Bevacizumab in Combination with FOLFIRI in the First-Line Treatment of Patients with Advanced Colorectal Cancer: A Single-Institution Experience

 Introduction: Bevacizumab combined with IFL (irinotecan, bolus 5-fluorouracil, and leucovorin) has been shown to improve outcomes for patients with metastatic colorectal cancer (mCRC). However, infusional 5-fluorouracil-based combinations are now considered optimal in this setting. We analyzed the efficacy and toxicity of FOLFIRI (irinotecan, infusional 5-fluorouracil, and leucovorin)-bevacizumab in an unselected cohort of consecutive patients with mCRC. Materials and Methods: Patients with unresectable mCRC received bevacizumab 5 mg/kg and irinotecan 180 mg/m² on day 1, leucovorin 200 mg/m² on days 1 and 2, 5-fluorouracil 400 mg/m² bolus, and 600 mg/m² continuous infusion on days 1 and 2, every 14 days. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed. Results: Overall, 127 patients were included (69% male, median age 64 years); 15 patients had diabetes, 40 had hypertension, and 23 were undergoing anticoagulant/antiplatelet therapy. Median PFS was 11.0 months (95% CI 10.0-12.0); median OS was 26.0 months (95% CI 21.9-30.1). The ORR was 55.1% (95% CI 46.3-63.6%), with 12 complete responses, 58 partial responses, and 44 patients with stable disease. Salvage surgery was performed in 31 patients (24%), including 23 with liver metastases and one with lung metastases. Grade 3/4 toxicities included neutropenia (17%), vomiting (6%), and diarrhea (17%); grade 3/4 bevacizumab-related toxicities included hypertension (2%), hemorrhage (2%), and venous (7%) and arterial thromboembolic events (5%). Conclusion: FOLFIRI-bevacizumab was active and tolerable in this cohort of unselected patients with mCRC, resulting in a high surgical rescue rate and prolonged survival.