Health-related quality of life in stage III-IV melanoma treated with targeted therapy or immunotherapy: A systematic review on the adequacy of reporting and clinical issues in phase III randomized controlled trials

Abstract

Cutaneous melanoma represents around over 90% of all melanoma. With more effective treatments able to extend patients' survival, health-related quality of life (HRQOL) is increasingly becoming an important endpoint in cancer clinical trials. They are often secondary outcomes measured in phase III randomized controlled trials and their implementation, collection, analysis, and reporting can be challenging methodologically. For these reasons, an increasing number of international recommendations introduced the standards regarding the conduct of HRQOL. In this systematic review, we appraise the adequacy of HRQOL reporting in phase III randomized controlled trials of stage III-IV cutaneous melanoma and the clinical issues of immunotherapy and small-molecular-targeted therapy on HRQOL. Our search strategy totally got 55 articles, and only 13 studies met all inclusion criteria. Findings suggest that most treatments did not yield significant improvements in HRQOL but kept baseline levels, accompanied by prolonged survival and acceptable toxicity. Except for some existing limitations, reporting of HRQOL has made encouraging progress during the period covered by our search, but some aspects still need further optimization.