[Report on nationwide pooled data and cohort investigation in UFT phase II study]

Based on the overall results of a UFT phase II study made in 104 institutions in Japan from April of 1979 to September of 1980, there was a response rate of 27.7% with 3 CR cases and 49 PR cases out of 188 stomach cancer cases considered as evaluable according to solid cancer chemotherapy direct efficacy criteria. Other response rates were spleen cancer 25%, gallbladder cancer 25%, liver cancer 19.2%, colorectal cancer 25%, breast cancer 32% and lung cancer 7%. Side effects out of 551 cases were, loss of appetite 24.3%, nausea/vomiting 12.5%, diarrhea 11.1% and other digestive system symptoms mainly. The hematologic side effects were mild, being 6.9%. According to the UFT phase II study, in 438 evaluable cases followed for 5 years after testing, the results were analyzed in terms of therapeutic efficacy and survival time. In 185 stomach cancer cases, 50% survival time was 185 days, with CR + PR cases 336 days, MR + NC cases 183 days, and PD cases 97 days. Colorectal cancer showed a 50% survival time of 227 days in 54 cases, while that for 49 breast cancer cases was 505 days. Total Ftorafur (FT) results using the same criteria from the UFT phase II study revealed, from a comparison of dosage and disease type, that UFT did not enhance FT side effects; rather, it markedly increases effectiveness. Therefore, on the basis of its response rate and the survival time for the cases of digestive system cancer, UFT is considered an effective anticancer agent.