Landmark analysis of overall survival (OS) by objective response in patients (pts) with previously treated, advanced HER2-positive biliary tract cancer (BTC): Post hoc analysis of the HERIZON-BTC-01 trial. Gastrointestinal Cancers Symposium 2026;Abstract 545.

Harding JJ et al. HERIZON-BTC-302: A phase 3 study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). Gastrointestinal Cancers Symposium 2025;Abstract TPS648.

Ikeda M et al. Randomized, open-label, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care (SOC) in first-line, human epidermal growth factor receptor 2 (HER2)-expressing, locally advanced or metastatic (LA/m) biliary tract cancer (BTC): DESTINY-BTC01. ESMO 2024;Abstract 261TiP.

Inoue K et al. Clinicomolecular profile and efficacy of human epidermal growth factor receptor 2 (HER2)-targeted therapy for HER2-amplified advanced biliary tract cancer. JCO Precis Oncol 2025:e2400718. Abstract

Kehmann L et al. Evolving therapeutic landscape of advanced biliary tract cancer: From chemotherapy to molecular targets. ESMO Open 2024;9(10):103706. Abstract

Lamarca A et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): A phase 3, open-label, randomised, controlled trial. Lancet Oncol 2021;22(5):690-701. Abstract

Lee C et al. Impact of HER2-positivity on prognosis and targeted therapeutic outcomes in advanced biliary tract cancer. Gastrointestinal Cancers Symposium 2025;Abstract 629.

Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract

Oh D-Y et al. Durvalumab plus chemotherapy in advanced biliary tract cancer: 3-year overall survival update from the phase III TOPAZ-1 study. J Hepatol 2025;83(5):1092-101. Abstract

Ohba A et al. Trastuzumab deruxtecan in human epidermal growth factor receptor 2–expressing biliary tract cancer (HERB; NCCH1805): A multicenter, single-arm, phase II trial. J Clin Oncol 2024;42(27):3207-17. Abstract

Pant S et al. Zanidatamab in HER2-positive metastatic biliary tract cancer: Final results from HERIZON-BTC-01. JAMA Oncol 2025;12(1):106-9. Abstract

Søreide K et al. Biliary tract cancer. Eur J Surg Oncol 2025;51(6):108489. Abstract

Dr Wainberg

Cammarota A et al. Targeting HER2 in gastroesophageal cancer: A new appetite for an old plight. Drugs 2025;85(3):361-83. Abstract

Elimova E et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. Gastrointestinal Cancer Symposium 2026;Abstract LBA285.

Elimova E et al. Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: Primary results of a multicentre, single-arm, phase 2 study. Lancet Oncol 2025;26(7):847-59. Abstract

Janjigian YY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO 2024;Abstract 1400O.

Janjigian YY et al. Trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients (pts) with advanced/metastatic HER2-positive (HER2+) esophageal, gastric or gastroesophageal junction adenocarcinoma (GEJA): DESTINY-Gastric03 (DG-03). ESMO 2024;Abstract 1401O.

Jubashi A et al. Prognostic and predictive factors for the efficacy and safety of trastuzumab deruxtecan in HER2-positive gastric or gastroesophageal junction cancer. Gastric Cancer 2025;28(1):63-73. Abstract

Klempner et al. ERBB2 copy number (CN) as a quantitative biomarker for real-world (RW) outcomes to anti-HER2 therapy in advanced gastroesophageal adenocarcinoma (adv GEA). ASCO 2021;Abstract 4045.

Shitara K et al. An open-label, randomized, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) + chemotherapy (chemo) ± pembrolizumab (pembro) versus chemo + trastuzumab ± pembro in first-line metastatic HER2+ gastric or gastroesophageal junction (GEJ) cancer: DESTINY-Gastric05. ASCO 2025;Abstract TPS4207.

Shitara K et al. Trastuzumab deruxtecan or ramucirumab plus paclitaxel in gastric cancer. N Engl J Med 2025;393(4):336-48. Abstract

Shitara K et al. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: Exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial. Nat Med 2024;30(7):1933-42. Abstract

Yamaguchi K et al. Trastuzumab deruxtecan in anti-human epidermal growth factor receptor 2 treatment-naive patients with human epidermal growth factor receptor 2-low gastric or gastroesophageal junction adenocarcinoma: Exploratory cohort results in a phase II trial. J Clin Oncol 2023;41(4):816-25. Abstract

Yang H et al. Oesophageal cancer. Lancet 2024;404(10466):1991-2005. Abstract

Prof Van Cutsem

Germani MM et al. Impact of human epidermal growth factor receptor 2 in patients with metastatic colorectal cancer treated with chemotherapy plus bevacizumab or anti-EGFRs: Exploratory analysis of eight randomized trials. J Clin Oncol 2025;43(29):3184-97. Abstract

Meric-Bernstam F et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: A phase 1, dose-escalation and expansion study. Lancet Oncol 2022;23(12):1558-70. Abstract

Oh D-Y, Bang Y-J. HER2-targeted therapies – A role beyond breast cancer. Nat Rev Clin Oncol 2020;17(1):33-48. Abstract

Raghav K et al. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): Primary results from a multicentre, randomised, phase 2 trial. Lancet Oncol 2024;25(9):1147-62. Abstract

Rha SY et al. Zanidatamab (Zani) + chemotherapy (CT) in first-line (1L) human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic colorectal cancer (mCRC). ESMO 2024;Abstract 516MO.

Sartore-Bianchi A et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): A proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol 2016;17(6):738-46. Abstract

Strickler JH et al. MOUNTAINEER-03 phase III study design: First-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer. Future Oncol 2025;21(3):303-11. Abstract

Strickler JH et al. Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER). ASCO 2024;Abstract 3509.

Vaghi C et al. Targeting HER2 in metastatic colorectal cancer: Current therapies, biomarker refinement, and emerging strategies. Drugs 2026;86(1):37-57. Abstract

Yoshino T et al. Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer. Nat Commun 2023;14(1):3332. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of gastrointestinal cancers.

LEARNING OBJECTIVES

• Understand the clinical relevance of microsatellite instability (MSI)/mismatch repair (MMR) deficiency in patients with localized colorectal cancer (CRC), and consider the implications for clinical care.
• Evaluate the biological rationale for the use of immune checkpoint inhibitors in the care of patients with localized MSI-high (MSI-H)/MMR-deficient (dMMR) CRC, and provide counsel regarding available clinical evidence and guideline-endorsed treatment recommendations.
• Appreciate published research documenting the efficacy and safety of anti-PD-1/PD-L1 antibody therapy added to standard adjuvant chemotherapy for Stage III MSI-H/dMMR colon cancer, and counsel patients regarding the potential role of this novel therapeutic approach.
• Recognize the clinical relevance of circulating tumor DNA as a prognostic and predictive biomarker in CRC, and comprehend the rationale for its use in detecting molecular residual disease in patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT

Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.5 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Program: ResearchToPractice.com/ASCOGI26/LocalizedCRC/Micro/2/Video and evaluation ResearchToPractice.com/ASCOGI26/LocalizedCRC/Micro/2/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Stacey A Cohen, MD
Professor
Fred Hutchinson Cancer Center
University of Washington
Seattle, Washington

Advisory Committees: AbbVie Inc, Agenus Inc, Caris Life Sciences, DoMore Diagnostics, Exact Sciences Corporation, Guardant Health, Incyte Corporation, Janssen Biotech Inc, Merck, Pfizer Inc, Roche Laboratories Inc; Data and Safety Monitoring Boards/Committees: GSK.

