[Phase II study of 5-FU tablets in cancer of the uterine cervix]

A phase II study of 5-FU tablet for 52 patients with cancer of the uterine cervix was undertaken by a cooperative study group consisting of 13 institutions. The clinical response rate in 44 evaluable cases was 31.8% (CR: 3 cases, PR: 11 cases, MR: 2 cases, NC: 19 cases and PD: 9 cases). Efficacy rates of 5-FU tablet according to lesion sites were 44.4% in the uterine cervix, 42.9% in the vaginal wall and cut vaginal end, 25.0% in the lymph nodes and 16.7% in the lung. Histologically, the effectiveness rate was 26.9% for large-cell, non-keratinizing-type-carcinoma, 42.9% for small-cell, non-keratinizing-type, and 60.0% for the keratinizing-type of squamous cell carcinoma. One of three adenocarcinoma cases (33.3%) showed improvement. Some adverse effects were observed in 16 (32.0%) of 50 evaluable cases. A large proportion of the adverse effects were gastro-intestinal disorders, such as nausea, vomiting and anorexia. These results suggested that 5-FU tablet is a useful chemotherapeutic agent against carcinoma of the uterine cervix.