1005 Background: E2100, AVADO, and RIBBON-1, three randomized trials in patients with MBC evaluating BV plus first-line chemotherapy regimens (taxane-, anthracycline-, or capecitabine-based), each demonstrated improvement in the primary endpoint of progression-free survival (PFS). Although the trials were not designed to show an overall survival (OS) benefit, it was a secondary endpoint in all trials. We present a meta-analysis of OS in 2,447 patients from these trials using complete survival data for each study. Methods: Kaplan—Meier methodology was used to estimate the median duration of PFS and OS. Stratified log-rank test was used to assess the difference in PFS and OS between treatment arms (control vs. BV+chemo). Stratified hazard ratio (HR) was estimated using the Cox regression model. Each individual study was included as a stratification factor in the stratified analysis. 1-year survival rate was compared using normal approximation method. All p-values were two-sided and tested at the type I error rate of 0.05. Results: 2,447 patients were included (1,008 control; 1,439 BV+chemo). Patient characteristics were well- balanced between the arms (overall median age, 56; hormone receptor-positive, 73%; prior adjuvant chemo, 62%; ≥3 metastatic sites, 40%). Duration of follow-up ranged from 29 (AVADO) to 36 (E2100) months. In the pooled analysis, median PFS improved from 6.7 to 9.2 mo (HR=0.64, p<0.0001) in the BV arms. Pooled results for OS showed no statistically significant difference between the arms (median OS control 26.4 mo, BV+chemo 26.7 mo; HR=0.97, (95% CI, 0.86–1.08, p=0.56). 1 yr survival rate was greater in the BV+chemo arms (control, 76.5%; BV+chemo, 81.6%, p=0.003). Results were consistent across key subgroups. Conclusions: Results from the exploratory analysis of the pooled PFS data show that BV, when combined with first-line chemotherapy (taxane-, anthracycline-, or capecitabine-based regimens), results in clinically meaningful and statistically significant improvements in PFS. Though no statistically significant difference in median OS was seen, the pooled OS data from these trials suggest an early benefit at 1 year. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech, NICRC CCOP-NCI Genentech, Roche Roche Genentech, Roche Genentech
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O’Shaughnessy et al. (2010) studied this question.