Skip Navigation


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
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow All Versions of this Article:
19/7/1304    most recent
mdn149v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Theodore, C.
PubMed
Right arrow PubMed Citation
Right arrow Articles by Theodore, C.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 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.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?




Disclaimer:
Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.