Jenny Seligmann, MBChB, PhD
Professor of Gastrointestinal Cancer
University of Leeds
Leeds, United Kingdom

No relevant financial relationships to disclose.

MODERATOR
Christopher Lieu, MD
Professor of Medicine
Associate Director for Clinical Research
Director, GI Medical Oncology
University of Colorado Cancer Center
Aurora, Colorado

Consulting Agreements (to Institution): Pfizer Inc; Contracted Research (All to Institution): Genentech, a member of the Roche Group, Janssen Biotech Inc, Sanofi.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Genentech, a member of the Roche Group, GSK, and Natera Inc. 

Release date: April 2026
Expiration date: April 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Seligmann

André T et al. Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): A randomised, open-label, phase 3 trial. Lancet 2025;405(10476):383-95. Abstract

Cercek A et al. A phase two, single-arm, open-label study with dostarlimab monotherapy in participants with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (AZUR-1). Clin Colorectal Cancer 2025;24(2):325-30. Abstract

Cercek A et al. Nonoperative management of mismatch repair-deficient tumors. N Engl J Med 2025;392(23):2297-308. Abstract

Chalabi M et al. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med 2020;26(4):566-76. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Morton D et al. Preoperative chemotherapy for operable colon cancer: Mature results of an international randomized controlled trial. J Clin Oncol 2023;41(8):1541-52. Abstract

Ochiai K et al. Total neoadjuvant therapy for rectal cancer: Which regimens to use? Cancers (Basel) 2024;16(11):2093. Abstract

Sassun R et al. Oncological outcomes of neoadjuvant chemotherapy versus upfront surgery in locally advanced colon cancer: A systematic review, meta-analysis, and sequential analysis. Ann Surg Oncol 2025;32(9):6720-7. Abstract

Seligmann J et al. Comparison of outcomes in clinical trials of locally advanced dMMR colon cancer: FOxTROT and NICHE-2. ESMO 2025;Abstract 724O.

Dr Lieu

André T et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2009;27(19):3109-16. Abstract

Courneya KS et al. Structured exercise after adjuvant chemotherapy for colon cancer. N Engl J Med 2025;393(1):13-25. Abstract

Martling A et al. Low-dose aspirin for PI3K-altered localized colorectal cancer. N Engl J Med 2025;393(11):1051-64. Abstract

Rasschaert G et al. AZUR-4, a phase 2, open label, randomized study of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer. ASCO 2025;Abstract TPS3649.

Sargent DJ et al. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol 2010;28(20):3219-26. Abstract

Sinicrope FA et al. Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC). ASCO 2025;Abstract LBA1.

Dr Cohen

Bando H et al. A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): The ALTAIR study. Gastrointestinal Cancers Symposium 2025;Abstract LBA22.

Cohen SA et al. Practical recommendations for using ctDNA in clinical decision making. Nature 2023;619(7969):259-68. Abstract

Dasari A et al. Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA): NRG-GI008. ASCO 2025;Abstract TPS3644.

Dasari A et al. Subgroup analyses of safety and efficacy by number and types of prior lines of treatment in FRESCO-2, a global phase III study of fruquintinib in patients with refractory metastatic colorectal cancer. ASCO 2023;Abstract 3604.

Dasari A et al. ctDNA applications and integration in colorectal cancer: An NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol 2020;17(12):757-70. Abstract

Gianni C et al. Cell-free DNA fragmentomics: A promising biomarker for diagnosis, prognosis and prediction of response in breast cancer. Int J Mol Sci 2022;23(22):14197. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Kotaka M et al. Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan. Gastrointestinal Cancers Symposium 2022;Abstract 9.

Maddalena G et al. INTERCEPT Program of circulating tumor DNA (ctDNA) testing for minimal residual disease (MRD) in colorectal cancer (CRC): Results from a prospective clinical cohort. Gastrointestinal Cancers Symposium 2024;Abstract 27.

Morris VK et al. Phase II results of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) phase II/III study. Gastrointestinal Cancers Symposium 2024;Abstract 5.

Nakamura Y et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nat Med 2024;30(11):3272-83. Abstract

Nowak JA et al. Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702. Gastrointestinal Cancers Symposium 2025;Abstract LBA14.

Parikh AR et al. Minimal residual disease detection using a plasma-only circulating tumor DNA assay in patients with colorectal cancer. Clin Cancer Res 2021;27(20):5586-94. Abstract

Rocha Lima CMSP et al. Colorectal Cancer Metastatic dMMR Immunotherapy (COMMIT) study: A randomized phase III study of atezolizumab (atezo) monotherapy versus mFOLFOX6/bevacizumab/atezo (FFX/bev) in the first-line treatment of patients (pts) with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) — NRG-GI004/SWOG-S1610. ASCO 2026;Abstract 14.

Rolfo C, Russo A. Liquid biopsy for early stage lung cancer moves ever closer. Nat Rev Clin Oncol 2020;17(9):523-4. Abstract

Shah PK et al. Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort. Gastrointestinal Cancers Symposium 2025;Abstract 15.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: 5-year outcomes of the randomized DYNAMIC trial. Nat Med 2025;31(5):1509-18. Abstract

Tie J et al. Circulating tumor DNA-guided adjuvant therapy in locally advanced colon cancer: The randomized phase 2/3 DYNAMIC-III trial. Nat Med 2025;31(12):4291-300. Abstract

Tie J et al. ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG). ASCO 2025;Abstract 3503.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: Overall survival and updated 5-year results from the randomized DYNAMIC trial. ASCO 2024;Abstract 108.

Zhang GQ et al. Predictive role of circulating tumor DNA in stage III colon cancer treated with celecoxib: A post hoc analysis of the CALG

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of gastrointestinal cancers.

LEARNING OBJECTIVES

• Appreciate the prevalence and clinical relevance of human epidermal growth factor receptor 2 (HER2) amplification or overexpression in various GI cancers, and consider the implications for biomarker assessment and clinical management.
• Evaluate published clinical trial findings with HER2-directed therapies for HER2-positive biliary tract cancers, and optimally incorporate available agents into the clinical care of appropriately selected patients.
• Appraise the side effects associated with HER2-directed therapies with established efficacy in GI cancers, and use this information to develop supportive management plans for patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Proceedings: Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Program: ResearchToPractice.com/ASCOGI26/HER2PosGI/Micro/1/Video and evaluation ResearchToPractice.com/ASCOGI26/HER2PosGI/Micro/1/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Haley Ellis, MD
Medical Oncologist
Massachusetts General Hospital
Instructor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: AstraZeneca Pharmaceuticals LP, Cogent Biosciences, Jazz Pharmaceuticals Inc; Honoraria: Incyte Corporation, Jazz Pharmaceuticals Inc; Nonrelevant Financial Relationships: Medscape, OncLive, The Jackson Laboratory.

Eric Van Cutsem, MD, PhD
Professor of Medicine
Digestive Oncology
University Hospitals Leuven
Leuven, Belgium

Consulting Agreements: AbbVie Inc, Agenus Inc, ALX Oncology, Amgen Inc, Arcus Biosciences, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, BioNTech SE, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cantargia, Daiichi Sankyo Inc, Debiopharm, Eisai Inc, ElmediX, Fosun Pharma, Galapagos NV, GSK, Incyte Corporation, Ipsen Biopharmaceuticals Inc, iTeos Therapeutics, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck KGaA, Microbial Machines, Mirati Therapeutics Inc, MSD, Nordic Pharma, Novartis, Novocure Inc, Pfizer Inc, Pierre Fabre, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, Simcere, Taiho Oncology Inc, Takeda Pharmaceutical Company Limited, Trishula Therapeutics, Zymeworks Inc.

