title: Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme: North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 Trials.
abstract: OBJECTIVE
  In patients with newly diagnosed glioblastoma multiforme, to determine whether cisplatin plus carmustine (BCNU) administered before and concurrently with radiation therapy (RT) improves survival compared with BCNU and RT and whether survival using accelerated RT (ART) is equivalent to survival using standard RT (SRT).
  
  
  METHODS
  After surgery, patients were stratified by age, performance score, extent of surgical resection, and histology (glioblastoma v gliosarcoma) and then randomly assigned to arm A (BCNU plus SRT), arm B (BCNU plus ART), arm C (cisplatin plus BCNU plus SRT), or arm D (cisplatin plus BCNU plus ART).
  
  
  RESULTS
  Four hundred fifty-one patients were randomly assigned, and 401 were eligible. Frequent toxicities included myelosuppression, vomiting, sensory neuropathy, and ototoxicity and were worse with cisplatin. There was no difference in toxicity between SRT and ART. Median survival times and 2-year survival rates for patients who received BCNU plus RT (arms A and B) compared with cisplatin, BCNU, and RT (arms C and D) were 10.1 v 11.5 months, respectively, and 11.5% v 13.7%, respectively (P = .19). Median survival times and 2-year survival rates for patients who received SRT (arms A and C) compared with ART (arms B and D) were 11.2 v 10.5 months, respectively, and 13.8% v 11.4%, respectively (P = .33).
  
  
  CONCLUSIONS
  Cisplatin administered concurrently with BCNU and RT resulted in more toxicity but provided no significant improvement in survival. SRT and ART produced similar toxicity and survival.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. buckner.jan@mayo.edu
authors.forename: Jan C
authors.initials: JC
authors.lastname: Buckner
authors.forename: Karla V
authors.initials: KV
authors.lastname: Ballman
authors.forename: John C
authors.initials: JC
authors.lastname: Michalak
authors.forename: Gary V
authors.initials: GV
authors.lastname: Burton
authors.forename: Terrence L
authors.initials: TL
authors.lastname: Cascino
authors.forename: Paula J
authors.initials: PJ
authors.lastname: Schomberg
authors.forename: Roland B
authors.initials: RB
authors.lastname: Hawkins
authors.forename: Bernd W
authors.initials: BW
authors.lastname: Scheithauer
authors.forename: Howard M
authors.initials: HM
authors.lastname: Sandler
authors.forename: Randolph S
authors.initials: RS
authors.lastname: Marks
authors.forename: Judith R
authors.initials: JR
authors.lastname: O'Fallon
mesh_terms: D000328:Adult; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage* / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D016896:Treatment Outcome; D014481:United States
chemical_list: D018906:Antineoplastic Agents, Alkylating; D002945:Cisplatin; D002330:Carmustine