A Phase II Study of Bevacizumab, Oxaliplatin, and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer A Prospective, Multicenter Trial of the Korean Cancer Study Group

Abstract

Background: Bevacizumab plus doublet chemotherapy has become one of the standard treatments for patients with metastatic colorectal cancer (mCRC). We have investigated the efficacy and safety of bevacizumab plus capecitabine and oxaliplatin as first-line chemotherapy for Korean patients with mCRC. Methods: Patients were treated with bevacizumab 7.5 mg/kg and oxaliplatin 130 mg/m(2) on day 1 and capecitabine 2000 mg/m(2)/d on days 1 to 14. After 9 cycles, patients were entered into the maintenance treatment, consisting of bevacizumab and capecitabine. Treatment was repeated every 3 weeks and response was evaluated every 2 cycles. Results: Of the 49 patients (median age, 57 y), 29 (59%) had primary tumors in the colon, and 31 (63%) had metastases in 2 or more organs. Overall response rate was 71.4% (95% confidence interval [CI], 58.7%-84.1%), median progression-free survival was 10.4 months (95% CI, 8.2-12.5 mo), and median overall survival was 20.0 months (95% CI, 16.7-23.4 mo). Frequent grade 3 toxicities included neuropathy (9, 18.4%), neutropenia (8, 16.3%), diarrhea (6, 12.2%), and thrombocytopenia (3, 6.1%). Bevacizumab-related grade 3 or 4 toxicities included proteinuria (1, 2.0%) and bowel perforation (1, 2.0%). Conclusions: Bevacizumab plus capecitabine and oxaliplatin was well tolerated and showed promising antitumor activity in Korean patients with mCRC.