Zev Wainberg, MD, MSc
Co-Director, GI Oncology Program
Director of Early Phase Clinical Research
Jonsson Comprehensive Cancer Center
UCLA School of Medicine
Los Angeles, California

Consulting Agreements: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Gilead Sciences Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Novartis, Novocure Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Arcus Biosciences, Bristol Myers Squibb; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Pfizer Inc.

MODERATOR
Lionel A Kankeu Fonkoua, MD
Senior Associate Consultant
Assistant Professor of Oncology Division of Medical Oncology, GI Cancer Program
Mayo Clinic
Rochester, Minnesota

No relevant financial relationships to disclose.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc.

Release date: March 2026
Expiration date: March 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Ellis

Ayasun R et al. The role of HER2 status in the biliary tract cancers. Cancers (Basel) 2023;15(9):2628. Abstract

Bartley AN et al. HER2 testing and clinical decision making in gastroesophageal adenocarcinoma: Guideline from the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. J Clin Oncol 2017;35(4):446-44. Abstract

Harding JJ et al. Landmark analysis of overall survival (OS) by objective response in patients (pts) with previously treated, advanced HER2-positive biliary tract cancer (BTC): Post hoc analysis of the HERIZON-BTC-01 trial. Gastrointestinal Cancers Symposium 2026;Abstract 545.

Harding JJ et al. HERIZON-BTC-302: A phase 3 study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). Gastrointestinal Cancers Symposium 2025;Abstract TPS648.

Ikeda M et al. Randomized, open-label, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care (SOC) in first-line, human epidermal growth factor receptor 2 (HER2)-expressing, locally advanced or metastatic (LA/m) biliary tract cancer (BTC): DESTINY-BTC01. ESMO 2024;Abstract 261TiP.

Inoue K et al. Clinicomolecular profile and efficacy of human epidermal growth factor receptor 2 (HER2)-targeted therapy for HER2-amplified advanced biliary tract cancer. JCO Precis Oncol 2025:e2400718. Abstract

Kehmann L et al. Evolving therapeutic landscape of advanced biliary tract cancer: From chemotherapy to molecular targets. ESMO Open 2024;9(10):103706. Abstract

Lamarca A et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): A phase 3, open-label, randomised, controlled trial. Lancet Oncol 2021;22(5):690-701. Abstract

Lee C et al. Impact of HER2-positivity on prognosis and targeted therapeutic outcomes in advanced biliary tract cancer. Gastrointestinal Cancers Symposium 2025;Abstract 629.

Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract

Oh D-Y et al. Durvalumab plus chemotherapy in advanced biliary tract cancer: 3-year overall survival update from the phase III TOPAZ-1 study. J Hepatol 2025;83(5):1092-101. Abstract

Ohba A et al. Trastuzumab deruxtecan in human epidermal growth factor receptor 2–expressing biliary tract cancer (HERB; NCCH1805): A multicenter, single-arm, phase II trial. J Clin Oncol 2024;42(27):3207-17. Abstract

Pant S et al. Zanidatamab in HER2-positive metastatic biliary tract cancer: Final results from HERIZON-BTC-01. JAMA Oncol 2025;12(1):106-9. Abstract

Søreide K et al. Biliary tract cancer. Eur J Surg Oncol 2025;51(6):108489. Abstract

Dr Wainberg

Cammarota A et al. Targeting HER2 in gastroesophageal cancer: A new appetite for an old plight. Drugs 2025;85(3):361-83. Abstract

Elimova E et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. Gastrointestinal Cancer Symposium 2026;Abstract LBA285.

Elimova E et al. Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: Primary results of a multicentre, single-arm, phase 2 study. Lancet Oncol 2025;26(7):847-59. Abstract

Janjigian YY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO 2024;Abstract 1400O.

Janjigian YY et al. Trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients (pts) with advanced/metastatic HER2-positive (HER2+) esophageal, gastric or gastroesophageal junction adenocarcinoma (GEJA): DESTINY-Gastric03 (DG-03). ESMO 2024;Abstract 1401O.

Jubashi A et al. Prognostic and predictive factors for the efficacy and safety of trastuzumab deruxtecan in HER2-positive gastric or gastroesophageal junction cancer. Gastric Cancer 2025;28(1):63-73. Abstract

Klempner et al. ERBB2 copy number (CN) as a quantitative biomarker for real-world (RW) outcomes to anti-HER2 therapy in advanced gastroesophageal adenocarcinoma (adv GEA). ASCO 2021;Abstract 4045.

Shitara K et al. An open-label, randomized, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) + chemotherapy (chemo) ± pembrolizumab (pembro) versus chemo + trastuzumab ± pembro in first-line metastatic HER2+ gastric or gastroesophageal junction (GEJ) cancer: DESTINY-Gastric05. ASCO 2025;Abstract TPS4207.

Shitara K et al. Trastuzumab deruxtecan or ramucirumab plus paclitaxel in gastric cancer. N Engl J Med 2025;393(4):336-48. Abstract

Shitara K et al. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: Exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial. Nat Med 2024;30(7):1933-42. Abstract

Yamaguchi K et al. Trastuzumab deruxtecan in anti-human epidermal growth factor receptor 2 treatment-naive patients with human epidermal growth factor receptor 2-low gastric or gastroesophageal junction adenocarcinoma: Exploratory cohort results in a phase II trial. J Clin Oncol 2023;41(4):816-25. Abstract

Yang H et al. Oesophageal cancer. Lancet 2024;404(10466):1991-2005. Abstract

Prof Van Cutsem

Germani MM et al. Impact of human epidermal growth factor receptor 2 in patients with metastatic colorectal cancer treated with chemotherapy plus bevacizumab or anti-EGFRs: Exploratory analysis of eight randomized trials. J Clin Oncol 2025;43(29):3184-97. Abstract

Meric-Bernstam F et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: A phase 1, dose-escalation and expansion study. Lancet Oncol 2022;23(12):1558-70. Abstract

Oh D-Y, Bang Y-J. HER2-targeted therapies – A role beyond breast cancer. Nat Rev Clin Oncol 2020;17(1):33-48. Abstract

Raghav K et al. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): Primary results from a multicentre, randomised, phase 2 trial. Lancet Oncol 2024;25(9):1147-62. Abstract

Rha SY et al. Zanidatamab (Zani) + chemotherapy (CT) in first-line (1L) human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic colorectal cancer (mCRC). ESMO 2024;Abstract 516MO.

Sartore-Bianchi A et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): A proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol 2016;17(6):738-46. Abstract

Strickler JH et al. MOUNTAINEER-03 phase III study design: First-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer. Future Oncol 2025;21(3):303-11. Abstract

Strickler JH et al. Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER). ASCO 2024;Abstract 3509.

Vaghi C et al. Targeting HER2 in metastatic colorectal cancer: Current therapies, biomarker refinement, and emerging strategies. Drugs 2026;86(1):37-57. Abstract

Yoshino T et al. Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer. Nat Commun 2023;14(1):3332. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of gastrointestinal cancers.

