SAKK 24/09: safety and tolerability of bevacizumab plus paclitaxel vs. bevacizumab plus metronomic cyclophosphamide and capecitabine as first-line therapy in patients with HER2-negative advanced stage breast cancer - a multicenter, randomized phase III trial

摘要: Adding bevacizumab to chemotherapy improves response rates and progression-free survival (PFS) in metastatic breast cancer (mBC). We aimed demonstrate decreased toxicity with metronomic chemotherapy/bevacizumab compared paclitaxel/bevacizumab. This multicenter, randomized phase III trial either paclitaxel (arm A) or daily oral capecitabine-cyclophosphamide B) as first-line treatment patients HER2-negative advanced cancer. The primary endpoint was the incidence of selected grade 3–5 adverse events (AE) including: febrile neutropenia, infection, sensory/motor neuropathy, mucositis. Secondary endpoints included objective rate, disease control PFS, overall (OS), quality life (QoL), pharmacoeconomics. study registered prospectively ClinicalTrials.gov, number NCT01131195 on May 25, 2010. Between September 2010 December 2012, 147 were at 22 centers. endpoint-defining AEs similar arm A (25 % [18/71]; 95 % CI 15–35 %) B (24 % [16/68]; 13–34 %; P = 0.96). Objective 58 % (42/73; 0.46–0.69) 50 % (37/74; 0.39–0.61) arms B, respectively (P = 0.45). Median PFS 10.3 months (95 % 8.7–11.3) 8.5 months 6.5–11.9) (P = 0.90). Other secondary efficacy not significantly different between arms. only statistically significant differences QoL less hair loss numbness B. Treatment costs two equivalent. failed meet its a reduced rate prespecified bevacizumab, cyclophosphamide capecitabine.