title: Standard chemotherapy with or without bevacizumab in advanced ovarian cancer: quality-of-life outcomes from the International Collaboration on Ovarian Neoplasms (ICON7) phase 3 randomised trial.
abstract: BACKGROUND
  In the Gynecologic Cancer Intergroup International Collaboration on Ovarian Neoplasms 7 (ICON7) trial, bevacizumab improved progression-free survival in patients with ovarian cancer when used in combination with first-line chemotherapy and as a single-drug continuation treatment for 18 cycles. In a preliminary analysis of a high-risk subset of patients, there was also an improvement in overall survival. This study aims to describe the health-related quality-of-life (QoL) outcomes from ICON7.
  
  
  METHODS
  ICON7 is a randomised, multicentre, open-label phase 3 trial. Between Dec 18, 2006, and Feb 16, 2009, after a surgical procedure aiming to debulk the disease, women with International Federation of Gynecology and Obstetrics (FIGO) high-risk stage I-IV epithelial ovarian cancer were randomly allocated (1:1) by computer program and block randomisation to receive either six cycles of standard chemotherapy (total 18 weeks) with carboplatin (area under the curve 5 or 6) and paclitaxel (175 mg/m(2)) alone or with bevacizumab (7·5 mg/kg) given intravenously with chemotherapy and continued as a single drug thereafter (total 54 weeks). The primary QoL endpoint was global QoL from the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire-core 30 at week 54, analysed by ANOVA and adjusted for baseline score. Analyses were by intention to treat. The ICON7 trial has completed recruitment and remains in follow-up. This study is registered, number ISRCTN91273375.
  
  
  RESULTS
  764 women were randomly assigned to the standard chemotherapy group and 764 to the bevacizumab group. At baseline, 684 (90%) of women in the standard chemotherapy group and 691 (90%) of those in the bevacizumab group had completed QoL questionnaires. At week 54, 502 (66%) women in the bevacizumab group and 388 (51%) women in the standard chemotherapy group provided QoL data. Overall, the mean global QoL score improved during chemotherapy by 7·2 points (SD 24·4) when analysed for all women with data at baseline and week 18. The mean global QoL score at 54 weeks was higher in the standard chemotherapy group than in the bevacizumab group (76·1 [SD 18·2] vs 69·7 [19·1] points; difference 6·4 points, 95% CI 3·7-9·0, p<0·0001).
  
  
  CONCLUSIONS
  Bevacizumab continuation treatment seems to be associated with a small but clinically significant decrement in QoL compared with standard treatment for women with ovarian cancer. The trade-off between the prolongation of progression-free survival and the quality of that period of time needs to be considered in clinical practice when making treatment decisions.
  
  
  BACKGROUND
  Roche and the National Institute for Health Research through the UK National Cancer Research Network.
authors: Leeds Institute of Molecular Medicine, University of Leeds, St James's Institute of Oncology, Leeds, UK. Electronic address: d.p.stark@leeds.ac.uk.
authors: Dan
authors: D
authors: Stark
authors: Matthew
authors: M
authors: Nankivell
authors: Eric
authors: E
authors: Pujade-Lauraine
authors: Gunnar
authors: G
authors: Kristensen
authors: Lorraine
authors: L
authors: Elit
authors: Martin
authors: M
authors: Stockler
authors: Felix
authors: F
authors: Hilpert
authors: Andrés
authors: A
authors: Cervantes
authors: Julia
authors: J
authors: Brown
authors: Anne
authors: A
authors: Lanceley
authors: Galina
authors: G
authors: Velikova
authors: Eduardo
authors: E
authors: Sabate
authors: Jacobus
authors: J
authors: Pfisterer
authors: Mark S
authors: MS
authors: Carey
authors: Philip
authors: P
authors: Beale
authors: Wendi
authors: W
authors: Qian
authors: Ann Marie
authors: AM
authors: Swart
authors: Amit
authors: A
authors: Oza
authors: Tim
authors: T
authors: Perren
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D000068258:Bevacizumab; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab