Friday, December 7, 2012 (Last Updated: 12/10/2012)
David Cameron, M.D., from the University of Edinburgh in the United Kingdom, and colleagues conducted an open-label multinational phase III trial involving 2,591 patients with centrally confirmed triple-negative operable primary invasive breast cancer (pT1a-pT3) who had undergone definitive surgery. Patients were randomly allocated in a 1:1 ratio to receive at least four cycles of chemotherapy alone (1,290 patients) or the same chemotherapy plus one year of bevacizumab (1,301 patients).
During a median follow-up of 32 months, the researchers found that the hazard ratio for invasive disease-free survival with chemotherapy plus bevacizumab was 0.87 (P = 0.181). Eight percent of patients assigned to chemotherapy and 7 percent assigned to chemotherapy plus bevacizumab died. Bevacizumab correlated with increased incidence of grade ≥3 congestive heart failure/left ventricular dysfunction (3 versus <1 percent), grade ≥3 hypertension (12 versus <1 percent), and treatment discontinuation (20 versus 2 percent). There was no increase in the risk of fatal adverse events with bevacizumab.
"This study did not confirm the hypothesis that adding bevacizumab to chemotherapy would improve patients' outcomes," Cameron said in a statement. "Therefore, sadly for patients, we have nothing extra to add to chemotherapy for early, triple-negative breast cancer."
Hematology & Oncology
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