Assessment of quality of life in advanced breast cancer. An overview of randomized phase III trials

BackgroundHealth-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.MethodsTo 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.ResultsThe 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.ConclusionsHRQOL 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.