LEARNING OBJECTIVES

• Appreciate the prevalence and clinical relevance of human epidermal growth factor receptor 2 (HER2) amplification or overexpression in various GI cancers, and consider the implications for biomarker assessment and clinical management.
• Evaluate published clinical trial findings with HER2-directed therapies for HER2-positive biliary tract cancers, and optimally incorporate available agents into the clinical care of appropriately selected patients.
• Appraise the side effects associated with HER2-directed therapies with established efficacy in GI cancers, and use this information to develop supportive management plans for patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Proceedings: Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Program: ResearchToPractice.com/ASCOGI26/HER2PosGI/Micro/2/Video and evaluation ResearchToPractice.com/ASCOGI26/HER2PosGI/Micro/2/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Haley Ellis, MD
Medical Oncologist 
Mass General Brigham Cancer Institute 
Harvard Medical School 
Boston, Massachusetts 

Advisory Committees: AstraZeneca Pharmaceuticals LP, Cogent Biosciences, Jazz Pharmaceuticals Inc; Honoraria: Incyte Corporation, Jazz Pharmaceuticals Inc; Nonrelevant Financial Relationships: Medscape, OncLive, The Jackson Laboratory.

Eric Van Cutsem, MD, PhD
Professor of Medicine
Digestive Oncology
University Hospitals Leuven
Leuven, Belgium

Consulting Agreements: AbbVie Inc, Agenus Inc, ALX Oncology, Amgen Inc, Arcus Biosciences, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, BioNTech SE, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cantargia, Daiichi Sankyo Inc, Debiopharm, Eisai Inc, ElmediX, Fosun Pharma, Galapagos NV, GSK, Incyte Corporation, Ipsen Biopharmaceuticals Inc, iTeos Therapeutics, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck KGaA, Microbial Machines, Mirati Therapeutics Inc, MSD, Nordic Pharma, Novartis, Novocure Inc, Pfizer Inc, Pierre Fabre, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, Simcere, Taiho Oncology Inc, Takeda Pharmaceutical Company Limited, Trishula Therapeutics, Zymeworks Inc.

Zev Wainberg, MD, MSc
Co-Director, GI Oncology Program
Director of Early Phase Clinical Research
Jonsson Comprehensive Cancer Center
UCLA School of Medicine
Los Angeles, California

Consulting Agreements: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Gilead Sciences Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Novartis, Novocure Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Arcus Biosciences, Bristol Myers Squibb; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Pfizer Inc.

MODERATOR
Lionel A Kankeu Fonkoua, MD
Senior Associate Consultant
Assistant Professor of Oncology
Division of Medical Oncology, GI Cancer Program
Mayo Clinic
Rochester, Minnesota

No relevant financial relationships to disclose.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc.

Release date: March 2026
Expiration date: March 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Ellis

Ayasun R et al. The role of HER2 status in the biliary tract cancers. Cancers (Basel) 2023;15(9):2628. Abstract

Bartley AN et al. HER2 testing and clinical decision making in gastroesophageal adenocarcinoma: Guideline from the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. J Clin Oncol 2017;35(4):446-44. Abstract

Harding JJ et al. Landmark analysis of overall survival (OS) by objective response in patients (pts) with previously treated, advanced HER2-positive biliary tract cancer (BTC): Post hoc analysis of the HERIZON-BTC-01 trial. Gastrointestinal Cancers Symposium 2026;Abstract 545.

Harding JJ et al. HERIZON-BTC-302: A phase 3 study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). Gastrointestinal Cancers Symposium 2025;Abstract TPS648.

Ikeda M et al. Randomized, open-label, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care (SOC) in first-line, human epidermal growth factor receptor 2 (HER2)-expressing, locally advanced or metastatic (LA/m) biliary tract cancer (BTC): DESTINY-BTC01. ESMO 2024;Abstract 261TiP.

Inoue K et al. Clinicomolecular profile and efficacy of human epidermal growth factor receptor 2 (HER2)-targeted therapy for HER2-amplified advanced biliary tract cancer. JCO Precis Oncol 2025:e2400718. Abstract

Kehmann L et al. Evolving therapeutic landscape of advanced biliary tract cancer: From chemotherapy to molecular targets. ESMO Open 2024;9(10):103706. Abstract

Lamarca A et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): A phase 3, open-label, randomised, controlled trial. Lancet Oncol 2021;22(5):690-701. Abstract

Lee C et al. Impact of HER2-positivity on prognosis and targeted therapeutic outcomes in advanced biliary tract cancer. Gastrointestinal Cancers Symposium 2025;Abstract 629.

Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract

Oh D-Y et al. Durvalumab plus chemotherapy in advanced biliary tract cancer: 3-year overall survival update from the phase III TOPAZ-1 study. J Hepatol 2025;83(5):1092-101. Abstract

Ohba A et al. Trastuzumab deruxtecan in human epidermal growth factor receptor 2–expressing biliary tract cancer (HERB; NCCH1805): A multicenter, single-arm, phase II trial. J Clin Oncol 2024;42(27):3207-17. Abstract

Pant S et al. Zanidatamab in HER2-positive metastatic biliary tract cancer: Final results from HERIZON-BTC-01. JAMA Oncol 2025;12(1):106-9. Abstract

Søreide K et al. Biliary tract cancer. Eur J Surg Oncol 2025;51(6):108489. Abstract

Dr Wainberg

Cammarota A et al. Targeting HER2 in gastroesophageal cancer: A new appetite for an old plight. Drugs 2025;85(3):361-83. Abstract

Elimova E et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. Gastrointestinal Cancer Symposium 2026;Abstract LBA285.

Elimova E et al. Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: Primary results of a multicentre, single-arm, phase 2 study. Lancet Oncol 2025;26(7):847-59. Abstract

Janjigian YY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO 2024;Abstract 1400O.

Janjigian YY et al. Trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients (pts) with advanced/metastatic HER2-positive (HER2+) esophageal, gastric or gastroesophageal junction adenocarcinoma (GEJA): DESTINY-Gastric03 (DG-03). ESMO 2024;Abstract 1401O.

Jubashi A et al. Prognostic and predictive factors for the efficacy and safety of trastuzumab deruxtecan in HER2-positive gastric or gastroesophageal junction cancer. Gastric Cancer 2025;28(1):63-73. Abstract

Klempner et al. ERBB2 copy number (CN) as a quantitative biomarker for real-world (RW) outcomes to anti-HER2 therapy in advanced gastroesophageal adenocarcinoma (adv GEA). ASCO 2021;Abstract 4045.

Shitara K et al. An open-label, randomized, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) + chemotherapy (chemo) ± pembrolizumab (pembro) versus chemo + trastuzumab ± pembro in first-line metastatic HER2+ gastric or gastroesophageal junction (GEJ) cancer: DESTINY-Gastric05. ASCO 2025;Abstract TPS4207.

Shitara K et al. Trastuzumab deruxtecan or ramucirumab plus paclitaxel in gastric cancer. N Engl J Med 2025;393(4):336-48. Abstract

Shitara K et al. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: Exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial. Nat Med 2024;30(7):1933-42. Abstract

Yamaguchi K et al. Trastuzumab deruxtecan in anti-human epidermal growth factor receptor 2 treatment-naive patients with human epidermal growth factor receptor 2-low gastric or gastroesophageal junction adenocarcinoma: Exploratory cohort results in a phase II trial. J Clin Oncol 2023;41(4):816-25. Abstract

Yang H et al. Oesophageal cancer. Lancet 2024;404(10466):1991-2005. Abstract

Prof Van Cutsem

Germani MM et al. Impact of human epidermal growth factor receptor 2 in patients with metastatic colorectal cancer treated with chemotherapy plus bevacizumab or anti-EGFRs: Exploratory analysis of eight randomized trials. J Clin Oncol 2025;43(29):3184-97. Abstract

Meric-Bernstam F et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: A phase 1, dose-escalation and expansion study. Lancet Oncol 2022;23(12):1558-70. Abstract

Oh D-Y, Bang Y-J. HER2-targeted therapies – A role beyond breast cancer. Nat Rev Clin Oncol 2020;17(1):33-48. Abstract

Raghav K et al. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): Primary results from a multicentre, randomised, phase 2 trial. Lancet Oncol 2024;25(9):1147-62. Abstract

Rha SY et al. Zanidatamab (Zani) + chemotherapy (CT) in first-line (1L) human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic colorectal cancer (mCRC). ESMO 2024;Abstract 516MO.

