[Clinical evaluation of leucovorin and 5-fluorouracil]

A randomized early phase II study using l-leucovorin (l-LV) and 5-fluorouracil (5-FU) against gastric cancer and colorectal cancer was conducted on a multi-institutional basis in Japan. The administration schedules: Arm A was 250 mg/m2 of l-LV and 600mg/m2 of 5-FU weekly, arm B was 100mg/m2 of l-LV and 370mg/m2 of 5-FU for 5 consecutive days, and arm C was 10mg/m2 of l-LV and 370mg/m2 of 5-FU for 5 consecutive days. In gastric cancer, the response rates were 35.7% (10/28) in arm A, 25% (7/28) in arm B and 0% (0/17) in arm C. On the other hand, in colorectal cancer, 32.4% (12/37) in arm A, 20% (8/40) in arm B and 11.1% (4/36) in arm C. Then, late phase II study using arm A was conducted for both gastric cancer and colorectal cancer. The response rate was 32.8% (21/64) in gastric cancer and now going in colorectal cancer. The combination of high dose l-LV and 5-FU seemed effective for advanced gastric cancer and colorectal cancer.