TY - JOUR
T1 - 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
T2 - Genito-Urinary Group of the French Federation of Cancer Centers Trial T93MP
AU - Culine, Stéphane
AU - Kramar, Andrew
AU - Théodore, Christine
AU - Geoffrois, Lionel
AU - Chevreau, Christine
AU - Biron, Pierre
AU - Nguyen, Binh Bui
AU - Héron, Jean François
AU - Kerbrat, Pierre
AU - Caty, Armelle
AU - Delva, Rémy
AU - Fargeot, Pierre
AU - Fizazi, Karim
AU - Bouzy, Jeannine
AU - Droz, Jean Pierre
PY - 2008/1/20
Y1 - 2008/1/20
N2 - 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/m 2 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.
AB - 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/m 2 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.
UR - http://www.scopus.com/inward/record.url?scp=38649104783&partnerID=8YFLogxK
U2 - 10.1200/JCO.2007.13.8461
DO - 10.1200/JCO.2007.13.8461
M3 - Article
C2 - 18202419
AN - SCOPUS:38649104783
SN - 0732-183X
VL - 26
SP - 421
EP - 427
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 3
ER -