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A phase  II  study of S‐1 plus leucovorin ( LV ) given in a 4‐week schedule (2 weeks’ administration followed by 2 weeks’ rest) for patients with untreated metastatic colorectal cancer ( mCRC ) showed that the combination was effective, but grade 3 toxicities (diarrhea, stomatitis and anorexia) occurred at a relatively high rate. In this phase  II  study, we evaluated the efficacy and safety of a 2‐week schedule of S‐1 plus  LV . Patients with  mCRC  received oral S‐1 (40–60 mg) and  LV  (25 mg) twice daily for 1 week, followed by 1 week's rest. Treatment was repeated until disease progression or unacceptable toxicity. The primary endpoint was response rate. The pharmacokinetics of S‐1 and  LV  in Chinese patients were evaluated on day 1 of the first cycle. Seventy‐three patients were enrolled in Japan and China. Of 71 eligible patients, the response rate was 53.5%, and the disease control rate was 83.1%. Median progression‐free survival and median overall survival were 6.5 and 24.3 months, respectively. The incidences of grade 3 toxicities were diarrhea 8.3%, stomatitis 8.3%, anorexia 2.8% and neutropenia 9.7%. There were no treatment‐related deaths. The pharmacokinetics profiles of S‐1 plus  LV  in Chinese patients were similar to those in Japanese patients. This 2‐week schedule of S‐1 plus  LV  showed good efficacy and better tolerability than the 4‐week schedule. This therapy will be the base regimen for  mCRC  to be added by other cytotoxic or molecular‐targeted drugs. The optimized treatment schedule for S‐1 plus  LV  was 1 week on and 1 week off.

Phase II study of S‐1 plus leucovorin in patients with metastatic colorectal cancer: Regimen of 1 week on, 1 week off