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著者: C Theodore, I Skoneczna, I Bodrogi, M Leahy, J M Kerst, L Collette, K Ven, S Marréaud, R D T Oliver, EORTC Genito-Urinary Tract Cancer Group
雑誌名: Ann Oncol. 2008 Jul;19(7):1304-7. doi: 10.1093/annonc/mdn149. Epub 2008 Apr 15.
Abstract/Text
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.
PATIENTS AND 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.
CONCLUSION: 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.
PMID 18417462 Ann Oncol. 2008 Jul;19(7):1304-7. doi: 10.1093/annonc/mdn149. Epub 2008 Apr 15.
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