Abstract 733P
Background
Quality of life (QoL) assessment is important to evaluate treatments benefits/risks but, often, it is not included among primary/secondary endpoints in clinical trials (CT) on renal cell carcinoma (RCC). QoL measures are interpreted in various ways. Our aim was to describe the assessment and reporting of QoL measures in RCC CT.
Methods
We performed a literature search of primary phase II and III CT in RCC published between 2010 and 2020 by 7 major scientific journals. Data regarding the presence of QoL among secondary and exploratory endpoints, different assessment tools, methods of analysis were extracted. Secondary publications reporting QoL results were searched.
Results
25 publications were included (5 in adjuvant and 20 in metastatic setting). In 10/25 (40%) publications, QoL was not listed among the endpoints. Of these, 7 trials were in first-line setting, 1 in second line, 1 in the perioperative setting, 3 in the adjuvant setting. In 5/25 (20%) publications, QoL was listed as an exploratory endpoint and, among these, 2 were first-, 1 first/second-, 2 second/later-lines. In 10/25 (32%) publications, QoL was a secondary endpoint and, among these, 2 were first-, 2 first/second-, 1 second-, 1 third-line, 2 adjuvant trials. QoL results were reported in the primary publication in 12 (48%) cases and in 5 (20%) they were object of a secondary publications. Median time to secondary publications was 11 months (range 8-30). For trials including QoL among endpoints but not reporting it in the primary publication, the probability of secondary publication was 5%, 15%, 25%, and 33% after 6 months, 1, 2 and 3 years, respectively. Most common tools for QoL assessment were FKSI-15/-19 (8, 32%), FKSI-DRS (7, 28%), and EQ-5D (6, 24%). FKSI scales are questionnaires focused on kidney cancer patients.
Conclusions
There is still a large percentage of studies without QoL among the endpoints. Secondary publications dedicated to QoL are present in a minority of cases. QoL evaluation is heterogeneous. Correlation between treatment toxicities and QoL are of pivotal importance for clinical decision making. There is a need to implement QoL inclusion among trials endpoints and to better homologate its definition.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.