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Japanese Journal of Clinical Oncology 32:352-357 (2002)
© 2002 Foundation for Promotion of Cancer Research

Oral Uracil/Ftorafur (UFT) Plus Leucovorin as First-line Chemotherapy and Salvage Therapy with Weekly High-dose 5-Fluorouracil/Leucovorin for the Treatment of Metastatic Colorectal Cancer

Tsai-Shen Yang1, Jeng-Yi Wang2, Reiping Tang2, Kuan-Cheng Hsu2 and Jen-Shi Chen1,+

1 Division of Hematology/Oncology, Department of Internal Medicine and 2 Colorectal Section, Department of Surgery, Chang Gung Memorial Hospital, Taipei, Taiwan

Background: The purpose of this study was to determine the efficacy and toxicity of uracil/ftorafur (UFT) plus oral leucovorin (LV) as first-line chemotherapy for patients with metastatic colorectal cancer and salvage chemotherapy with weekly high-dose 5-fluorouracil (5-FU)/LV 24 h infusion.

Methods: Adult patients with no prior chemotherapy for metastatic diseases were enrolled to receive oral UFT 300 mg/m2/d plus LV 90 mg/d for 28 days. Treatment was given continuously for 28 days followed by a 7 day rest period from all treatment. For UFT failed patients, weekly 24 h infusion of 5-FU 2600 mg/m2 plus LV 100 mg/m2 was used as salvage therapy.

Results: Fifty-one patients with metastatic colorectal cancer were enrolled in the study. The objective response rate was 29.5% [95% confidence interval (CI), 16.8–45.2%] among the 44 evaluable patients and 25.5% in the intent-to-treat population. The median survival for all 51 patients was 16.6 months. The median time to progression was 5.9 months. Diarrhea was the major adverse effect of UFT/LV that made patients reduce dosage. Grade 3 or 4 diarrhea developed in 13.7% of patients. Twenty-six patients were treated with weekly 24 h infusional 5-FU/LV as salvage therapy and only two patients responded.

Conclusion: Our results suggest that this 28 day schedule of UFT/LV regimen may offer a well-tolerated, full oral treatment option with efficacy that appears comparable to that of intravenous 5-FU/LV regimens. Parenteral 5-FU/LV as salvage therapy for UFT refractory patients is not recommended.

+ For reprints and all correspondence: Tsai-Shen Yang, Division of Hematology/Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, 199 Tung Hwa North Road, Taipei, Taiwan. E-mail: tsyangss@ms27.hinet.net


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