[Phase II study of 5'-DFUR in uterine cervical cancer and ovarian cancer].

A phase II study of 5'-DFUR was conducted in uterine cervical cancer and ovarian cancer by the cooperative study group consisting of 26 institutions. Forty-four cases with uterine cervical cancer and 40 cases with ovarian cancer were enrolled. A daily dose of 800-1,200 mg was administered orally for more than 8 weeks. In 34 evaluable cases with uterine cervical cancer, the overall efficacy rate was 20.6%: CR was shown in 2 cases, PR in 5 cases, MR in 2 cases, NC in 17 cases and PD in 8 cases. Histologically, the response rate was 27.3% in large cell non-keratinizing type, 20.0% in small cell non-keratinizing type and 15.4% in keratinizing type of squamous cell carcinoma. The overall response rate was 20.7% in squamous cell carcinoma, while 25.0% in adenocarcinoma. In 31 evaluable cases with ovarian cancer, the overall efficacy rate was 16.1%: PR was shown in 5 cases, MR in 3 cases, NC in 11 cases and PD in 12 cases. Histologically, the response rate was 16.7% in serous cystadenocarcinoma, 25.0% in endometrioid adenocarcinoma and 33.3% in undifferentiated carcinoma. No responses were observed in cases with mucinous cystadenocarcinoma, clear cell adenocarcinoma, mature cystic teratoma with malignant transformation and mesodermal mixed tumor. Some adverse effects were observed in 43.2% (32 out of 74 cases evaluated for adverse effects), but those of grade 4 were not observed. Most of them were gastro-intestinal disturbances such as diarrhea and anorexia. Diarrhea of grade 3 was observed in 12.2% and anorexia of grade 3 in 5.4%. Severe myelosuppression or hepatic toxicity was not observed. These results suggested that 5'-DFUR is a useful anticancer drug against uterine cervical cancer and ovarian cancer.