title: Assessment of quality of life in advanced breast cancer. An overview of randomized phase III trials.
abstract: BACKGROUND
  Health-related quality of life (HRQOL) parameters are often used as end points in phase III trials in advanced breast cancer. The frequency and correlates of significant gains in HRQOL have not been assessed.
  
  
  METHODS
  To evaluate the contemporary role for HRQOL assessment in advanced breast cancer, we searched PubMed for the main and companion papers reporting the results of phase III trials on systemic antineoplastic therapies published between 1/98 and 7/09 in 11 leading journals.
  
  
  RESULTS
  The search yielded 87 trials that enrolled a total of 33,669 patients. HRQOL was mentioned/reported in the main paper in 34 trials, reported in a companion paper in one (a total of 35/87=40%), and mentioned in the abstract of the main paper in 19/34 cases (56%). There was no temporal trend for reporting on HRQOL in the two 6-year periods. Although formal statistical comparisons were reported in 31/35 cases (89%), a significant difference was found in only 4/31 (13%) trials, always favoring the experimental arm. Given the small number of studies with a significant HRQOL finding, we could not assess correlates of gain in HRQOL.
  
  
  CONCLUSIONS
  HRQOL is one of the key indicators of treatment benefit in advanced breast cancer, but contemporary systemic therapies in this setting do not appear to affect HRQOL differentially.
authors.affiliation: Regional Oncology Center of Gdansk, Ul Marii Skłodowskiej-Curie 2, 80-210 Gdańsk, Poland. krzys.adamowicz@gmail.com
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Adamowicz
authors.forename: Jacek
authors.initials: J
authors.lastname: Jassem
authors.forename: Artur
authors.initials: A
authors.lastname: Katz
authors.forename: Everardo D
authors.initials: ED
authors.lastname: Saad
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic
chemical_list: D000970:Antineoplastic Agents