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

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 200 mg/m²/day, followed by bolus 5-FU 400 mg/m² and a 22 h infusion of 5-FU 600 mg/m² for two consecutive days. The treatment was repeated every 2 weeks 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 5.4 months. The median progression-free and overall survivals were 2 and 5 months, respectively. Frequently encountered toxicities were peripheral neuropathy and gastrointestinal side effects including diarrhea. Although there was one early death, toxicity profiles were generally 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.