A late phase II study of
CPT-11, a new derivative of
camptothecin, in
uterine cervical cancer and
ovarian cancer was carried out by a cooperative study group at 26 institutions. Out of 144 patients enrolled, total cases were 110, involving 55
uterine cervical cancers and 55
ovarian cancers. In
uterine cervical cancer, 5 cases of complete response (CR) and 8 cases of partial response (PR) were observed, with a response rate of 23.6% and a CR rate of 9.1%. In
ovarian cancer, 13 cases of PR were observed, response rate was 23.6%. Both in
uterine cervical cancer and
ovarian cancer, the 95% confidence interval of response rate was 12.4-34.8%. In cases having undergone previous
chemotherapy including
platinum, derivatives, the response rate in
ovarian cancer was 23.1% (12/52). In cases of
uterine cervical cancer having previous
radiotherapy, the response rate was 26.8% (11/41). In
ovarian cancer of various histological types, a response was observed for not only
serous cystadenocarcinoma but also
mucinous cystadenocarcinoma, etc. A response was observed in distant metastatic lesions such as lung
metastasis as well as primary lesion in
uterine cervical cancer and
ovarian cancer. Major adverse reactions were
leukopenia,
nausea and
vomiting,
diarrhea and
anorexia, and these incidences (grade 2 or more) were 87.3, 60.3, 44.0 and 67.2%, respectively. Since some patients experienced severe adverse reactions, caution should be taken in treatment with
CPT-11. Besides these reactions,
alopecia was observed (33.1%), but severe adverse reactions such as nephropathy were not found. No significant difference in the efficacy and adverse reactions were observed between administration methods; A, 100 mg/m2 once weekly and B, 150 mg/m2 once every 2 weeks. Both were thought to be clinically useful. These results suggest that
CPT-11 is clinically effective against
uterine cervical cancer and
ovarian cancer.