Breast Cancer Update for Surgeons, Issue 1, 2017 (Video Program)TAILORx: Results from the low-risk registry of a prospective trial of adjuvant systemic therapy based on the 21-gene RS for patients with ER-positive, HER2-negative BC
3:36 minutes.
TRANSCRIPTION:
DR SPARANO: The TAILORx trial targeted patients who had node-negative, ER-positive, HER2-negative disease that had a tumor of at least 1.1 centimeters, to be exact — of any grade or high risk — that is, intermediate or high grade T1B lesions, were between the ages of 18 and 75 and for whom no partial breast irradiation was planned. This was a population where, based on NCCN Guidelines at the time that the trial was activated in 2005, where chemotherapy was either recommended or at least should be strongly considered. So the patients were preregistered. If they met the eligibility criteria, they underwent Oncotype DX testing. And then, after the result was available, they were then registered onto the trial on to one of 3 arms that was based on their Recurrence Score. So the trial was designed primarily to determine whether chemotherapy was beneficial in women who had a midrange or intermediate Recurrence Score. And that was the primary study group. We defined that as a Recurrence Score of 11 to 25. And those patients were randomly assigned to receive chemoendocrine therapy, the standard arm, or endocrine or hormonal therapy alone, the experimental arm. DR LOVE: And just to clarify the point you made before, I think is so important, that a lot of people who may be new to oncology don’t realize, which is, as you said, prior to that time — I think it was the 2000 NIH Consensus Conference — pretty much the standard of care was, if the tumor was a centimeter or greater, chemo, even node-negative. DR SPARANO: Yes, absolutely. That guidance was published, as you said, about 2000, 2001. So this was the default position at that time. So we’re still waiting for the results of the randomized arms, of course. There was also a high-risk registry, so patients who had a high Recurrence Score were recommended to receive chemotherapy plus endocrine therapy. And those patients who had a low Recurrence Score, very low, which we defined as less than 11, were assigned to receive endocrine therapy alone. We now know the results of the low-risk registry. There are about 1,600 patients enrolled. And at 5 years, there was about a 1% risk of distant recurrence in that group, so in other words, a low enough risk of recurrence that that patient population would not likely benefit from adjuvant chemotherapy, particularly since we know that the benefit of adjuvant chemo is primarily in preventing early recurrence within 5 years of diagnosis. DR LOVE: And I guess, as you say, we’re waiting for that randomized section of the trial. The other thing that’s out there cooking is the so-called RxPONDER trial. Could you explain what that is? DR SPARANO: Yes. The RxPONDER trial is targeting patients with ER-positive, HER2-negative disease who have 1 to 3 positive axillary nodes, so clearly a group of patients in whom chemotherapy is recommended. And they also undergo Oncotype DX testing. If their Recurrence Score is greater than 25, they receive standard chemotherapy/endocrine therapy. And if it’s less than 25, they’re, similar to TAILORx, randomized to chemoendocrine therapy versus endocrine therapy alone. |