Breast Cancer Update for Surgeons, Issue 1, 2017 (Video Program)Results of the Phase III West German Study Group PlanB trial: Significance of the 21-gene RS and concordance of prognostic markers in ER-positive, HER2-negative, high-risk node-negative and node-positive BC
4:10 minutes.
TRANSCRIPTION:
DR SPARANO: The PlanB trial is a trial that has been completed and reported. It targeted patients with HER2-negative breast cancer, patients less than or equal to 75 years of age who either were node-positive or high-risk node-negative. The high-risk features included T2 or greater lesions, intermediate or high grade, hormone receptor-negative status or age less than 35, or high uPA/ PAI-1 marker. And there was a randomized component of the trial where patients who were high risk were randomized to receive either 6 cycles of docetaxel and cyclophosphamide or sequential epirubicin/cyclophosphamide followed by docetaxel. Those high-risk patients who were randomized to one chemotherapy regimen or another included those who were hormone receptor-negative or those who were hormone receptor-positive and had high-risk features, which they defined as having at least 4 positive axillary lymph nodes or having 0 to 3 axillary nodes and a Recurrence Score of more than 11. They’ve reported a part of the study. To my knowledge, the results of the randomized component of the study have not yet been reported. But what they have reported are the outcomes for the patients with 0 to 3 lymph nodes and a Recurrence Score of less than or equal to 11 who were assigned to endocrine therapy alone. DR LOVE: So this is really comparable to your data reported in the New England Journal with the TAILORx study. DR SPARANO: Yes, except that their Recurrence Score threshold was a little higher. Not much — it was 11 or lower, rather than 10 or lower. And the other major and more important difference is they did allow patients who had 1 to 3 positive axillary lymph nodes. And they reported their outcomes. And so for the group of patients who had a Recurrence Score of 0 to 11 who were treated with endocrine therapy alone, their 5-year disease-free survival was 94%. For those who had a Recurrence Score of greater than 25 who were treated with chemotherapy plus endocrine therapy, their 5-year disease-free survival was 84%. And for the group that had a Recurrence Score of 12 to 25, their 5-year disease-free survival was 94%. Now, we don’t know the results of the randomized component of the trial. I believe this result indicates the pooled results of both arms. DR LOVE: So what’s the message that you take away from this study? DR SPARANO: I think the message is that patients with low Recurrence Score, we know from TAILORx, who have ER-positive, HER2-negative disease, node-negative disease, have an excellent prognosis at 5 years with just endocrine therapy alone. What this study tells us is that the same may be true for patients who have up to 3 positive axillary nodes. DR LOVE: Although, I don't know. Maybe it’s psychologic, but in my mind it’s kind of different to have a 98%, 99% recurrence free, as opposed to 94%. And I know there’s a lot of scatter and all. But that starts to get into the area that you start thinking about chemo. DR SPARANO: Yes. It’s important to point out that the endpoint that they used was disease-free survival, which included not only recurrence, distant recurrence, but local recurrence and contralateral breast cancer. And this 5-year disease-free survival of 94% is actually exactly what it was in the TAILORx low-risk registry. It was 93.8% in the TAILORx low-risk registry. But the recurrence rate was only about 1%. So most of those other events were actually contralateral breast cancers. |