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.
The investigational antibody-drug conjugate T-DM1 improved progression-free survival over standard chemotherapy with docetaxel plus trastuzumab (Herceptin) when given as first-line treatment of HER2-positive metastatic breast cancer, according to an open-label phase II study reported at the 2011...
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