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Annals of Oncology Advance Access originally published online on April 15, 2008
Annals of Oncology 2008 19(7):1304-1307; doi:10.1093/annonc/mdn149
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

urogenital tumors

A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992)

C. Theodore1,*, I. Skoneczna2, I. Bodrogi3, M. Leahy4, J. M. Kerst5, L. Collette6, K. Ven6, S. Marréaud6, R. D. T. Oliver7 and for the EORTC Genito-Urinary Tract Cancer Group

1 Department of Medicine, Institut Gustave Roussy, Villejuif, France
2 Department of Urology, Maria Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland
3 Department of Medicine, National Institute of Oncology, Budapest, Hungary
4 Department of Oncology, St James’s University Hospital, Leeds, UK
5 Department of Oncology, Netherlands Cancer Institute/Antoni Van Leeuwenhoek Hospital, Amsterdam, The Netherlands
6 Statistic Department, European Organization for Research and Treatment of Cancer, Brussels, Belgium
7 Department of Oncology, St Bartholomews, London, UK

* Correspondence to: Dr C. Theodore, Department of Medicine, Institut Gustave Roussy—Medecinerue camille desmoulins none, Villejuif 4800, France. Tel: +33-142114898; Fax: +33-142115238; E-mail: c.theodore{at}hopital-foch.org

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/m2) on days 1, 8 and 15 and cisplatin (80mg/m2) 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.

Key words: advanced penile cancer, chemotherapy, cisplatin, irinotecan

Received for publication February 24, 2008. Accepted for publication March 5, 2008.


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