title: Quality of life (QOL) outcomes from a randomized trial of cisplatin versus cisplatin plus paclitaxel in advanced cervical cancer: a Gynecologic Oncology Group study.
abstract: OBJECTIVE
  Chemotherapy can profoundly affect patients' quality of life (QOL), yet few clinical trials in advanced cervical cancer have included QOL outcomes. Our purpose was to assess the impact of cisplatin (C) versus cisplatin plus paclitaxel (CP) on overall QOL and pain in cervical cancer patients.
  
  
  METHODS
  QOL was assessed using FACT-Cx, consisting of the Functional Assessment of Cancer Therapy (FACT-G) plus a cervix cancer-specific subscale, the Brief Pain Inventory-Short Form (BPI-SF), and a neurotoxicity subscale. Time points were: baseline (prior to randomization) and prior to chemotherapy cycles 2, 3, and 4.
  
  
  RESULTS
  Overall (FACT-G) scores did not differ significantly between arms at the fourth assessment (C = 70.3 (19.6); CP = 72.8 (17.4)). Scores were stable over time and considerably lower than the general population norms. The BPI-SF revealed a decline in pain scores in both arms from the first to fourth assessments. The CP arm produced a significantly higher response rate and progression-free survival (PFS) but not overall survival (OS). Greater myelosuppression was reported in the combination arm. The rate of QOL drop-out for any reason was higher for C (53%) compared to CP (38%) (P < 0.05). At the fourth time point, 60% of living patients in both arms completed a QOL assessment.
  
  
  CONCLUSIONS
  There was no significant difference in overall QOL scores between treatment arms or serially. Combined with QOL results, the significant increase in response and PFS in the CP arm and the higher drop-out rate in the C arm suggest a better outcome for the combination regimen despite its increased myelosuppression.
authors.affiliation: Psychosocial Oncology, Comprehensive Cancer Center of Wake Forest University, Department of Internal Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1082, USA. rmcquell@wfubmc.edu
authors.forename: Richard P
authors.initials: RP
authors.lastname: McQuellon
authors.forename: Howard T
authors.initials: HT
authors.lastname: Thaler
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: David H
authors.initials: DH
authors.lastname: Moore
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D011788:Quality of Life; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D017239:Paclitaxel; D002945:Cisplatin