Edith Perez, MD
At the 2012 San Antonio Breast Cancer Symposium (SABCS) we had the privilege of sitting down with Edith Perez, MD, whose breast cancer research has included groundbreaking work with both trastuzumab and T-DM1. Perez is the deputy director of the Mayo Clinic Cancer Center and practices at Mayo Clinic in Jacksonville, Florida. She is also Director of the Breast Cancer Translational Genomics Program and Serene M. and Frances C. Durling Professor of Medicine at the Mayo Medical School. We spoke with her about key research presented at SABCS, ongoing developments in breast cancer treatment, and the current focal areas of her research.
Oncology & Biotech News: You were one of the authors of a phase III study presented at SABCS that examined eribulin mesylate in advanced breast cancer.1 What were the study results?
This was a very well-conducted global trial evaluating whether eribulin was better than capecitabine for patients with refractory metastatic breast cancer. But the researchers did more than that. They actually enrolled patients who were eligible to receive chemotherapy in the first-, second-, or third-line setting for metastatic disease.
The results demonstrated that eribulin was not better than capecitabine. Specifically, the data show that the two drugs appeared to be fairly similar in terms of efficacy, where efficacy was defined as progression-free and overall survival. There was a little bit of a trend, actually, for improvement of eribulin over capecitabine but it did not reach statistical significance.
Another interesting aspect of this study was that investigators conducted a subset exploratory analysis and there were two subgroups of patients who appeared to potentially benefit more from eribulin compared with capecitabine. They were patients with triple-negative breast cancer and patients with HER2-negative breast cancer.
So, the take-home messages include that there are alternatives for patient management: Either eribulin or capecitabine can be used in the first-, second-, or third-line setting. Additionally, the results provide support for further studies, such as evaluating eribulin in patients with HER2- negative or triple-negative breast cancer.
Please discuss the ongoing research you presented at SABCS that involves identifying genomic predictors of treatment outcomes in the phase III N9831 trial.2
We’re very enthusiastic about the results of our study evaluating the potential role of gene expression profiles with the outcome of patients who participated in our N9831 adjuvant trastuzumab trial. As many people know, we and others conducted the original clinical trials that led to the approval of trastuzumab in the adjuvant setting here in the United States and in many parts of the world. An important fact is that although the results have been impressive, not all patients are cured, even if they receive the best combination therapy with trastuzumab and chemotherapy. Thus, we have focused efforts to interrogate the tissue and blood specimens that we collected from the patients who consented, so that we could better understand the biology and identify factors that may help us better predict responsiveness to therapy.
At this meeting we are reporting, for the first time, gene association findings that correlate with outcomes for patients who enrolled in this translational clinical trial. We found, after many years of work and team collaboration, that at a very high level of statistical significance, with a P
value of less than 0.001, expression of 32 genes correlated with patient outcome. Specifically, 27 of those genes were associated with good outcomes and five correlated with poorer outcomes in patients treated with chemotherapy and trastuzumab.