(HealthDay News) — Adding bevacizumab to chemotherapy for the postsurgical treatment of triple-negative breast cancer does not significantly improve invasive disease-free survival compared with chemotherapy alone, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 4 to 8.
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.
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“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.”