Health-related quality of life assessment and reported outcomes in leukaemia randomised controlled trials - a systematic review to evaluate the added value in supporting clinical decision making.

Health-related quality of life (HRQOL) is increasingly reported as an important outcome in cancer clinical trials. However, very little evidence exists on the impact of such evaluation in randomised controlled trials (RCTs) of leukaemia patients. A systematic search of the literature from 1980 to 2007 was undertaken and studies were identified and evaluated independently, according to a pre-defined coding scheme, by three reviewers. Both HRQOL outcomes and traditional clinical reported outcomes were systematically analysed to evaluate their consistency and their relevance for supporting clinical decision making. Nine RCTs were identified, involving 3838 patients overall. There were four RCTs involving acute myeloid leukaemia patients (AML), three with chronic myeloid leukaemia (CML) and two with chronic lymphocytic leukaemia (CLL). Six studies were published after 2000 and provided fairly robust methodological quality. Imatinib greatly improved HRQOL compared to interferon based treatments in CML patients and fludarabine plus cyclophosphamide does not seem to have a deleterious impact on patient's HRQOL when compared to fludarabine alone or chlorambucil in CLL patients. This study revealed the paucity of HRQOL research in leukaemia patients. Nonetheless, HRQOL assessment is feasible in RCTs and has the great potential of providing valuable outcomes to further support clinical decision making.