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Annals of Oncology Advance Access originally published online on March 9, 2007
Annals of Oncology 2007 18(5):917-924; doi:10.1093/annonc/mdm062
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© 2007 European Society for Medical Oncology

urogenital tumors

Refining the optimal chemotherapy regimen for good-risk metastatic nonseminomatous germ-cell tumors: a randomized trial of the Genito-Urinary Group of the French Federation of Cancer Centers (GETUG T93BP)

S Culine1,*, P Kerbrat2, A Kramar1, C Théodore3, C Chevreau4, L Geoffrois5, NB Bui6, J Pény7, A Caty8, R Delva9, P Biron10, K Fizazi3, J Bouzy3 and JP Droz10

1 CRLC Val d'Aurelle, Montpellier
2 Centre Eugène Marquis, Rennes
3 Institut Gustave Roussy, Villejuif
4 Institut Claudius Régaud, Toulouse
5 Centre Alexis Vautrin, Nancy
6 Institut Bergonié, Bordeaux
7 Centre François Baclesse, Caen
8 Centre Oscar Lambret, Lille
9 Centre Eugène Papin, Angers
10 Centre Léon Bérard, Lyon, France

* Correspondence to: Dr S. Culine, Department of Medical Oncology, CRLC Val d'Aurelle, Parc Euromédecine, 34298 Montpellier Cedex 5, France. Tel: +33-467613152; Fax: +33-467613022; E-mail: stculine{at}valdorel.fnclcc.fr

Background: High cure rates are expected in good-risk metastatic nonseminomatous germ-cell tumor (NSGCT) patients with bleomycin, etoposide and cisplatin.

Patients and methods: Patients received either three cycles of BE500P or four cycles of E500P every 3 weeks. Disease was defined according to the Institut Gustave Roussy prognostic model. Patients were retrospectively assigned into the International Germ Cell Cancer Collaborative Group (IGCCCG) classification. A sample size of 250 patients was necessary for an expected favorable response rate (primary end point) of 90% and not more than a 10% difference between the two arms.

Results: Among 257 assessable patients, 124 and 122 patients achieved a favorable response in the 3BE500P and 4E500P arms, respectively (P = 0.34). Median follow-up was 53 months. The 4-year event-free survival rates were 91% and 86%, respectively (P = 0.135). The 4-year overall survival rates were not significantly different [five deaths versus 12 deaths, respectively (P = 0.096)]. Similar nonsignificant trends were observed in good IGCCCG prognosis patients.

Conclusions: Both regimens produced similar results in terms of favorable response rates. As the trial was underpowered for survival analyses, conclusive data would require a larger randomized trial. Unless such a study is done, 3BE500P is the treatment of choice for metastatic NSGCT patients.

Key words: chemotherapy, good-risk, testis cancer, germ cell cancer

Received for publication October 28, 2006. Revision received January 18, 2007. Accepted for publication January 23, 2007.


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