Chemotherapy with irinotecan hydrochloride and low-dose cisplatin was tested for the treatment of metastatic colorectal cancer showing resistance to 5-fluorouracil. Eleven consecutive patients with advanced metastatic colorectal cancer (performance status: 0 to 2), who had shown tumor progression on chemotherapy with 5-fluorouracil/leucovorin, were treated with irinotecan (60 mg/m2) plus cisplatin (6 mg/m2) by 90-min intravenous infusion. Treatment was repeated weekly for 3 weeks during admission and then fortnightly on an outpatient basis. Objective responses were observed in four patients (36%; 95% confidence interval: 11%-69%). The median duration of response was 5.5 months and six patients are still alive. The time to disease progression was longer in the no change group (7.0±3.6 months: mean ± SD) than in the responder group (5.5±1.9 months), and there was no difference of median survival between the two groups (10.0 versus 10.3 months). The overall median survival was 8.2 months (range: 4 to 12+ months). This treatment was well tolerated. Six patients experienced grade 1 or 2 leucopenia, while grade I diarrhea and nausea occurred in three and five patients, respectively. Based on the good response, excellent quality of life, and convenience, the present regimen seems to be reasonable second-line outpatient chemotherapy for patients with metastatic colorectal cancer showing resistance to 5-fluorouracil.

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