Combination chemotherapy of biweekly irinotecan (CPT-11) plus tegafur/uracil (UFT) and leucovorin (LV) for patients with metastatic colorectal cancer: phase I/II study in Japanese patients |
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Authors: | Koji Okabayashi Hirotoshi Hasegawa Yoshiyuki Ishii Takashi Endo Hiroki Ochiai Tetsuro Kubota Yuko Kitagawa |
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Affiliation: | (1) Department of Surgery, School of Medicine, Keio University, 35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582, Japan;(2) Department of Surgery, Hiratsuka City Hospital, Kanagawa, Japan;(3) Center for Comprehensive and Advanced Medicine, Keio University Hospital, Tokyo, Japan |
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Abstract: | Purpose We aimed to evaluate the safety and efficacy of combination chemotherapy with biweekly irinotecan (CPT-11) plus oral tegafur/uracil (UFT) and leucovorin (LV) in patients with previously untreated metastatic colorectal adenocarcinoma in phase I/II setting. Patients and methods We recruited 37 patients with histologically proven metastatic colorectal adenocarcinoma. UFT (300 mg/m2 per day) and LV (75 mg/day) were administered orally on days 1–21. CPT-11 was administered intravenously on day 1 and 15, at an initial dose of 60 mg/m2, stepping up to 150 mg/m2 in a traditional phase I fashion. The treatment was repeated every 4 weeks. After patients enrolled into a phase II portion, the efficacy and toxicity of this regimen were also assessed. Results The recommended dose of CPT-11 was determined to be 150 mg/m2. Although one patient had a pulmonary embolism after 60 mg/m2 of CPT-11, the treatment was well tolerated in general. The overall objective response rate was 37.8% (14/37; 95% CI, 22.5–55.2) in all patients. Median progression-free survival was 226 days (95% CI, 133–276). Conclusions Biweekly CPT-11 plus UFT and LV had a reasonable safety profile with manageable toxicity, and had a promising activity in patients with metastatic colorectal cancer. Further trials are indicated based on the promising results observed in this study. |
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Keywords: | Chemotherapy Irinotecan Leucovorin Metastatic colorectal cancer UFT |
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