Expert Point of View: European Perspective

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2.16.9_piccart.jpgMartine 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.

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