French Study Suggests No Apparent Benefit of Bevacizumab in Nonmetastatic HER2-Negative Inflammatory Breast Cancer
In a French single-arm phase II study reported in The Lancet Oncology, Bertucci et al found little evidence of benefit from the addition of bevacizumab (Avastin) to neoadjuvant and adjuvant therapies in women with nonmetastatic HER2-negative inflammatory breast cancer.
Study Details
In the study, 100 patients underwent 3-week treatment cycles with neoadjuvant fluorouracil (500 mg/m²), epirubicin (100 mg/m²), cyclophosphamide (500 mg/m²), and bevacizumab (15 mg/kg) during cycles one to four and then docetaxel (100 mg/m²) and bevacizumab during cycles five to eight. At 2 to 4 weeks after surgery, patients received adjuvant radiotherapy, hormone therapy if appropriate, and adjuvant bevacizumab. The primary endpoint was pathologic complete response in breast and axillary lymph nodes after neoadjuvant treatment.
Outcomes
Pathologic complete response was observed in 19 patients (19%, 95% confidence interval = 12%–28%). Median follow-up was 45 months. Three-year and median disease-free survival rates were 57% and 53 months. Three-year overall survival was 75%, and median overall survival was not reached.
The most common grade 3 or 4 adverse events during neoadjuvant treatment were neutropenia (89%), febrile neutropenia (37%), and mucositis (23%); the most common grade 3 or 4 adverse event during adjuvant treatment was proteinuria (7%). One patient died of thrombotic microangiopathy, considered to be related to bevacizumab, and two patients developed transitory heart failure. Serious adverse events occurred in 48% of patients, with febrile neutropenia (28%) being the most common.
The investigators concluded: “Our results suggest that the addition of bevacizumab to neoadjuvant and adjuvant chemotherapy does not provide clinical benefit to patients with non-metastatic HER2-negative inflammatory breast cancer. Longer follow-up and correlative studies to identify patients who might benefit from bevacizumab are needed.”
The study was funded by Roche, La Ligue Nationale contre le Cancer, UNICANCER, and Chugai Pharma.
François Bertucci, MD, of Institut Paoli-Calmettes, Marseille, is the corresponding author of The Lancet Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
