MAVERICC, a phase II study of mFOLFOX6-bevacizumab (BV) vs FOLFIRI-BV as first-line (1L) chemotherapy (CT) in patients (pts) with metastatic colorectal cancer (mCRC): Outcomes by tumor location and KRAS status.

3515Background: Standard 1L mCRC treatment (tx) includes a CT backbone (e.g. modified leucovorin [LV]/5-fluorouracil [5-FU]/oxaliplatin [mFOLFOX6] or LV/ 5-FU/ irinotecan [FOLFIRI]) and a biologic (e.g. BV). The preferred CT backbone for anti-VEGF tx is unknown. MAVERICC (NCT01374425), a global, randomized, open-label, phase 2 trial, assessed efficacy and safety of mFOLFOX6-BV vs FOLFIRI-BV in pts with mCRC. PFS and OS were comparable between FOLFIRI-BV and mFOLFOX-BV (Lenz et al, ASCO GI 2016). Exploratory analyses compared clinical outcomes of the BV-containing tx groups by primary tumor location and baseline (BL) KRAS status. Methods: Pts with mCRC (≥1 measurable metastatic lesion, ECOG performance status ≤1) were randomized 1:1 to BV (5 mg/kg) + mFOLFOX6 or FOLFIRI every 2 wks. Time to PFS and OS for each tx group were estimated by Kaplan–Meier methods, hazard ratios (HR) were estimated by Cox regression, p-values were based on log-rank tests stratified by BL ERCC-1 status and region. Results: 376 pts...