Clinical study of oxaliplatin plus 5-Fu and CF vs irintecan plus 5-Fu and CF in patients with advanced/metastatic colorectal cancer

Abstract

Objective To observe the effect and toxicity of oxaliplatin plus 5-Fu and CF (FOLFOX) vs irinteean plus 5-Fu and CF (FOLFIRI) in patients with advanced/metastatic colorectal cancer. Methods 67 patients with histologicaly confirmed advanced/metastatic colorectal cancer were non-randomized to enter the study. Patients for FOLFOX: oxaliplatin 85 mg/m2 iv 2 h d1.CF 200 mg/m2 iv 2 h followed by 5-Fu 250 mg iv bolus and 5-Fu 600 mg/m2 iv 22 h d1,2 were given, every 2 weeks as one cycle. FOLFIRI: irinotecan 150 mg/m2 iv d1. CF, 5-Fu do so. Efficacy was evaluated at 4 cycles. Results For 39 patients to FOLFOX and 37 patients to FOLFRI, the objective response rate (CR+PR) was 41.0 % vs 35.1%. The median time to progression was 5.2 months vs. 5.8 months in the FOLFOX and FOLFIRI arm. The median survival time was 13.2 months vs. 14.0 months in the FOLFOX and FOLFIRI arm respectively. The clinical benefit rate was 71.8 % vs 78.4 % in the FOLFOX and FOLFIRI ann respectively. There was no significantly differences between two arms (P>0.05). The most frequently observed toxicity reaction was hematological toxicity nausea/vomiting and neurn-sensory toxicity in FOLFOX arm, and hematological toxicity and diarrhea in FOLFIRI arm. FOLFIRI arm had a remarkably higher incidence rate of grade 3 diarrhea than FOLFOX arm(P<0.025). Conclusion FOLFOX and FOLFIRI arm provid high effective and well tolerable treatment for advanced/ metastatic colorectal cancer. Key words: Colorectal neoplasms; Antineoplastic combined chemotherapy protocols