Inadequate health-related quality of life assessment and reporting in phase III clinical trials of immune checkpoint inhibitors in solid cancers: A systematic review

We systematically reviewed QoL assessment and reporting in RCTs of immune checkpoint inhibitors (ICIs) in solid cancers published between 2013 and 2021. None of the 106 eligible trials included QoL among primary endpoints. QoL results were non-disclosed in 83/106 (78.3%) primary publications. QoL assessment was disclosed exclusively in study protocol and not in methods of the manuscript in 48.5% of publications. In 27.8% of articles, QoL assessment was disclosed in the methods but non-reported among the results. Only in 44.3% of trials missing QoL results in primary manuscripts, QoL data were reported in a secondary publication. A relevant delay occurred in secondary publications, with a median time to secondary articles with QoL results of 33.6 months. Our analysis revealed a significant underreporting of QoL in RCTs of ICIs in solid cancers. Altogether, absent or delayed disclosure of QoL results affect a complete evaluation of clinical benefit of new anticancer treatments.