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 irinotecancontaining 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/m 2 as a 2 h infusion, concurrently withFA200mg/m 2 /day,followedbybolus5-FU400mg/m 2 anda22hinfusionof5-FU600mg/m 2 fortwoconsecutivedays.Thetreatmentwasrepeatedevery2weeksuntildiseaseprogressionor 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-freeandoverallsurvivalswere2and5months,respectively. Frequently encountered toxicities were peripheral neuropathy and gastrointestinal side effects includingdiarrhea.Althoughtherewasoneearlydeath,toxicityprofilesweregenerallypredictable 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.