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)
| Autor: | J. Bouzy, P. Biron, Remy Delva, Christine Theodore, A. Caty, P. Kerbrat, Lionnel Geoffrois, J. Peny, Christine Chevreau, Stéphane Culine, Andrew Kramar, J.P. Droz, N.B. Bui, Karim Fizazi |
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| Rok vydání: | 2007 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Time Factors Adolescent law.invention Institut Gustave Roussy Bleomycin Randomized controlled trial Testicular Neoplasms law Risk Factors Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Neoplasm Metastasis Survival rate Survival analysis Etoposide business.industry Hematology Middle Aged Neoplasms Germ Cell and Embryonal medicine.disease Chemotherapy regimen Survival Analysis Surgery Treatment Outcome Germ cell tumors Cisplatin business medicine.drug Follow-Up Studies |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 18(5) |
| ISSN: | 0923-7534 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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