title: Health-related quality of life outcomes of docetaxel/carboplatin combination therapy vs. sequential therapy with docetaxel then carboplatin in patients with relapsed, platinum-sensitive ovarian cancer: results from a randomized clinical trial.
abstract: OBJECTIVE
  A phase II clinical trial compared docetaxel in combination with carboplatin to sequential single agent docetaxel followed by carboplatin for treatment of recurrent platinum-sensitive ovarian, peritoneal, or tubal cancer. This manuscript reports prospectively collected health-related quality of life (HRQL).
  
  
  METHODS
  Participants were randomized to either weekly docetaxel 30 mg/m(2)/days 1 and 8 and carboplatin AUC 6/day 1 every 3 weeks (cDC) or docetaxel 30 mg/m(2)/days 1 and 8, repeated every 3 weeks for 6 cycles followed by carboplatin AUC 6/day 1 every 3 weeks for 6 cycles or until disease progression (sDC). The primary HRQL endpoint was the trial outcome index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, and was assessed as an intent-to-treat analysis. The secondary HRQL endpoints included the FACT-O total score, the FACT-General, and several domain scores of the FACT-O instrument (physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and the ovarian cancer specific (OCS) module). The FACT-O was administered at randomization, prior to each of 6 cycles of treatment, and at study endpoint.
  
  
  RESULTS
  One hundred forty-eight participants were randomized to each group. Sequential docetaxel followed by carboplatin (sDC) was associated with significant improvements in the FACT-O TOI (p=0.013), FACT-O total score (p=0.033), and OCS (p=0.029) compared to the combination docetaxel and carboplatin group (cDC).
  
  
  CONCLUSIONS
  Sequential single agent docetaxel followed by carboplatin is associated with improved HRQL when compared to cDC. The improved progression-free survival observed with cDC should be weighed against lower quality of life during treatment.
authors.affiliation: Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA.
authors.forename: Robin
authors.initials: R
authors.lastname: Pokrzywinski
authors.forename: Angeles Alvarez
authors.initials: AA
authors.lastname: Secord
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Havrilesky
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: 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: Dennis A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D012720:Severity of Illness Index; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin