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Randomized Trial Comparing Bleomycin/Etoposide/Cisplatin With Alternating Cisplatin/Cyclophosphamide/Doxorubicin and Vinblastine/Bleomycin Regimens of Chemotherapy for Patients With Intermediate- and Poor-Risk Metastatic Nonseminomatous Germ Cell Tumors: Genito-Urinary Group of the French Federation of Cancer Centers Trial T93MP

Stéphane Culine, Andrew Kramar, Christine Théodore, Lionel Geoffrois, Christine Chevreau, Pierre Biron, Binh Bui Nguyen, Jean-François Héron, Pierre Kerbrat, Armelle Caty, Rémy Delva, Pierre Fargeot, Karim Fizazi, Jeannine Bouzy, Jean-Pierre Droz

From the Centre Regional de Lutte contre le Cancer Val d'Aurelle, Montpellier; Institut Gustave Roussy, Villejuif; Centre Alexis Vautrin, Nancy; Institut Claudius Régaud, Toulouse; Centre Léon Bérard, Lyon; Institut Bergonié, Bordeaux; Centre François Baclesse, Caen; Centre Eugène Marquis, Rennes; Centre Oscar Lambret, Lille; Centre Eugène Papin, Angers; and the Centre Georges François, Leclerc, France

Corresponding author: Stéphane Culine, MD, PhD, Department of Medical Oncology, CRLC Val d'Aurelle, Parc Euromédecine, 34298 - Montpellier Cedex 5, France; e-mail: stculine{at}valdorel.fnclcc.fr

Purpose Two chemotherapy regimens for intermediate- and poor-risk metastatic nonseminomatous germ cell tumors were compared for efficacy and toxicity.

Patients and Methods From February 1994 to February 2000, 190 patients were randomly assigned between either four cycles of BEP (bleomycin 30 mg d1, d8, d15; etoposide 100 mg/m² d1-5; cisplatin 20 mg/m² d1-5) or four to six alternating cycles of CISCA/VB (cyclophosphamide 400 mg/m² d1-2, doxorubicin 35 mg/m² d1-2, cisplatin 100 mg/m² d3/vinblastine 2.5 mg/m² d1-5, bleomycin 25 mg/m² d1-5). Risk was initially defined according to the Institut Gustave Roussy (Villejuif, France) prognostic model based on serum alpha-fetoprotein and human chorionic gonadotropin levels only. Patients were retrospectively assigned into the International Germ Cell Consensus Classification.

Results Among 185 assessable patients, favorable responses did not differ statistically between the two arms: 49 in the CISCA/VB arm (56%; 95% CI, 45% to 66%), 57 in the BEP arm (65%; 95% CI, 55% to 75%). The CISCA/VB regimen induced more significant hematologic and mucous toxicities compared with the BEP arm. The 5-year event-free survival rates were 37% (95% CI, 27% to 47%) and 47% (95% CI, 37% to 57%) in CISCA/VB and BEP arms, respectively (hazard ratio [HR] = 0.76; 95% CI, 0.52 to 1.11; P = .15). With a median follow-up of 7.8 years, the 5-year overall survival rates were 59% (95% CI, 47% to 67%) and 69% (95% CI, 58% to 77%) in CISCA/VB and BEP arms, respectively (HR = 0.73; 95% CI, 0.46 to 1.18; P = .24).

Conclusion Because of equivalent efficacy and lesser toxicity, the standard treatment for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors remains four cycles of BEP.

Presented at the 37th Annual Meeting of the American Society of Clinical Oncology, May 12-15, 2001, San Francisco, CA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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