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Japanese Journal of Clinical Oncology Advance Access published online on July 18, 2005
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyi140
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© 2005 Foundation for Promotion of Cancer Research
Received May 1, 2005
Accepted June 19, 2005

Original Article

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 Park 1, Ju Young Sung 1, Sang-Hoon Han 1, Jeong Heum Baek 2, Jae Hwan Oh 2, Soo-Mee Bang 1, Eun Kyung Cho 1, Dong Bok Shin 1*, and Jae Hoon Lee 1

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

* To whom correspondence should be addressed.
Dong Bok Shin, E-mail: dbs{at}gilhospital.com


  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 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.

Keywords: colorectal cancer; oxaliplatin; chemotherapy.
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