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Eliminating the anthracycline from Herceptin regimens reduces cardiac complications without worsening survival

October 5, 2011

Eliminating the anthracycline from adjuvant trastuzumab (Herceptin) regimens for HER2-positive early breast cancer reduces cardiac complications while maintaining survival benefits, according to a new study published in the New England Journal of Medicine. In this study, Dr. Dennis Slamon and colleagues evaluated the efficacy and safety of a nonanthracycline regimen with trastuzumab, in hopes of reducing the cardiac toxicity associated with anthracycline regimens.

The investigators randomized 3,222 women with HER2-positive early stage breast cancer  to one of three regimens: 1) doxorubicin and cyclophosphamide followed by docetaxel every three weeks (the control arm), 2) the same regimen plus 52 weeks of trastuzumab, or 3) docetaxel and carboplatin plus 52 weeks of trastuzumab (the nonanthracycline arm). The primary study endpoint was disease-free survival, and overall survival and safety were secondary endpoints.

After a median follow-up of 65 months (about 5 years), there were 656 events. The investigators observed a progression-free and overall survival advantage for the patients receiving trastuzumab, with overall survival rates of 87% in the nontrastuzumab control arm compared to 92% and 91% in the anthracycline and nonanthracycline trastuzumab arms, respectively.  Progression-free and overall survival were similar for the two trastuzumab regimens.  Rates of congestive heart failure and cardiac dysfunction were statistically significantly higher in the patients receiving trastuzumab with an anthracycline than in the nonanthracyline  group.  There were also fewer cases of acute leukemia in patients receiving the trastuzumab-nonanthracycline regimen.  

According to the researchers, "the risk–benefit ratio favored the nonanthracycline regimen over anthracylcine plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia."