Nonanthracycline Trastuzumab Regimen Safe and Effective
Thursday, October 6, 2011 (Last Updated: 10/07/2011)
THURSDAY, Oct. 6 (HealthDay News) -- A nonanthracycline regimen with adjuvant trastuzumab is safe and effective for women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, according to a study published in the Oct. 6 issue of the New England Journal of Medicine.
Dennis Slamon, M.D., Ph.D., from the University of California in Los Angeles, and colleagues investigated the efficacy and safety of a new nonanthracycline regimen with trastuzumab in 3,222 women with early-stage HER2-positive breast cancer. Participants were randomized to receive doxorubicin and cyclophosphamide followed by docetaxel every three weeks (AC-T) or the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). Disease-free and overall survival, and safety were reported after a median follow-up of 65 months.
The investigators identified 656 disease-free survival events at the time of analysis. The estimated disease-free survival rates at five years were 75, 84, and 81 percent, and overall survival rates were 87, 92, and 91 percent among patients receiving AC-T, AC-T plus trastuzumab, and TCH, respectively. Both the AC-T plus trastuzumab and TCH regimens were superior to AC-T, with no significant differences in the efficacy of the two trastuzumab regimens. The group receiving AC-T plus trastuzumab had significantly higher rates of congestive heart failure and cardiac dysfunction than the TCH group. Seven cases of leukemia were reported in the anthracycline-based regimen groups, and one in the TCH group (subsequent to receiving anthracycline outside the study).
"The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia," the authors write.
Several study authors and the editorial author disclosed financial ties to pharmaceutical companies, including Sanofi-Aventis and Genentech, which partially funded the study.
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