title: A multicenter, randomized, phase 2 clinical trial to evaluate the efficacy and safety of combination docetaxel and carboplatin and sequential therapy with docetaxel then carboplatin in patients with recurrent platinum-sensitive ovarian cancer.
abstract: BACKGROUND
  The aim of this randomized clinical trial was to evaluate the efficacy and safety of combination (cDC) and sequential (sDC) weekly docetaxel and carboplatin in women with recurrent platinum-sensitive epithelial ovarian cancer (EOC).
  
  
  METHODS
  Participants were randomized to either weekly docetaxel 30 mg/m(2) on days 1 and 8 and carboplatin area under the curve (AUC) = 6 on day 1, every 3 weeks or docetaxel 30 mg/m(2) on days 1 and 8, every 3 weeks for 6 cycles followed by carboplatin AUC = 6 on day 1, every 3 weeks for 6 cycles or until disease progression. The primary endpoint was measurable progression-free survival (PFS).
  
  
  RESULTS
  Between January 2004 and March 2007, 150 participants were enrolled. The response rate was 55.4% and 43.2% for those treated with cDC and sDC, respectively. The median PFS was 13.7 months (95% confidence interval [CI], 9.9-16.8) for cDC and 8.4 months (95% CI, 7.1-11.0) for sDC. On the basis of an exploratory analysis, patients treated with sDC were at a 62% increased risk of disease progression compared to those treated with cDC (hazard ratio = 1.62; 95% CI, 1.08-2.45; P = .02). The median overall survival time was similar in both groups (33.2 and 30.1 months, P = .2). The incidence of grade 2 or 3 neurotoxicity and grade 3 or 4 neutropenia was higher with cDC than with sDC (11.7% vs 8.5%; 36.8% vs 11.3%). The sDC group demonstrated significant improvements in the Functional Assessment for Cancer Therapy-Ovarian, Quality of Life Trial Outcome Index scores compared with the combination cohort (P = .013).
  
  
  CONCLUSIONS
  Both cDC and sDC regimens have activity in recurrent platinum-sensitive EOC with acceptable toxicity profiles. The cDC regimen may provide a PFS advantage over sDC.
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina 27710, USA. secor002@mc.duke.edu
authors.forename: Angeles
authors.initials: A
authors.lastname: Alvarez Secord
authors.forename: Andrew
authors.initials: A
authors.lastname: Berchuck
authors.forename: Robert V
authors.initials: RV
authors.lastname: Higgins
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Nycum
authors.forename: Matthew F
authors.initials: MF
authors.lastname: Kohler
authors.forename: Larry E
authors.initials: LE
authors.lastname: Puls
authors.forename: Robert W
authors.initials: RW
authors.lastname: Holloway
authors.forename: George S
authors.initials: GS
authors.lastname: Lewandowski
authors.forename: Fidel A
authors.initials: FA
authors.lastname: Valea
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Havrilesky
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000401:mortality; D010984:Platinum / Q000627:therapeutic use; D011788:Quality of Life; D012008:Recurrence; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D010984:Platinum; D016190:Carboplatin