Phase II study of a combination of cyclophosphamide, adriamycin and cisplatin in advanced Fallopian tube carcinoma - An EORTC Gynecological Cancer Group Study

Objective: To investigate the clinical activity and toxicity of a combinati on chemotherapy consisting of cyclophosphamide (C), adriamycin (A) and cisp latin (P) for patients with primary adenocarcinoma of the Fallopian tube ha ving FIGO stage III-IV disease. Methods: The CAP-regimen consisted of cyclophosphamide 600 mg/m(2), adriamy cin 45 mg/m(2), and cisplatin 50 mg/m(2) administered intravenously on day one every 28 days. Results: Twenty-four eligible patients with histologic ally-confirmed Fallo pian tube adenocarcinoma were entered in the trial. Fourteen patients had F IGO stage III, and ten had stage IV disease. The median number of CAP cycle s was six. Ten patients had a complete and six had a partial response (resp onse rate: 67%, 95% confidence limits: 45-84%). WHO grade III-IV side-effec ts included haematological toxicity, nausea/vomiting and alopecia. Furtherm ore, mild signs of cisplatin-related peripheral neurotoxicity were observed . At a median follow-up of 40 months, nine patients were alive and 15 had d ied due to malignant disease. The median time to progression was 13 months for all patients. The median overall survival was 24 months and the 1-, 3- and 5-year survival and their 95% confidence limits were 73% (54-92%), 25% (4-46%) and 19% (0-38%), respectively. Conclusion: The present data confirm the therapeutic activity of the CAP-re gimen in primary Fallopian tube adenocarcinoma. The response rate is modera te and the toxicity profile is acceptable.