title: 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.
abstract: OBJECTIVE
  Two chemotherapy regimens for intermediate- and poor-risk metastatic nonseminomatous germ cell tumors were compared for efficacy and toxicity.
  
  
  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/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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Centre Regional de Lutte contre le Cancer Val d'Aurelle, Montpellier, France. stculine@valdorel.fnclcc.fr
authors.forename: Stéphane
authors.initials: S
authors.lastname: Culine
authors.forename: Andrew
authors.initials: A
authors.lastname: Kramar
authors.forename: Christine
authors.initials: C
authors.lastname: Théodore
authors.forename: Lionel
authors.initials: L
authors.lastname: Geoffrois
authors.forename: Christine
authors.initials: C
authors.lastname: Chevreau
authors.forename: Pierre
authors.initials: P
authors.lastname: Biron
authors.forename: Binh Bui
authors.initials: BB
authors.lastname: Nguyen
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Héron
authors.forename: Pierre
authors.initials: P
authors.lastname: Kerbrat
authors.forename: Armelle
authors.initials: A
authors.lastname: Caty
authors.forename: Rémy
authors.initials: R
authors.lastname: Delva
authors.forename: Pierre
authors.initials: P
authors.lastname: Fargeot
authors.forename: Karim
authors.initials: K
authors.lastname: Fizazi
authors.forename: Jeannine
authors.initials: J
authors.lastname: Bouzy
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Droz
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000627:therapeutic use; D002945:Cisplatin / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D005047:Etoposide / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008479:Mediastinal Neoplasms / Q000188:drug therapy*; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy*; D011379:Prognosis; D012186:Retroperitoneal Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D013736:Testicular Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome; D014747:Vinblastine / Q000627:therapeutic use
chemical_list: D001761:Bleomycin; D014747:Vinblastine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D002945:Cisplatin