Fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus bevacizumab is a feasible treatment option for certain patients with resectable metastatic colorectal cancer (mCRC), regardless of baseline clinical characteristics and RAS or BRAF mutational status, a new study published online ahead of print in the journal The Lancet Oncology has shown.1
Previous results of the open-label, multicenter, phase 3 TRIBE study demonstrated a significantly improved progression-free survival with FOLFOXIRI plus bevacizumab compared with FOLFIRI plus bevacizumab in patients with mCRC.
For the study, 508 patients aged 18 to 70 years with an ECOG performance status of 2 or less or aged 71 to 75 years with an ECOG performance status of 0 with unresectable mCRC were enrolled.
Patients were randomly assigned 1:1 to receive bevacizumab 5 mg/kg plus FOLFOXIRI (irinotecan 165 mg/m2 IV over 60 minutes, followed by oxaliplatin 85 mg/m2 IV given concurrently with leucovorin 200 mg/m2 IV over 120 minutes, followed by fluorouracil 3200 mg/m2 continuous IV infusion over 48 hours) or FOLFIRI (irinotecan 180 mg/m2 IV over 60 minutes, followed by leucovorin 200 mg/m2 IV over 120 minutes, fluorouracil 400 mg/m2 IV bolus, and fluorouracil 2400 mg/m2 continuous IV infusion over 46 hours).
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Results showed that at median follow-up of 48.1 months, median overall survival was 29.8 months (95% CI: 26.0, 34.3) with FOLFOXIRI plus bevacizumab compared with 25.8 months (95% CI: 22.5, 29.1) with FOLFIRI plus bevacizumab (HR = 0.80; 95% CI: 0.65, 0.98; P=.03).
Subgroup analyses demonstrated a median overall survival of 37.1 months (95% CI: 29.7, 42.7) in patients with RAS and BRAF wild-type mutational status compared with 25.6 months (95% CI: 22.4, 28.6) in those who were RAS mutation-positive (HR = 1.49; 95% CI: 1.11, 1.99) and 13.4 months (95% CI: 8.2, 24.1) in those who were BRAF mutation-positive (HR = 2.79; 95% CI: 1.75, 4.46; P<.0001).
- Cremolini C, Loupakis F, Antoniotti C, et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study [published online ahead of print on August 31, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00122-9.