O-0018 Efficacy and Safety of Bevacizumab in Metastatic Colorectal Cancer: Overall and Subgroup Analyses of Pooled Data from Randomized Controlled Trials

Abstract

ABSTRACT Introduction Bevacizumab (BV) with chemotherapy (CT) is a standard treatment for mCRC. This analysis pooled individual patient data from the clinical databases of seven RCTs (phase 2 or 3) of BV in 1st- or 2nd-line treatment to further define clinical outcomes, including within subgroups. Methods Patient data were pooled from 1st-line (AVF2107, NO16966, ARTIST, AVF2192, AVF0780, AGITG MAX) and 2nd-line (ECOG E3200) trials. All analyses were based on the intent-to-treat population. Overall and progression-free survival estimates (OS, PFS) were calculated by Kaplan-Meier methods. To assess differences in time to response variables by treatment arm (CT vs BV + CT), stratified random (overall) and fixed (subgroup comparisons) models were used to estimate pooled hazard ratios (HRs) and 95% confidence intervals (CIs), with each study included as a stratum. Results Of the 3763 pooled patients (CT [n = 1773]; BV + CT [n = 1990]), 58.8% were male, 39.6% were ≥65 years, and 45.7% had an ECOG performance status ≥1. OS and PFS were statistically significantly increased in BV-treated patients vs control patients. Subgroup analyses evaluated survival outcomes according to site of metastases, age, and KRAS status (table). Safety data in this pooled analysis were consistent with the profile of BV from the individual studies. Conclusion The addition of bevacizumab to CT resulted in statistically significant improvements in OS and PFS outcomes for mCRC patients in the overall analysis, with survival benefit extending across subgroups defined by site of metastatic disease, age, and KRAS status. Table I .