Three reports that have already been in the press are being presented today at the San Antonio Breast Cancer Symposium.
The first is the Bolero (Breast Cancer Trials of Oral Everolimus) study, which was familiar to many of us here as it was presented in November at a conference in Europe. What makes this study interesting is that it demonstrates a technique for reversing resistance to an aromatase inhibitor with the drug Everolimus, which is currently used to treat kidney cancer. Everolimus works by targeting the protein called mTor, which is thought to be involved in endocrine resistance. The additional months of progression free survival seen in this study survival may or may not be clinically relevant but it proves that this approach has merit.
Cleopatra (Clinical Evaluation Of Pertuzumab And TRAstuzumab) is similar in that it combined a new drug, pertuzumab, with trastuzumab (Herceptin) which is currently used to treat HER2-positive metastatic breast cancer. This trial found a six-month improvement in progression free survival. Whether this will be clinically relevant remains to be seen, but it does set the stage for trying pertuzumab earlier in an adjuvant trial in women whose tumors are HER2-positive.
The most clinically relevant study I have heard reported is the DCIS prediction model from Genomic Health. We diagnose a lot of DCIS and previous retrospective studies have suggested that most of it does not progress to invasive cancer. Yet we treat it all as if it does. This new test seems to predict which DCIS is clinically relevant and needs a more aggressive approach (radiation and possibly tamoxifen) and which does not. This test can be done on tissue removed at core biopsy and analyzed to help a woman decide how aggressive she wants to be. This will affect women right away!
You can read the studies “Everolimus and Progression-free Survival in Breast Cancer” and “Two Anti-HER2 Antibodies Better than One” as well as the editorial “HER2 Therapy An Abundance of Riches” online in the New England Journal of Medicine.