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Bevacizumab plus chemotherapy did not extend survival in triple-negative breast cancer
Patients with triple-negative breast cancer treated with bevacizumab plus chemotherapy experienced comparable survival but higher rates of adverse events compared with those who underwent chemotherapy alone, according to results of a phase 3 multicenter study.
The open-label BEATRICE trial included 2,591 patients aged 18 years or older with triple-negative operable primary invasive breast cancer.
The researchers randomly assigned 1,290 patients to chemotherapy alone. The other 1,301 patients underwent chemotherapy, followed by bevacizumab (Avastin, Genentech) 5 mg/kg weekly for 1 year.
At baseline, similar percentages of patients in each group had received anthracycline and taxane therapy, as well as radiotherapy. Nearly two-thirds of patients in each arm had node-negative disease.
Three-year invasive DFS served as the primary endpoint.
Median follow-up was 31.5 months in the chemotherapy arm and 32 months in the bevacizumab arm.
Ninety-two percent of patients in the chemotherapy arm completed treatment.
In the combination arm, 93% of patients completed chemotherapy and 68% completed bevacizumab treatment. Eighteen percent of patients discontinued treatment due to adverse events. The most common adverse events were hypertension, left ventricular dysfunction, proteinuria and left-ventricular ejection fraction decrease.
The rate of 3-year invasive DFS was 82.7% (95% CI, 80.5-85) in the chemotherapy group and 83.7% (95% CI, 81.4-86) in the bevacizumab group.
Distant recurrence occurred in 11% of both groups. The most common sites of recurrence were the lungs, liver and bones.
At data cut-off, researchers reported 107 deaths (8%) in the chemotherapy group and 93 deaths (7%) in the bevacizumab group, a difference that was not statistically significant (HR=.84; 95% CI, 0.64-1.12; P=.23). Breast cancer was the most common cause of death in each group (89% for the chemotherapy group vs. 92% of the bevacizumab group).
Overall, adverse events occurred in 99% of each group, with grade ≥3 adverse events observed in 57% of patients in the chemotherapy group and 72% of patients in the bevacizumab group. The most common grade ≥3 adverse events reported during bevacizumab treatment were hypertension (5%) and proteinuria (2%).
Severe cardiac events occurred in 1% of patients in the bevacizumab arm and fewer than .5% of patients in the chemotherapy arm.
Researchers also conducted VEGF biomarker analysis in 1,178 of the patients. Results suggested patients with high pre-treatment plasma VEGFR-2 may benefit from the addition of bevacizumab to chemotherapy, according to researchers.
“On the basis of our findings, bevacizumab cannot be recommended as adjuvant therapy for breast cancer in the overall population of patients treated in BEATRICE,” the researchers concluded. “Nevertheless, biomarker results suggest that within this population, there might be subsets of patients in whom bevacizumab has an effect. Identification of those patients who stand to benefit most from bevacizumab, in both the metastatic and adjuvant settings, is a priority.”
Disclosure: The researchers report advisory/consultant roles with, research funding and honoraria from, and employment relationships with Amgen, AstraZeneca, Novartis, Pfizer, Roche, Sanofi and other companies.
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