title: Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study.
abstract: OBJECTIVE
  In randomized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer. Although in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population.
  
  
  METHODS
  Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 (arm I), or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m2 over 3 hours (arm II).
  
  
  RESULTS
  Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression-free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02).
  
  
  CONCLUSIONS
  In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel.
authors.affiliation: Medical Science Department, Fox Chase Cancer Center, Philadelphia, PA, USA.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Ozols
authors.forename: Brian N
authors.initials: BN
authors.lastname: Bundy
authors.forename: Benjamin E
authors.initials: BE
authors.lastname: Greer
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Fowler
authors.forename: Daniel
authors.initials: D
authors.lastname: Clarke-Pearson
authors.forename: Robert A
authors.initials: RA
authors.lastname: Burger
authors.forename: Robert S
authors.initials: RS
authors.lastname: Mannel
authors.forename: Koen
authors.initials: K
authors.lastname: DeGeest
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Hartenbach
authors.forename: Rebecca
authors.initials: R
authors.lastname: Baergen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage*; D016016:Proportional Hazards Models; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin