Axitinib and/or bevacizumab with modified FOLFOX-6 as first-line therapy for metastatic colorectal cancer: A randomized phase 2 study

摘要: BACKGROUND In this multicenter, open-label, randomized phase 2 trial, the authors evaluated vascular endothelial growth factor receptor inhibitor axitinib, bevacizumab, or both in combination with chemotherapy as first-line treatment of metastatic colorectal cancer (mCRC). METHODS Patients previously untreated mCRC were 1:1:1 to receive continuous axitinib 5 mg twice daily, bevacizumab mg/kg every weeks, daily plus each modified 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX-6). The primary endpoint was objective response rate (ORR). RESULTS In all, 126 patients enrolled from August 2007 September 2008. ORR numerically inferior arm (n = 42) versus (n = 43; 28.6% vs 48.8%; 1-sided P = .97). Progression-free survival (PFS) (11.0 months 15.9 months; P = .57) and overall (OS) (18.1 21.6 P = .69) also arm. Similarly, efficacy endpoints for axitinib/bevacizumab (n = 41) (ORR, 39%; PFS, 12.5 OS, 19.7 months). who received had fewer cycles compared other arms. Common all-grade adverse events across all 3 arms fatigue, diarrhea, nausea (all ≥49%). Hypertension headache more frequent axitinib. Patients longest exposures highest rates peripheral neuropathy. CONCLUSIONS Neither addition nor FOLFOX-6 improved ORR, OS mCRC. Cancer 2013;119:2555–2563. © 2013 American Society.