Phase II study of S-1, a novel oral fluoropyrimidine derivative, in patients with metastatic colorectal carcinoma

摘要: This study set out to evaluate, in patients with metastatic colorectal carcinoma, the efficacy and toxicity of S-1, which contains tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP) potassium oxonate, based on a biochemical modulation 5-fluorouracil (5-FU) targeted at inhibition dihydropyrimidine dehydrogenase (DPD). Sixty-three measurable carcinoma were enrolled into study. None had received prior chemotherapy except for adjuvant setting. S-1 was administered orally twice daily standard dose 80 mg m–2day–1for 28 days followed by 14-day rest. agent is continued until disease progression, unaccepted toxicity, or patient refusal. Twenty-two (35%) 62 eligible achieved PR 95% confidence interval 25–48%. Five 10 history partial remission. The median survival time 12 months. Major adverse reactions included myelosuppressive gastrointestinal toxicities, though their incidence grade 3 4 being 13% neutropenia less than 10% others. 53 treated as outpatients required hospitalization due reactions: These results suggest that achieves similar responses those infusional 5-FU plus leucovorin shows potential another easily manageable toxicity. © 2000 Cancer Research Campaign