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.
J Clin Oncol
; 26(3): 421-7, 2008 Jan 20.
Article
em En
| MEDLINE
| ID: mdl-18202419
ABSTRACT
PURPOSE:
Two chemotherapy regimens for intermediate- and poor-risk metastatic nonseminomatous germ cell tumors were compared for efficacy and toxicity. PATIENTS ANDMETHODS:
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/m(2) d1-5; cisplatin 20 mg/m(2) d1-5) or four to six alternating cycles of CISCA/VB (cyclophosphamide 400 mg/m(2) d1-2, doxorubicin 35 mg/m(2) d1-2, cisplatin 100 mg/m(2) d3/vinblastine 2.5 mg/m(2) d1-5, bleomycin 25 mg/m(2) 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.
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Base de dados:
MEDLINE
Assunto principal:
Neoplasias Retroperitoneais
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Neoplasias Testiculares
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Protocolos de Quimioterapia Combinada Antineoplásica
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Neoplasias Embrionárias de Células Germinativas
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Neoplasias do Mediastino
Idioma:
En
Ano de publicação:
2008
Tipo de documento:
Article