[Phase II study of carboplatin in cervical carcinoma]

A phase II multi-center study of carboplatin for cervical carcinoma was carried out in 22 institutes throughout Japan. The patients registered consisted of 40 women with 39 cervical carcinomas and an endometrial carcinoma, of whom 31 were evaluable. Carboplatin was administered intravenously every 4 weeks at a dose of 400 mg/m2, in cases with no prior therapies and/or P.S. 0-1, and 300 mg/m2 in cases with prior therapies and/or P.S. 2-3. The overall response rate of 31 evaluable cases was 19.4% with 2 cases of CR and 4 cases of PR. The response rates by histological classification were 18.5% (5/27) for squamous cell carcinoma and 25.0% (1/4) for adenocarcinoma. Response rates analysed by lesion sites were 12.5% for primary tumors, 30.0% for local lesions and 20.0% for metastases. The response rate among patients without prior therapies was 14.3%, while those for patients with prior radiotherapy and for prior radiotherapy and chemotherapy were 33.3% and 13.3%, respectively. Major adverse effects observed were nausea and/or vomiting (52.9%), anorexia (44.1%) and malaise (35.3%). Hematologically, thrombocytopenia, leukopenia and anemia were frequently observed (52.9%, 35.3% and 32.4%, respectively). As for renal toxicity, elevation of BUN (2.9%) or serum creatinine (2.9%) and the decrease of creatinine clearance (14.3%) were observed, but they were mild, and tolerable. These results suggest that carboplatin is one of the most useful drugs against cervical carcinoma.