Oral tegafur/uracil (UFT), like an intravenous drip with 5-fluorouracil (5-FU)/leucovorin (LV), has been regarded as an active regimen in the treatment of advanced colorectal cancer. In this clinical trial, we evaluate the toxicity and efficacy of regimens containing oral UFT/LV, instead of an intravenous drip with 5-FU/LV, in the treatment of metastatic colorectal cancer. A phase II study involving 39 patients with metastatic colorectal cancer (CRC) who received UFT/LV plus irinotecan (Group A)/oxaliplatin (Group B) alternated with UFT/LV plus oxaliplatin (Group A)/irinotecan (Group B) was evaluated. The overall tumor control rate (CR + PR + SD) was approximately 64%, and median overall survival was approximately 12 months. Of the 547 doses the 39 patients received, 6 events (1.10%) of neutropenia, 5 events (0.91%) of diarrhea, 2 events (0.37%) of stomatitis, and 2 events (0.37%) of anemia were observed. The alternating regimen seems to be effective and well tolerated for patients with metastatic CRC.
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