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 T9313P).
Fiche publication
Date publication
mai 2007
Auteurs
Membres identifiés du Cancéropôle Est :
Dr GEOFFROIS Lionnel
Tous les auteurs :
Culine S, Kerbrat P, Kramar A, Theodore C, ChevreauU C, Geoffrois L, Bui NB, Peny J, Caty A, Delva R, Biron P, Fizazi K, Bouzy J, Droz JP
Lien Pubmed
Résumé
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 3BE(500)P and 4E(500)P 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.
Référence
Ann Oncol. 2007 May;18(5):917-24