Health-related quality of life in cancer patients treated with immune checkpoint inhibitors: A systematic review on reporting of methods in randomized controlled trials

OBJECTIVE: Immune checkpoint inhibitors (ICIs) have recently shown tremendous promise in the treatment of diverse cancers. The available data suggests that ICIs are well tolerated in terms of health-related quality of life (HRQOL) compared to other anticancer therapies. However, it appears that instruments currently used to evaluate HRQOL in this context may fail to capture important symptomatology unique to ICIs. This systematic review was designed to assess the adequacy of methods used to report HRQOL in cancer patients treated with ICIs and to identify the quality of life scales used. METHOD: A systematic review was performed (systematic registration number: PROSPERO: CRD42019121427). A search of the PubMed, PsycINFO, PsycARTICLES, Psychology and Behavioral Sciences collection, and SocINDEX databases was carried out for publications in English and in French. Relevant databases were searched from the earliest records through to March 2019. Publications were selected if they reported on HRQOL in patients with cancer treated by ICIs. Risk of bias was scored using the Cochrane Collaboration bias assessment tool. RESULTS: Our search identified 144 publications between 2012 and 2019, of which 15 RCTs met the inclusion criteria. The results suggest that even though the overall reporting of HRQOL was deemed to be of good quality, the data available was marred by methodological aspects such as the lack of HRQOL research hypotheses and the lack of questionnaires validated for cancer patients treated with immunotherapy. CONCLUSION: This study provides a comprehensive analysis of the current state of the art and identifies gaps in knowledge on HRQOL analysis with respect to ICIs. It also suggests avenues for further research.