Sartore-Bianchi A et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): A proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol 2016;17(6):738-46. Abstract

Strickler JH et al. MOUNTAINEER-03 phase III study design: First-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer. Future Oncol 2025;21(3):303-11. Abstract

Strickler JH et al. Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER). ASCO 2024;Abstract 3509.

Vaghi C et al. Targeting HER2 in metastatic colorectal cancer: Current therapies, biomarker refinement, and emerging strategies. Drugs 2026;86(1):37-57. Abstract

Yoshino T et al. Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer. Nat Commun 2023;14(1):3332. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of gastrointestinal cancers.

LEARNING OBJECTIVES

• Review published and emerging research findings with human epidermal growth factor receptor 2 (HER2)-targeted therapies for patients with HER2-positive or HER2-low gastroesophageal cancers, and assess their current and future roles in treatment.
• Appreciate the clinical relevance of HER2 amplification or mutation for colorectal cancer, and consider the implications for biomarker assessment and clinical management.
• Evaluate published clinical trial findings with HER2-directed therapies for HER2-positive metastatic colorectal cancer, and optimally incorporate available agents into the clinical care of appropriately selected patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Proceedings: Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Program: ResearchToPractice.com/ASCOGI26/HER2PosGI/Micro/3/Video and evaluation ResearchToPractice.com/ASCOGI26/HER2PosGI/Micro/3/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Haley Ellis, MD
Medical Oncologist 
Mass General Brigham Cancer Institute 
Harvard Medical School 
Boston, Massachusetts 

Advisory Committees: AstraZeneca Pharmaceuticals LP, Cogent Biosciences, Jazz Pharmaceuticals Inc; Honoraria: Incyte Corporation, Jazz Pharmaceuticals Inc; Nonrelevant Financial Relationships: Medscape, OncLive, The Jackson Laboratory.

Eric Van Cutsem, MD, PhD
Professor of Medicine
Digestive Oncology
University Hospitals Leuven
Leuven, Belgium

Consulting Agreements: AbbVie Inc, Agenus Inc, ALX Oncology, Amgen Inc, Arcus Biosciences, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, BioNTech SE, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cantargia, Daiichi Sankyo Inc, Debiopharm, Eisai Inc, ElmediX, Fosun Pharma, Galapagos NV, GSK, Incyte Corporation, Ipsen Biopharmaceuticals Inc, iTeos Therapeutics, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck KGaA, Microbial Machines, Mirati Therapeutics Inc, MSD, Nordic Pharma, Novartis, Novocure Inc, Pfizer Inc, Pierre Fabre, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, Simcere, Taiho Oncology Inc, Takeda Pharmaceutical Company Limited, Trishula Therapeutics, Zymeworks Inc.

Zev Wainberg, MD, MSc
Co-Director, GI Oncology Program
Director of Early Phase Clinical Research
Jonsson Comprehensive Cancer Center
UCLA School of Medicine
Los Angeles, California

Consulting Agreements: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Gilead Sciences Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Novartis, Novocure Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Arcus Biosciences, Bristol Myers Squibb; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Pfizer Inc.

MODERATOR
Lionel A Kankeu Fonkoua, MD
Senior Associate Consultant
Assistant Professor of Oncology
Division of Medical Oncology, GI Cancer Program
Mayo Clinic
Rochester, Minnesota

No relevant financial relationships to disclose.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc.

Release date: April 2026
Expiration date: April 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Ellis

Ayasun R et al. The role of HER2 status in the biliary tract cancers. Cancers (Basel) 2023;15(9):2628. Abstract

Bartley AN et al. HER2 testing and clinical decision making in gastroesophageal adenocarcinoma: Guideline from the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. J Clin Oncol 2017;35(4):446-44. Abstract

Harding JJ et al. Landmark analysis of overall survival (OS) by objective response in patients (pts) with previously treated, advanced HER2-positive biliary tract cancer (BTC): Post hoc analysis of the HERIZON-BTC-01 trial. Gastrointestinal Cancers Symposium 2026;Abstract 545.

Harding JJ et al. HERIZON-BTC-302: A phase 3 study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). Gastrointestinal Cancers Symposium 2025;Abstract TPS648.

Ikeda M et al. Randomized, open-label, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care (SOC) in first-line, human epidermal growth factor receptor 2 (HER2)-expressing, locally advanced or metastatic (LA/m) biliary tract cancer (BTC): DESTINY-BTC01. ESMO 2024;Abstract 261TiP.

Inoue K et al. Clinicomolecular profile and efficacy of human epidermal growth factor receptor 2 (HER2)-targeted therapy for HER2-amplified advanced biliary tract cancer. JCO Precis Oncol 2025:e2400718. Abstract

Kehmann L et al. Evolving therapeutic landscape of advanced biliary tract cancer: From chemotherapy to molecular targets. ESMO Open 2024;9(10):103706. Abstract

Lamarca A et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): A phase 3, open-label, randomised, controlled trial. Lancet Oncol 2021;22(5):690-701. Abstract

Lee C et al. Impact of HER2-positivity on prognosis and targeted therapeutic outcomes in advanced biliary tract cancer. Gastrointestinal Cancers Symposium 2025;Abstract 629.

Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract

Oh D-Y et al. Durvalumab plus chemotherapy in advanced biliary tract cancer: 3-year overall survival update from the phase III TOPAZ-1 study. J Hepatol 2025;83(5):1092-101. Abstract

Ohba A et al. Trastuzumab deruxtecan in human epidermal growth factor receptor 2–expressing biliary tract cancer (HERB; NCCH1805): A multicenter, single-arm, phase II trial. J Clin Oncol 2024;42(27):3207-17. Abstract

Pant S et al. Zanidatamab in HER2-positive metastatic biliary tract cancer: Final results from HERIZON-BTC-01. JAMA Oncol 2025;12(1):106-9. Abstract

Søreide K et al. Biliary tract cancer. Eur J Surg Oncol 2025;51(6):108489. Abstract

Dr Wainberg

Cammarota A et al. Targeting HER2 in gastroesophageal cancer: A new appetite for an old plight. Drugs 2025;85(3):361-83. Abstract

Elimova E et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. Gastrointestinal Cancer Symposium 2026;Abstract LBA285.

Elimova E et al. Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: Primary results of a multicentre, single-arm, phase 2 study. Lancet Oncol 2025;26(7):847-59. Abstract

Janjigian YY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO 2024;Abstract 1400O.

Janjigian YY et al. Trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients (pts) with advanced/metastatic HER2-positive (HER2+) esophageal, gastric or gastroesophageal junction adenocarcinoma (GEJA): DESTINY-Gastric03 (DG-03). ESMO 2024;Abstract 1401O.

