Adding bevacizumab to neoadjuvant and adjuvant chemotherapy did not provide clinical benefit to patients with non-metastatic, human epidermal growth factor receptor 2 (HER2)-negative inflammatory breast cancer, a study published in the journal The Lancet Oncology has shown.1
Previous studies have demonstrated that the addition of bevacizumab immunotherapy to standard neoadjuvant chemotherapy improves progression-free survival and pathological complete response rate in patients with HER2-negative metastatic breast cancer; however, it is unclear whether adding bevacizumab to chemotherapy improves outcomes of patients with inflammatory breast cancer.
Therefore, researchers conducted a multicenter, single-arm, phase 2 trial to evaluate the addition of bevacizumab to neoadjuvant and adjuvant chemotherapy in the treatment of patients with HER2-negative non-metastatic inflammatory breast cancer.
For the study, researchers enrolled 100 patients who all received neoadjuvant intravenous fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2, and bevacizumab 15 mg/kg every 3 weeks during cycles 1-4. Patients then received docetaxel 100 mg/m2 and bevacizumab 15 mg/kg during cycles 5-8. Two to 4 weeks after surgery, patients underwent adjuvant radiotherapy, adjuvant bevacizumab, and hormone therapy (if they had a hormone receptor-positive tumor).
Results showed that only 19% (95% CI, 12 – 28) of the 100 patients achieved a pathological complete response after neoadjuvant therapy (P = .16).
In terms of safety, the most frequently reported grade 3-4 treatment-related adverse events during the neoadjuvant phase were neutropenia (89%), febrile neutropenia (37%), and mucositis (23%). During the adjuvant phase, the most common was proteinuria (7% of 75 patients).
Of note, 48% of patients experienced a serious adverse event and 1 patient died of thrombotic microangiopathy due to bevacizumab treatment.
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“Longer follow-up and correlative studies to identify patients who might benefit from bevacizumab are needed,” the authors concluded.
- Bertucci F, Fekih M, Autret A, et al. Bevacizumab plus neoadjuvant chemotherapy in patients with HER2-negative inflammatory breast cancer (BEVERLY-1): a multicentre, single-arm, phase 2 study [published online ahead of print March 28, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)00011-5.