Weekly Paclitaxel, Capecitabine, and Bevacizumab with Maintenance Capecitabine and Bevacizumab As First‐line Therapy for Triple‐negative, Metastatic, or Locally Advanced Breast Cancer: Results from the GINECO A‐TaXel Phase 2 Study

BACKGROUNDThe current study was performed to determine the efficacy and safety of first‐line combination therapy with bevacizumab, paclitaxel, and capecitabine for triple‐negative, locally advanced/metastatic breast cancer (LA/MBC).METHODSPatients with measurable triple‐negative LA/MBC who had received no prior chemotherapy for their disease received 4‐weekly cycles of paclitaxel (80 mg/m2 on days 1, 8, and 15 for up to 6 cycles) combined with capecitabine (800 mg/m2 twice daily on days 1‐5, 8‐12, and 15‐19) and bevacizumab (10 mg/kg on days 1 and 14) repeated every 4 weeks until disease progression or unacceptable toxicity occurred. The primary endpoint was the objective response rate; secondary endpoints were progression‐free survival, duration of response, overall survival, and safety.RESULTSBetween April 2010 and March 2012, 62 eligible patients were enrolled. The median age of the patients was 57 years, 74% had received adjuvant chemotherapy, and 65% had visceral metastases. Patients received a median of 6 cycles (range, 1‐45 cycles). The objective response rate was 77% (95% confidence interval [95% CI] 66%‐88%), including complete response in 19% of patients. The median duration of response was 5.6 months (range, 1.3‐27.6 months). The median progression‐free survival was 7.6 months (95% CI, 6.3‐9.0 months) and the median overall survival was 19.2 months (95% CI, 17.4‐20.9 months). The most common grade ≥3 adverse events were hypertension (35% of patients) and neutropenia (23% of patients); 5% of patients experienced febrile neutropenia. Grade ≥2 hand‐foot syndrome, alopecia, and nail toxicity each occurred in 40% of patients (adverse events were recorded before every cycle and graded according to Common Terminology Criteria for Adverse Events [version 4.0]). Treatment was interrupted because of toxicity in 22% of patients.CONCLUSIONSA triplet regimen of paclitaxel, capecitabine, and bevacizumab followed by maintenance therapy with capecitabine and bevacizumab demonstrated high activity and manageable safety in this difficult‐to‐treat population. Cancer 2016;122:3119–26. © 2016 American Cancer Society.