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

• Published in: Japanese journal of clinical oncology 2005-09, Vol.35 (9), p.531-535
• Main Authors: Park, Se Hoon, Sung, Ju Young, Han, Sang-Hoon, Baek, Jeong Heum, Oh, Jae Hwan, Bang, Soo-Mee, Cho, Eun Kyung, Shin, Dong Bok, Lee, Jae Hoon
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - analogs & derivatives; Camptothecin - therapeutic use; chemotherapy; colorectal cancer; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - mortality; Female; Fluorouracil - adverse effects; Fluorouracil - therapeutic use; Humans; Infusions, Intravenous; Korea; Leucovorin - adverse effects; Leucovorin - therapeutic use; Male; Middle Aged; Organoplatinum Compounds - adverse effects; Organoplatinum Compounds - therapeutic use; oxaliplatin; Salvage Therapy; Survival Rate; Treatment Failure; Treatment Outcome
• ISSN: 0368-2811; 1465-3621
• DOI: 10.1093/jjco/hyi140

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.