title: Patient reported outcomes of a randomized, placebo-controlled trial of bevacizumab in the front-line treatment of ovarian cancer: a Gynecologic Oncology Group Study.
abstract: OBJECTIVE
  To analyze quality of life (QOL) in a randomized, placebo-controlled phase III trial concluding that the addition of concurrent and maintenance bevacizumab (Arm 3) to carboplatin and paclitaxel prolongs progression-free survival in front-line treatment of advanced ovarian cancer compared to chemotherapy alone (Arm 1) or chemotherapy with bevacizumab in cycles 2-6 only (Arm 2).
  
  
  METHODS
  The Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) was used to assess QOL before cycles 1, 4, 7, 13, and 21; and 6months after completing study therapy. Differences in QOL scores were assessed using a linear mixed model, adjusting for baseline score, and age. The significance level was set at 0.0167 to account for multiple comparisons.
  
  
  RESULTS
  1693 patients were queried. Arm 2 (p<0.001) and Arm 3 (p<0.001) reported lower QOL scores than those in Arm 1. The treatment differences were observed mainly at cycle 4, when the patients receiving bevacizumab (Arm 2 and Arm 3) reported 2.72 points (98.3% CI: 0.88-4.57; effect size=0.18) and 2.96 points (98.3% CI: 1.13-4.78; effect size=0.20) lower QOL respectively, than those in Arm 1. The difference in QOL scores between Arm 1 and Arm 3 remained statistically significant up to cycle 7. The percentage of patients who reported abdominal discomfort dropped over time, without significant differences among study arms.
  
  
  CONCLUSIONS
  The small QOL difference observed during chemotherapy did not persist during maintenance bevacizumab.
authors.affiliation: Creighton University School of Medicine at St. Joseph's Hospital and Medical Center, Department of Obstetrics and Gynecologic Oncology, 500 W. Thomas Road, Suite 600, Phoenix, AZ 85013, USA. Bradley.Monk@chw.edu
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Monk
authors.forename: Helen Q
authors.initials: HQ
authors.lastname: Huang
authors.forename: Robert A
authors.initials: RA
authors.lastname: Burger
authors.forename: Robert S
authors.initials: RS
authors.lastname: Mannel
authors.forename: Howard D
authors.initials: HD
authors.lastname: Homesley
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Fowler
authors.forename: Benjamin E
authors.initials: BE
authors.lastname: Greer
authors.forename: Matthew
authors.initials: M
authors.lastname: Boente
authors.forename: Sharon X
authors.initials: SX
authors.lastname: Liang
authors.forename: Lari
authors.initials: L
authors.lastname: Wenzel
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010919:Placebos; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D010919:Placebos; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel