ASCO GU 2019: Health-Related Quality of Life Reporting in Phase III Randomized Controlled Trials of Metastatic Prostate Adenocarcinoma and Urothelial Carcinoma

San Francisco, CA ( Health-related quality of life (HRQOL) reflects the patient’s subjective perception of several functional domains: physical, psychological, cognitive, social, and general well-being. HRQOL is central to assessment of efficacy and guides decision at a regulatory level, especially when drug impacts on overall survival is limited.

The aim of this study was to systematically evaluate the quality of HRQOL reporting in phase 3 randomized controlled trials (RCTs)of metastatic prostate cancer and urothelial cancers.

A systematic literature review identified phase III RCTs evaluating palliative systemic therapies for castrate sensitive or castrate resistant (excluding androgen-deprivation therapy) and metastatic urothelial carcinomas, published in English between 1985 and 2018. RCTs reporting HRQOL outcomes were scored by the Minimum Standard Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials (range 0-11). A score of above 8 could be considered as “probably robust”, and likely to have an impact on clinical decision making.

Detailed results are shown in table 1. The HRQOL populations and domains assessed by instruments used in metastatic prostate cancer and urothelial cancers RCTs are shown in table 2.
UroToday ASCOGU2019 Abstract 478 1
UroToday ASCOGU2019 Abstract 478 2

In conclusion, robust HRQOL data from phase 3 RCTs in metastatic prostate cancer and urothelial cancers remain limited, and most HRQOL reports had significant methodological shortcomings. Although disease-specific questionnaires used are validated, there is currently no culturally validated disease-specific instrument to assess HRQOL. The quality of HRQOL reporting has improved over time but needs to be better harmonized across trials.

Presented by: Di Jiang, MD, FRCPC, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada

Written By: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA