title: Improved therapeutic index of carboplatin plus cyclophosphamide versus cisplatin plus cyclophosphamide: final report by the Southwest Oncology Group of a phase III randomized trial in stages III and IV ovarian cancer.
abstract: OBJECTIVE
  To compare cisplatin-cyclophosphamide versus carboplatin-cyclophosphamide as primary chemotherapy for stage III (suboptimal) and stage IV ovarian cancer.
  
  
  METHODS
  Three hundred forty-two patients were randomly assigned to treatment with six courses of intravenous (i.v.) cisplatin 100 mg/m2 plus i.v. cyclophosphamide 600 mg/m2, or i.v. carboplatin 300 mg/m2 plus i.v. cyclophosphamide 600 mg/m2.
  
  
  RESULTS
  The estimated median survivals were 17.4 and 20.0 months for the cisplatin and carboplatin study arms, respectively. The null hypothesis of a 30% survival superiority with the cisplatin arm was rejected at the P = .02 level. Clinical response rates were 52% for the cisplatin arm and 61% for the carboplatin arm. Pathologic complete response rates were similar for both study arms. There was less thrombocytopenia on the cisplatin arm (P less than .001); however, there was less nausea and emesis (P less than or equal to .001 for courses 1 to 5), renal toxicity (P less than .001), anemia (P = .01), hearing loss (P less than .001), tinnitus (P = .01), neuromuscular toxicities (P = .001), and alopecia (P less than .001) on the carboplatin arm.
  
  
  CONCLUSIONS
  Carboplatin-cyclophosphamide proved to have a significantly better therapeutic index than cisplatin-cyclophosphamide in patients with stage III (suboptimal) and stage IV ovarian cancer.
authors.affiliation: University of Arizona Cancer Center, Tucson.
authors.forename: D S
authors.initials: DS
authors.lastname: Alberts
authors.forename: S
authors.initials: S
authors.lastname: Green
authors.forename: E V
authors.initials: EV
authors.lastname: Hannigan
authors.forename: R
authors.initials: R
authors.lastname: O'Toole
authors.forename: D
authors.initials: D
authors.lastname: Stock-Novack
authors.forename: P
authors.initials: P
authors.lastname: Anderson
authors.forename: E A
authors.initials: EA
authors.lastname: Surwit
authors.forename: V K
authors.initials: VK
authors.lastname: Malvlya
authors.forename: W A
authors.initials: WA
authors.lastname: Nahhas
authors.forename: C J
authors.initials: CJ
authors.lastname: Jolles
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D012086:Reoperation; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D016190:Carboplatin; D002945:Cisplatin