UNASSIGNED: e14072 Background: QOL parameters are often used as endpoints in phase III trials in medical oncology. We assessed the extent to which these parameters had been used in recent studies on @entity14 and investigated the frequency and correlates of significant QOL gains. METHODS: We used the medical subject headings " @entity14 " and "drug therapy" to search PubMed for the main paper reporting phase III trials on systemic antineoplastic therapies published between 1/1998 and 12/2009 in 10 leading journals (Ann Oncol, Br J @entity5 , @entity5 , Clin @entity5 Res, Eur J @entity5 , JCO, JNCI, Lancet Oncol, Lancet and NEJM). We also searched for companion papers reporting on QOL separately. We excluded papers reporting on correlative biology or prognostic factors in isolation from the main trial results. RESULTS: We retrieved 67 trials that enrolled a total of 35,117 evaluable @entity1 in 149 trial arms. The proportion of trials mentioning QOL in the second 6-year period (28.2%) was lower than in the first period (61%; P=0.01). QOL parameters were listed as endpoints in 22 reports (33%), never as primary or co-primary endpoints. The most common instrument used for QOL assessment was QLQ C-30. Formal statistical comparisons involving QOL parameters were reported in 23/67 cases (34%), and a significant difference was found in 7/23 (30%) trials, in 5 cases favoring the experimental arm. QOL was mentioned in the abstract of 19/67 (28%) reports, in 10 cases in the conclusion. Trials with QOL gain included more @entity1 than those without (medians of 572 vs 374), but the difference was not significant. Other associations between gains in QOL and study variables will be presented. CONCLUSIONS: QOL has been formally assessed in nearly one-third of contemporary phase III trials in advanced @entity14 , but this practice seems to be declining. A significant gain in QOL has been found in almost one-third of trials in which such endpoints were analyzed.

Assessment of quality of life (QOL) in phase III trials in advanced @entity14 ( XXXX ).

@entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity1 :: ('9606', 'Species') :: ['patients'] @entity14 :: ('MESH:D015179', 'Disease') :: ['CRC', 'colorectal neoplasms']
@entity14 :: (MESH:D015179,Disease) :: ['CRC']
