A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992).
キーワード
概要
BACKGROUND
The aim of this study is to determine efficacy and feasibility of the combination regimen irinotecan and cisplatin in patients with cisplatin advanced penile cancer.
METHODS
Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m(2)) on days 1, 8 and 15 and cisplatin (80 mg/m(2)) administered every 28 days. Patients were treated either in the neo-adjuvant setting for T3 or N1-N2 disease with a maximum of four cycles before surgery or up to eight cycles for T4 or N3 or M1 disease. The study was designed with the aim to exclude a response rate (complete response + partial response) <30% (alpha = 10%, power = 95%).
RESULTS
Twenty-eight patients were included and evaluated for toxicity, and 26 eligible patients were evaluated for response. Toxicity was acceptable with three cases of grade 3 diarrhoea and two cases of grade 4 neutropenic fever. There were eight responses (two complete response and six partial response) (30.8%, 80% confidence interval 18.8% to 45.1%): three patients undergoing histological verification after chemotherapy had no evidence of malignancy.
CONCLUSIONS
The study fails to demonstrate a response rate significantly >30%. The observation regarding M0 patients suggests to repeat this study in the neo-adjuvant setting.
