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Japanese Journal of Clinical Oncology Advance Access originally published online on July 18, 2005
Japanese Journal of Clinical Oncology 2005 35(9):531-535; doi:10.1093/jjco/hyi140
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© 2005 Foundation for Promotion of Cancer Research

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

Se Hoon Park1, Ju Young Sung1, Sang-Hoon Han1, Jeong Heum Baek2, Jae Hwan Oh2, Soo-Mee Bang1, Eun Kyung Cho1, Dong Bok Shin1 and Jae Hoon Lee1

1 Department of Internal Medicine and 2 Department of Anorectal Surgery, Gachon Medical School Gil Medical Center, Incheon, Korea

For reprints and all correspondence: Dong Bok Shin, Division of Hematology and Oncology, Department of Internal Medicine, Gachon Medical School Gil Medical Center, Incheon 405-760, Korea. E-mail: dbs{at}gilhospital.com

Received May 1, 2005; accepted June 19, 2005

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.

Key Words: colorectal cancer • oxaliplatin • chemotherapy


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