Martine Piccart, MD, of the Institut Jules Bordet, Brussels, Belgium, and President-Elect of the European Society for Medical Oncology, was highly enthusiastic about the findings of the phase II T-DM1 study, but said, “We have to remember this is an open-label trial, and in a study like this, events may be attributed to disease progression although they are not truly progression.”
She also said that only 25% of patients in the phase II trial were previously exposed to adjuvant trastuzumab, and the situation is different now, when HER2-positive patients routinely get trastuzumab.
She cited the large difference in adverse events as the major factor in the ability to continue on treatment with T-DM1 vs standard chemotherapy. However, “the control arm in this trial seems to do a little less well than in other trials reported in the literature.”
“We look forward to validation in a comprehensive phase III trial. Then T-DM1 will be available to patients in the not-too-distant future,” Dr. Piccart stated. ■
Disclosure: Dr. Piccart receives consultancy fees from Roche, and her institute receives research grants from Roche.
“This is an exciting drug,” said Hope Rugo, MD, Professor of Medicine at University of California, San Francisco. “It is highly effective and extremely well tolerated, with no hair loss, which is very important to patients. It also enables using a lower dose of trastuzumab.”