Bevacizumab plus paclitaxel: An effective and safe service protocol for metastatic breast cancer

Background: Paclitaxel-Bevacizumab bio-chemotherapy combinations have been recently reported to be highly active in the first line for metastatic breast cancer (Miller et al, NEJM 2007). The aim of this study was to evaluate the efficacy of this new approach as a service regimen, out of a clinical trial. Protocol: Eligibility criteria were: Her2 negative, measurable/evaluable metastatic breast cancer; no previous chemotherapy for metastatic disease, no previous exposure to bevacizumab; previous exposure to taxanes as part of adjuvant therapy was permitted; adequate organs reserve and functions; good performance status (PS 0-2); no contra-indications for bevacizumab administration; signing an informed consent for chemotherapy. Bevacizumab (B) 10mg/kg/d on days 1&15 and paclitaxel (P) 90 mg/m2/d on days 1,8,15 q4w were administered until progression or intolerance or lifethreatening toxicity. Patients: 18 patients (F=17, M=1) at a median age of 47y (range 31-75y). Of the 17 women, 9 were pre-menopausal. Three presented with metastatic disease and 16 had either early or locally advanced disease at presentation and developed metastases. All had IDC. Three had triple negative tumors, and 14 had at least one HR positive. Systemic adjuvant/neoadjuvant therapy included chemotherapy (AC, TXTR, CAF,CMF, CNF, ET, taxol) in 12 patients, tamoxifen in 9 patients. First line hormonotherapy for metastatic disease was given to all but 2 patients. Sites of metastases prior to administration of B+P were mostly bone (15 pts), liver (9 pts), and lung (8). Results: 17 the patients got at least 2 cycles of B+P and were evaluable for response and toxicity. Neuropathy was observed in 8 patients, neutropenic fever in 1, and dermatomyositis in 1. Clinical benefit response was impressive in 12/17 patients. Significant PR was observed in 15/17 patients, SD in 1/17 and PD in 1/17. The overall response rate was 88%, and the overall disease-control rate was 94%. Median time to progression was >6mo (range 2 to >11mo). Conclusions: B+P as first line service therapy for metastatic breast cancer is associated with high rate of disease control for a signigficant period of time, and thus should be considered in all HER2 negative cases.