Jubashi A et al. Prognostic and predictive factors for the efficacy and safety of trastuzumab deruxtecan in HER2-positive gastric or gastroesophageal junction cancer. Gastric Cancer 2025;28(1):63-73. Abstract

Klempner et al. ERBB2 copy number (CN) as a quantitative biomarker for real-world (RW) outcomes to anti-HER2 therapy in advanced gastroesophageal adenocarcinoma (adv GEA). ASCO 2021;Abstract 4045.

Shitara K et al. An open-label, randomized, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) + chemotherapy (chemo) ± pembrolizumab (pembro) versus chemo + trastuzumab ± pembro in first-line metastatic HER2+ gastric or gastroesophageal junction (GEJ) cancer: DESTINY-Gastric05. ASCO 2025;Abstract TPS4207.

Shitara K et al. Trastuzumab deruxtecan or ramucirumab plus paclitaxel in gastric cancer. N Engl J Med 2025;393(4):336-48. Abstract

Shitara K et al. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: Exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial. Nat Med 2024;30(7):1933-42. Abstract

Yamaguchi K et al. Trastuzumab deruxtecan in anti-human epidermal growth factor receptor 2 treatment-naive patients with human epidermal growth factor receptor 2-low gastric or gastroesophageal junction adenocarcinoma: Exploratory cohort results in a phase II trial. J Clin Oncol 2023;41(4):816-25. Abstract

Yang H et al. Oesophageal cancer. Lancet 2024;404(10466):1991-2005. Abstract

Prof Van Cutsem

Germani MM et al. Impact of human epidermal growth factor receptor 2 in patients with metastatic colorectal cancer treated with chemotherapy plus bevacizumab or anti-EGFRs: Exploratory analysis of eight randomized trials. J Clin Oncol 2025;43(29):3184-97. Abstract

Meric-Bernstam F et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: A phase 1, dose-escalation and expansion study. Lancet Oncol 2022;23(12):1558-70. Abstract

Oh D-Y, Bang Y-J. HER2-targeted therapies – A role beyond breast cancer. Nat Rev Clin Oncol 2020;17(1):33-48. Abstract

Raghav K et al. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): Primary results from a multicentre, randomised, phase 2 trial. Lancet Oncol 2024;25(9):1147-62. Abstract

Rha SY et al. Zanidatamab (Zani) + chemotherapy (CT) in first-line (1L) human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic colorectal cancer (mCRC). ESMO 2024;Abstract 516MO.

Sartore-Bianchi A et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): A proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol 2016;17(6):738-46. Abstract

Strickler JH et al. MOUNTAINEER-03 phase III study design: First-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer. Future Oncol 2025;21(3):303-11. Abstract

Strickler JH et al. Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER). ASCO 2024;Abstract 3509.

Vaghi C et al. Targeting HER2 in metastatic colorectal cancer: Current therapies, biomarker refinement, and emerging strategies. Drugs 2026;86(1):37-57. Abstract

Yoshino T et al. Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer. Nat Commun 2023;14(1):3332. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of gastrointestinal cancers.

LEARNING OBJECTIVES

• Recognize the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in colorectal cancer (CRC), and comprehend the rationale for its use in detecting molecular residual disease in patients.
• Appreciate published datasets documenting the clinical utility of ctDNA testing in risk stratification, surveillance and treatment decision-making for patients with CRC, and consider the current and future role of this strategy in personalizing treatment.
• Recall ongoing trials evaluating novel agents and strategies for patients with nonmetastatic CRC, and refer candidates for participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activitiy, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 0.5 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Program: ResearchToPractice.com/ASCOGI26/LocalizedCRC/Micro/3/Video and evaluation ResearchToPractice.com/ASCOGI26/LocalizedCRC/Micro/3/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Stacey A Cohen, MD
Professor
Fred Hutchinson Cancer Center
University of Washington
Seattle, Washington

Advisory Committees: AbbVie Inc, Agenus Inc, Caris Life Sciences, DoMore Diagnostics, Exact Sciences Corporation, Guardant Health, Incyte Corporation, Janssen Biotech Inc, Merck, Pfizer Inc, Roche Laboratories Inc; Data and Safety Monitoring Boards/Committees: GSK.

Jenny Seligmann, MBChB, PhD
Professor of Gastrointestinal Cancer
University of Leeds
Leeds, United Kingdom

No relevant financial relationships to disclose.

MODERATOR
Christopher Lieu, MD
Professor of Medicine
Associate Director for Clinical Research
Director, GI Medical Oncology
University of Colorado Cancer Center
Aurora, Colorado

Consulting Agreements (to Institution): Pfizer Inc; Contracted Research (All to Institution): Genentech, a member of the Roche Group, Janssen Biotech Inc, Sanofi.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from Genentech, a member of the Roche Group, GSK, and Natera Inc. 

Release date: May 2026
Expiration date: May 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Seligmann

André T et al. Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): A randomised, open-label, phase 3 trial. Lancet 2025;405(10476):383-95. Abstract

Cercek A et al. A phase two, single-arm, open-label study with dostarlimab monotherapy in participants with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (AZUR-1). Clin Colorectal Cancer 2025;24(2):325-30. Abstract

Cercek A et al. Nonoperative management of mismatch repair-deficient tumors. N Engl J Med 2025;392(23):2297-308. Abstract

Chalabi M et al. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med 2020;26(4):566-76. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Morton D et al. Preoperative chemotherapy for operable colon cancer: Mature results of an international randomized controlled trial. J Clin Oncol 2023;41(8):1541-52. Abstract

Ochiai K et al. Total neoadjuvant therapy for rectal cancer: Which regimens to use? Cancers (Basel) 2024;16(11):2093. Abstract

Sassun R et al. Oncological outcomes of neoadjuvant chemotherapy versus upfront surgery in locally advanced colon cancer: A systematic review, meta-analysis, and sequential analysis. Ann Surg Oncol 2025;32(9):6720-7. Abstract

Seligmann J et al. Comparison of outcomes in clinical trials of locally advanced dMMR colon cancer: FOxTROT and NICHE-2. ESMO 2025;Abstract 724O.

Dr Lieu

André T et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2009;27(19):3109-16. Abstract

Courneya KS et al. Structured exercise after adjuvant chemotherapy for colon cancer. N Engl J Med 2025;393(1):13-25. Abstract

Martling A et al. Low-dose aspirin for PI3K-altered localized colorectal cancer. N Engl J Med 2025;393(11):1051-64. Abstract

Rasschaert G et al. AZUR-4, a phase 2, open label, randomized study of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer. ASCO 2025;Abstract TPS3649.

Sargent DJ et al. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol 2010;28(20):3219-26. Abstract

Sinicrope FA et al. Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC). ASCO 2025;Abstract LBA1.

Dr Cohen

Bando H et al. A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): The ALTAIR study. Gastrointestinal Cancers Symposium 2025;Abstract LBA22.

Cohen SA et al. Practical recommendations for using ctDNA in clinical decision making. Nature 2023;619(7969):259-68. Abstract

Dasari A et al. Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA): NRG-GI008. ASCO 2025;Abstract TPS3644.

Dasari A et al. Subgroup analyses of safety and efficacy by number and types of prior lines of treatment in FRESCO-2, a global phase III study of fruquintinib in patients with refractory metastatic colorectal cancer. ASCO 2023;Abstract 3604.

Dasari A et al. ctDNA applications and integration in colorectal cancer: An NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol 2020;17(12):757-70. Abstract

Gianni C et al. Cell-free DNA fragmentomics: A promising biomarker for diagnosis, prognosis and prediction of response in breast cancer. Int J Mol Sci 2022;23(22):14197. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Kotaka M et al. Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan. Gastrointestinal Cancers Symposium 2022;Abstract 9.

