[Phase II study of carmofur (HCFU) fine granules]

A phase II study of a new fluoropyrimidine antitumor agent, carmofur (HCFU) fine granules, was performed in 24 institutions. The eligibility of patients and the criteria of response evaluation were based on the "Japanese Criteria for Evaluation of Clinical Effects of Cancer Chemotherapy on Solid Tumors." Out of 119 patients entered in the study, 65 patients were evaluable: 63 patients among them had measurable or evaluable lesions. Positive responses better than PR (Partial Response) were obtained in five (17.9%) out of 28 patients with gastric cancer, four (36.4%) out of 11 patients with colorectal cancer and five (45.5%) out of 11 patients with breast cancer. The total positive response rate was 22.2%. Optimal doses for the clinical use were ranged from 9 to 18mg/kg, and the median duration of PR was 19.6 weeks. In addition to the similar gastrointestinal toxicities observed in other fluoropyrimidines, hot sensation, pollakiuria and frequent defecation were seen in 12.4%, 10.1% and 3.4% of patients, respectively.