Oxaliplatin Added to Simplified Bimonthly Low-Dose Leucovorin and 5-FU for Pretreated Advanced Colorectal Cancer Is Effective and Not Affected by Different Previous 5-FU Regimens

• Published in: Cancer investigation 2004, Vol.22 (2), p.171-179
• Main Authors: Hsieh, Ruey-Kuen, Chao, Tsu-Yi, Chen, Wei-Shon, Yang, Tsai-Shen, Chen, Li-Tzong, Chen, Po-Min, Liu, Jin-Hwang
• Format: Article
• Language: English
• Subjects: 5-FU; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - pathology; Disease-Free Survival; Drug Administration Schedule; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Humans; Infusions, Intravenous; Injections, Intravenous; Leucovorin; Leucovorin - administration & dosage; Leucovorin - adverse effects; Male; Metastatic colorectal cancer; Middle Aged; Organoplatinum Compounds - administration & dosage; Organoplatinum Compounds - adverse effects; Oxaliplatin; Treatment Outcome
• ISSN: 0735-7907; 1532-4192
• DOI: 10.1081/CNV-120030204

This phase II study examined bimonthly oxaliplatin (85 mg m2) added to a continuous infusion of fluorouracil (3000 mg m2 for 46 h following a 400 mg m2 bolus), with leucovorin (LV) (150 mg m2) administrated in a simplified way to patients with metastatic colorectal cancers (CRC) refractory or resistant to 5-fluorouracil (5-FU). Sixty patients were registered. Of the 52 evaluable patients, 3 (5.8%) achieved a complete response (CR) and 18 (34.6%) achieved a partial response (PR). The overall response rate (CR + PR) was 40.4% (95% confidence interval [CI]: 26.6%-54.2%) for evaluable patients and 35% (95% CI: 22.6%-47.4%) by intention to treat. The median progression-free survival (PFS) was 5.2 months, and the median survival was 14.2 months. No significant differences were seen in response rates and PFS of patient groups pretreated either with high-dose 5-FU LV by continuous infusion or with intravenous 5-FU LV by a weekly bolus. From the 421 cycles analyzed, dose-limiting toxicities included cumulative sensory neuropathy and leukopenia, accounting for 11.6% and 10.0%, National Cancer Institute-Common Toxicity Criteria grade 3 4 toxicities per patient, respectively. Two (3.3%) patients experienced hepatic encephalopathy related to high-dose 5-FU. With necessary caution, this regimen was effective for 5-FU-pretreated CRC, regardless of ethnic differences, and it had the advantage of LV being administrated at a low dose in a simplified way.