Although 5-fluorouracil (5-FU) is still the mainstay of systemic treatment for patients with metastatic gastric cancer, many patients do not show satisfactory response to this drug. We treated patients with metastatic gastric cancer resistant to 5-FU with a combination of irinotecan hydrochloride (I) and low-dose cisplatin (P). Twenty-one consecutive patients with advanced metastatic gastric cancer and performance status of 0-2, who had received prior chemotherapy with S-1, but had nonetheless shown unrelenting tumor progression, were treated with 60 mg/m2 of I combined with 6 mg/m2 of P, administered by intravenous infusion over 90 min following premedication with azasetron (I/low-P). I/low-P was repeated weekly for 3 weeks with the patient admitted to hospital, and thereafter, fortnightly on an outpatient basis. Seven, eight and six of the total of 21 patients had liver metastases, lymph node metastases and peritoneal dissemination, respectively. Objective response was observed in 11 of the 21 patients (52%; 95% confidence interval: 31-78%). Two (18%) and nine (82%) of these 11 patients exhibited complete and partial response, respectively. The median duration of the response was 7.9 months. The treatment regimen under study was tolerated very well by the patients. Thirteen of the 21 patients (62%) developed grade 1 or 2 leucopenia, which was the most common adverse reaction recorded. Diarrhea and nausea, grade I in all of the cases, occurred in five (22%) and nine (43%) patients, respectively. Based on its remarkable effectiveness, marked improvement in the quality of life of the patients, and the convenience of its administration, the I/low-P regimen is recommended as a promising second-line chemotherapeutic regimen for patients with metastatic gastric cancer resistant to 5-FU.

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