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Bevacizumab in combination with either FOLFOX-4 or XELOX-2 in first-line treatment of patients with metastatic colorectal cancer: A multicenter randomized phase II trial of the Gruppo Oncologico dell’Italia Meridionale (GOIM 2802)

Clinical Colorectal Cancer Feb 07, 2020

Maiello E, Di Maggio G, Cordio S, et al. - In this phase II randomized trial, researchers assessed the activity of bevacizumab plus either oxaliplatin, folinic acid and infusional 5-fluorouracil (FOLFOX-4) or capecitabine plus oxaliplatin (XELOX-2) in first-line therapy of metastatic colorectal cancer (mCRC) individuals. Study participants were randomized to first-line bevacizumab in a 1:2 ratio plus either FOLFOX-4 (Arm A), as calibration arm, or XELOX-2 (Arm B), up to 12 cycles. Patients with no improvement were further randomized for bevacizumab maintenance alone or with the same fluoropyrimidine induction. Forty-five individuals were randomized in arm A and 87 in arm B with an objective response rate (ORR) of 55.6% vs 48.3%, respectively. PFS was 10.0 vs 9.9 months and OS was 29.8 vs 25.0 months, respectively, after a median follow-up of 47.2 months. This exploratory analysis demonstrated that, in patients with mCRC, biweekly XELOX-2 plus bevacizumab has comparable ORR as FOLFOX-4 plus bevacizumab. Neutropenia 15/3 and nausea 9/5 were the main grade 3-4 toxicities (% A/B).
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