Oxaliplatin, Folinic Acid and 5-Fluorouracil (FOLFOX-4) Combination Chemotherapy as Second-line Treatment in Advanced Colorectal Cancer Patients with Irinotecan Failure: A Korean Single-center Experience

Abstract

Objective: This study was designed to determine the effectiveness and tolerance of oxaliplatin, folinic acid (FA) and infusional 5-fluorouracil (5-FU) (FOLFOX-4) chemotherapy when used as a second-line treatment in patients with advanced colorectal cancer for whom an irinotecan-containing regimen failed. Methods: Thirty-eight patients with measurable colorectal cancer, progressive after previous irinotecan-containing chemotherapy for metastatic disease, were registered in this trial. Oxaliplatin was administered on day 1 at the dose of 85 mg/m2 as a 2 h infusion, concurrently with FA 200mg/m2/day, followed by bolus 5-FU 400mg/m2 and a 22 h infusion of 5-FU600mg/m2 for two consecutive days. The treatment was repeated every 2weeks until disease progression or unacceptable toxicity occurred or until a patient chose to discontinue the treatment. Results: For 34 patients treated, a total of 183 chemotherapy cycles were administered. In an intent-to-treat analysis, six patients (16%) achieved a partial response that they maintained for 5.4months.Themedianprogression-freeandoverall survivalswere2and5months, respectively. Frequently encountered toxicities were peripheral neuropathy and gastrointestinal side effects includingdiarrhea.Although therewasoneearly death, toxicity profilesweregenerally predictable and manageable. Conclusion: Second-line FOLFOX-4 is a feasible regimen with modest activity for colorectal cancer patients with irinotecan failure. Further clinical trials incorporating novel biological agents are warranted. Key words: colorectal cancer – oxaliplatin – chemotherap