Maddalena G et al. INTERCEPT Program of circulating tumor DNA (ctDNA) testing for minimal residual disease (MRD) in colorectal cancer (CRC): Results from a prospective clinical cohort. Gastrointestinal Cancers Symposium 2024;Abstract 27.

Morris VK et al. Phase II results of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) phase II/III study. Gastrointestinal Cancers Symposium 2024;Abstract 5.

Nakamura Y et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nat Med 2024;30(11):3272-83. Abstract

Nowak JA et al. Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702. Gastrointestinal Cancers Symposium 2025;Abstract LBA14.

Parikh AR et al. Minimal residual disease detection using a plasma-only circulating tumor DNA assay in patients with colorectal cancer. Clin Cancer Res 2021;27(20):5586-94. Abstract

Rolfo C, Russo A. Liquid biopsy for early stage lung cancer moves ever closer. Nat Rev Clin Oncol 2020;17(9):523-4. Abstract

Shah PK et al. Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort. Gastrointestinal Cancers Symposium 2025;Abstract 15.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: 5-year outcomes of the randomized DYNAMIC trial. Nat Med 2025;31(5):1509-18. Abstract

Tie J et al. Circulating tumor DNA-guided adjuvant therapy in locally advanced colon cancer: The randomized phase 2/3 DYNAMIC-III trial. Nat Med 2025;31(12):4291-300. Abstract

Tie J et al. ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG). ASCO 2025;Abstract 3503.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: Overall survival and updated 5-year results from the randomized DYNAMIC trial. ASCO 2024;Abstract 108.

Zhang GQ et al. Predictive role of circulating tumor DNA in stage III colon cancer treated with celecoxib: A post hoc analysis of the CALGB (Alliance)/SWOG 80702 phase 3 randomized clinical trial. JAMA Oncol 2025:e255144. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of skin cancer.

LEARNING OBJECTIVES

• Recall long-term outcomes with traditional treatment approaches for localized or locally advanced cutaneous squamous cell carcinoma (cSCC), and recognize clinical and histologic features that increase the risk of recurrence after primary therapy.
• Evaluate available research findings with immunotherapeutic agents as a component of neoadjuvant therapy for resectable cSCC in order to identify patients who may be appropriate candidates for this strategy.
• Appreciate recently published Phase III data supporting the use of adjuvant anti-PD-1 antibody therapy after surgery and radiation therapy for patients with high-risk cSCC, and consider the potential clinical utility and practical application of this approach.
• Use available clinical trial evidence to safely and effectively integrate immunotherapeutic approaches into the care of patients with advanced or metastatic cSCC.
• Formulate a long-term plan for the management of locally advanced or metastatic basal cell carcinoma (BCC), incorporating targeted and immunotherapeutic strategies.
• Recollect the rationale for and design of ongoing clinical trials evaluating novel agents and strategies for cSCC and BCC, and appropriately counsel patients about availability and participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 2.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 2.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Program: ResearchToPractice.com/NonmelanomaSkinThinkTank2025/Video and evaluation ResearchToPractice.com/NonmelanomaSkinThinkTank2025/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Nikhil I Khushalani, MD
Senior Member and Vice Chair
Department of Cutaneous Oncology
Moffitt Cancer Center
Tampa, Florida

Advisory Committees and Consulting Agreements: Bristol Myers Squibb, Castle Biosciences Incorporated, Immunocore, Instil Bio, IO Biotech, Iovance Biotherapeutics, Merck, Mural Oncology, MyCareGorithm, Nektar Therapeutics, Novartis, Regeneron Pharmaceuticals Inc, Replimune, Sun Pharmaceutical Industries Ltd; Contracted Research (All to Institution): Bristol Myers Squibb, Celgene Corporation, GSK, HUYABIO International, IDEAYA Biosciences, Merck, Modulation Therapeutics, Novartis, Regeneron Pharmaceuticals Inc, Replimune; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Incyte Corporation; Stock Options — Private Companies: Asensus Surgical; Stock Options/Stock — Public Companies: Bellicum Pharmaceuticals Inc.

Soo J Park, MD
Associate Professor of Medicine and Dermatology
Division of Hematology/Oncology
UC San Diego Moores Cancer Center
San Diego, California

Consulting Agreements: Regeneron Pharmaceuticals Inc, Sun Pharmaceutical Industries Ltd; Contracted Research: Bristol Myers Squibb; Data and Safety Monitoring Boards/Committees: Replimune.

Vishal Anil Patel, MD
Director of Cutaneous Oncology, GW Cancer Center
Director of Dermatologic Surgery, GW Department of Dermatology
Associate Professor of Dermatology and of Medicine (Oncology)
George Washington University School of Medicine and Health Sciences
Washington, DC

Advisory Committees: Almirall, Biofrontera Inc, Regeneron Pharmaceuticals Inc, Sun Pharmaceutical Industries Ltd; Consulting Agreements: Almirall, Biofrontera Inc, Palvella Therapeutics, Regeneron Pharmaceuticals Inc, Sun Pharmaceutical Industries Ltd, Verrica Pharmaceuticals Inc; Contracted Research: Regeneron Pharmaceuticals Inc; Speakers Bureaus: Almirall, Regeneron Pharmaceuticals Inc, Sun Pharmaceutical Industries Ltd.

Evan Wuthrick, MD
Senior Member and Vice Chair, Quality and Safety Radiation Oncology
Moffitt Cancer Center
Tampa, Florida

No relevant financial relationships to disclose.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from Regeneron Pharmaceuticals Inc.

Release date: April 2026
Expiration date: April 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Khushalani

Bossi P et al. Immunotherapy followed by cetuximab in locally advanced/metastatic cutaneous squamous cell carcinomas: The I-TACKLE trial. Eur J Cancer 2025;220:115379. Abstract

Breukers SE et al. Neoadjuvant ipilimumab and nivolumab in resectable cutaneous squamous cell carcinoma: A randomized phase 2 trial. Nat Med 2025;31(12):4055-64. Abstract

Carter JB et al. Outcomes of primary cutaneous squamous cell carcinoma with perineural invasion: An 11-year cohort study. JAMA Dermatol 2013;149(1):35-41. Abstract

Gibson FT et al. Association of cutaneous immune-related adverse events with improved overall survival among patients with cutaneous squamous cell carcinoma treated with palliative programmed death receptor-1 inhibition. J Am Acad Dermatol 2025;92(6):1399-402. Abstract

Gross ND et al. Neoadjuvant cemiplimab and surgery for stage II-IV cutaneous squamous-cell carcinoma: Follow-up and survival outcomes of a single-arm, multicentre, phase 2 study. Lancet Oncol 2023;24(11):1196-205. Abstract

Gross ND et al. Neoadjuvant cemiplimab for stage II to IV cutaneous squamous-cell carcinoma. N Engl J Med 2022;387(17):1557-68. Abstract

Hughes BGM et al. Pembrolizumab for locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma (KEYNOTE-629 study): An open-label, nonrandomized, multicenter, phase II trial. Ann Oncol 2021;32(10):1276-85. Abstract

Huis in’t Veld EA et al. Oncological outcome after lymph node dissection for cutaneous squamous cell carcinoma. Ann Surg Oncol 2023;30(8):5017-26. Abstract

Karia PS et al. Evaluation of American Joint Committee on Cancer, International Union Against Cancer, and Brigham and Women’s Hospital tumor staging for cutaneous squamous cell carcinoma. J Clin Oncol 2014;32(4):327-34. Abstract

Koyfman SA et al. Phase 3 randomized trial (KEYNOTE-630) of adjuvant pembrolizumab (pembro) versus placebo (pbo) for high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) following surgery and radiation (RT). ASCO 2025;Abstract 6000.

