UFT plus leucovorin for metastatic colorectal cancer: Japanese experience

In the United States and Europe, the combination of oral UFT plus leucovori n has been reported to produce objective responses and survival rates simil ar to those achieved with standard intravenous 5-fluorouracil plus leucovor in in patients with metastatic colorectal cancer, with reduced toxicity. Ho wever, because knowledge and experience with UFT plus leucovorin are relati vely limited in Japan, we conducted a phase II study to evaluate the safety and efficacy of this combination in Japanese patients with metastatic colo rectal cancer, For the purposes of this study, 20 patients received oral UF T 400 mg/m(2)/day in two divided doses (q 12 h) and a 5-mg tablet of leucov orin (q 8 h). Treatment was administered for 5 days, followed by a 2-day re st period, for a 28-day cycle. There were six partial responses (30%) and o ne complete response (5%) (overall response rate, 35%; 95% confidence inter val, 14.1% to 55.9%), Greater efficacy of UFT plus leucovorin was demonstra ted in patients with lung metastases, with a response rate of 63% (five of eight patients), Patients received a median of 4.5 courses (range, 2 to 12) of therapy. The median duration of survival was 228+ days (range, 81 to 54 0; six patients remain alive). Grade 3 or 4 toxicities toxicities occurred in three patients: diarrhea lit two and mucositis in one. No toxicity-relat ed hospitalization was reported. In summary, this combination showed promis ing activity and an acceptable toxicity profile in the treatment of Japanes e patients with metastatic colorectal cancer.