Marin-Acevedo JA et al. Cetuximab for immunotherapy-refractory/ineligible cutaneous squamous cell carcinoma. Cancers (Basel) 2023;15(12):3180. Abstract

Migden MR et al. Trial in progress: A phase 3 randomized study of low-dose intralesional cemiplimab versus primary surgery for patients with early-stage cutaneous squamous cell carcinoma (CLEAR CSCC). ASCO 2025;Abstract TPS9612.

Porceddu SV et al. Prognostic subgroups for disease-free survival with cutaneous squamous cell carcinoma of the head and neck: A secondary analysis of a randomized clinical trial. JAMA Otolaryngol Head Neck Surg 2025;151(10):938-45. Abstract

Porceddu SV et al. Postoperative concurrent chemoradiotherapy versus postoperative radiotherapy in high-risk cutaneous squamous cell carcinoma of the head and neck: The randomized phase III TROG 05.01 trial. J Clin Oncol 2018;36(13):1275-83. Abstract

Ran NA et al. Risk factor number and recurrence, metastasis, and disease-related death in cutaneous squamous cell carcinoma. JAMA Dermatol 2025;161(6):597-604. Abstract

Rischin D et al. Adjuvant cemiplimab or placebo in high-risk cutaneous squamous-cell carcinoma. N Engl J Med 2025;393(8):774-85. Abstract

Rischin D et al. Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: Extended follow-up of outcomes and quality of life analysis. J Immunother Cancer 2021;9(8):e002757. Abstract

Ruiz ES et al. Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a pivotal open-label study with a median follow-up of ≥2 years. J Am Acad Dermatol 2026;94(1):48-56. Abstract

Dr Wuthrick

Gross ND et al. Neoadjuvant cemiplimab for stage II to IV cutaneous squamous-cell carcinoma. N Engl J Med 2022;387(17):1557-68. Abstract

Ladwa R et al. Response-adapted surgical and radiotherapy de-escalation in resectable cutaneous squamous cell cancer using pembrolizumab: The De-Squamate study. J Clin Oncol 2025;43(26):2888-96. Abstract

Veness MJ et al. Surgery and adjuvant radiotherapy in patients with cutaneous head and neck squamous cell carcinoma metastatic to lymph nodes: Combined treatment should be considered best practice. Laryngoscope 2005;115(5):870-5. Abstract

Wang JT et al. Predictors of outcome in patients with metastatic cutaneous head and neck squamous cell carcinoma involving cervical lymph nodes: Improved survival with the addition of adjuvant radiotherapy. Head Neck 2012;34(11):1524-8. Abstract

Dr Park

Barker CA et al. Phase II, single-arm trial of induction and concurrent vismodegib with curative-intent radiation therapy for locally advanced, unresectable basal cell carcinoma. J Clin Oncol 2024;42(19):2327-35. Abstract

Bertrand N et al. Vismodegib in neoadjuvant treatment of locally advanced basal cell carcinoma: First results of a multicenter, open-label, phase 2 trial (VISMONEO study): Neoadjuvant vismodegib in locally advanced basal cell carcinoma. EClinicalMedicine 2021;35:100844. Abstract

Chang ALS et al. Pembrolizumab for advanced basal cell carcinoma: An investigator-initiated, proof-of-concept study. J Am Acad Dermatol 2019;80(2):564-6. Abstract

Dummer R et al. Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study. Br J Dermatol 2020;182(6):1369-78. Abstract

Jones GM et al. Neoadjuvant-adjuvant pembrolizumab in resectable advanced basal cell carcinoma of the head and neck: An open-label, single-arm, phase 1b trial. AACR 2024;Abstract 7518.

Lewis KD et al. Final analysis of phase II results with cemiplimab in metastatic basal cell carcinoma after hedgehog pathway inhibitors. Ann Oncol 2024;35(2):221-8. Abstract

Sekulic A et al. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: Final update of the pivotal ERIVANCE BCC study. BMC Cancer 2017;17(1):332. Abstract

Stratigos AJ et al. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: An open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol 2021;22(6):848-57. Abstract

Warrier G et al. Nivolumab (NIVO) +/- relatlimab (RELA) or ipilimumab (IPI) for patients (pts) w/ treatment-naïve or -refractory advanced basal cell carcinoma (aBCC). ESMO 2025;Abstract 1667P.

Dr Patel

Cañueto J et al. Postoperative radiotherapy provides better local control and long-term outcome in selective cases of cutaneous squamous cell carcinoma with perineural invasion. J Eur Acad Dermatol Venereol 2020;34(5):1080-91. Abstract

Conde-Ferreirós A et al. Definition of prognostic subgroups in the T3 stage of the eighth edition of the American Joint Committee on Cancer staging system for cutaneous squamous cell carcinoma: Tentative T3 stage subclassification. J Am Acad Dermatol 2021;85(5):1168-77. Abstract

Dong J et al. Risk factors for recurrent and metastatic cutaneous squamous cell carcinoma in immunocompromised patients. J Am Acad Dermatol 2020;83(5):1473-5. Abstract

Dusendang JR et al. Cohort and nested case-control study of cutaneous squamous cell carcinoma in solid organ transplant recipients, by medication. J Am Acad Dermatol 2022;86(3):598-606. Abstract

Kim Y et al. Adjuvant radiotherapy may not significantly change outcomes in high-risk cutaneous squamous cell carcinomas with clear surgical margins: A systematic review and meta-analysis. J Am Acad Dermatol 2022;86(6):1246-57. Abstract

Lopez A et al. Immunosuppressed patients are at increased risk of local recurrence, metastasis, and disease specific death from cutaneous squamous cell carcinoma. Arch Dermatol Res 2023;315(5):1429-33. Abstract

Mahajan S et al. Restaging [¹⁸F] fludeoxyglucose positron emission tomography/computed tomography scan in recurrent cutaneous squamous cell carcinoma: Diagnostic performance and prognostic significance. J Am Acad Dermatol 2020;82(4):878-86. Abstract

Morgan FC et al. Brigham and Women’s Hospital tumor classification system for basal cell carcinoma identifies patients with risk of metastasis and death. J Am Acad Dermatol 2021;85(3):582-7. Abstract

Morgan FC et al. Factors predictive of recurrence, metastasis, and death from primary basal cell carcinoma 2 cm or larger in diameter. J Am Acad Dermatol 2020;83(3):832-8. Abstract

Ruiz ES et al. Adjuvant radiation following clear margin resection of high T-stage cutaneous squamous cell carcinoma halves the risk of local and locoregional recurrence: A dual-center retrospective study. J Am Acad Dermatol 2022;87(1):87-94. Abstract

Ruiz ES et al. Performance of the American Joint Committee on Cancer Staging Manual, 8th edition vs the Brigham and Women’s Hospital tumor classification system for cutaneous squamous cell carcinoma. JAMA Dermatol 2019;155(7):819-25. Abstract

Ruiz ES et al. The positive impact of radiologic imaging on high-stage cutaneous squamous cell carcinoma management. J Am Acad Dermatol 2017;76(2):217-25. Abstract

Tschetter AJ et al. Long-term clinical outcomes of patients with invasive cutaneous squamous cell carcinoma treated with Mohs micrographic surgery: A 5-year, multicenter, prospective cohort study. J Am Acad Dermatol 2020;82(1):139-48. Abstract