CN79 - Quality-of-Life (QoL) data published by clinical trials supporting drug approvals for renal cell carcinoma (RCC)

Background

The RCC treatment landscape is evolving in both the advanced and adjuvant settings. Most clinical trials prioritize progression free survival and overall survival as primary endpoints, often overlooking QoL assessments. However, integrating QoL data into trials can inform survivorship service enhancements for cancer patients and provide comprehensive information for treatment decisions. Our aim was to identify QoL endpoints and scales used in clinical trials supporting RCC drug approvals.

Methods

We searched for all drugs and indications approved for RCC in the United States (US), Canada (CAN), France (FRA), United Kingdom (UK), Spain (SPA), Italy (ITA), and Portugal (POR) from December 2005 to March 2024. We reviewed the trial publications and collected data on QoL measurement scales, as well as whether QoL was analysed as secondary or exploratory endpoint.

Results

Among the 20 identified approved indications, 14 (70%) were supported by trials that measured QoL of participants. Out of these, 8 (57%) conducted QoL analysis as a secondary endpoint, while 6 (43%) did it as an exploratory endpoint. The most frequent employed QoL scale was FKSI-DRS (64%, n=9), followed by QLQ-C30 (43%, n=6) and EQ-5D-3L (36%, n=5). Other utilised scales were EQ-5D (21%, n=3), FKSI-15 (21%, n=3), FKSI-19 (21%, n=3), EQ-VAS (14%, n=2), FACT-G (14%, n=2), FKSI-10 (7%, n=1), and FACT-G PWB (7%, n=1). Notably, out of the 14 indications with QoL data, 13 (93%) used 2 or more scales.

Conclusions

Not all the identified approved indications have published QoL data. Of those that have, roughly half have published the data as a secondary endpoint. The 10 QoL scales were used in different combinations in every study, demonstrating no consistency between trials. Without consistent and equitable measurements of QoL data across the RCC treatment landscape, how can patients be fully informed of the impact treatments may have on their QoL? In future, comparing the parameters each trial used to identify change in QoL status, and examining how many trials demonstrated sustained/improved QoL compared to Standard of Care may be useful.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

R.E. Seadon: Financial Interests, Other, Travel, Accommodations and Expenses: Ipsen. J.C. Tapia: Other, Conference Registration Fee, Travel, Accommodations and Expenses: Merck, Pfizer, Roche, MSD, EUSA Pharma UK. D. Matthews: Financial Interests, Speaker’s Bureau: Astellas, Janssen. J. Gavira-Diaz: Financial Interests, Speaker’s Bureau: Astellas, LEO Pharma; Financial Interests, Other, Travel, Accommodations and Expenses: Ipsen, BMS, Novartis, Roche. M. Santoni: Financial Interests, Research Funding: Janssen, Bristol Myers Squibb, Ipsen, MSD, Astellas, A.A.A., Bayer. M.N. Young: Financial Interests, Personal, Invited Speaker, Invited speaker to “First Thoughts in renal cell carcinoma” conference in June 2023: Eisai. R. Flippot: Financial Interests, Institutional, Invited Speaker: Ipsen, Pfizer; Financial Interests, Institutional, Advisory Board: MSD, Eisai, Astellas, Bayer, Johnson & Johnson, Merck Serono; Financial Interests, Personal, Other, Travel Expenses: Bristol Myers Squibb; Financial Interests, Institutional, Coordinating PI: Bayer. G. Anguera: Financial Interests, Speaker’s Bureau: Astellas Pharma, Ipsen, Bristol Myers Squibb, Merck/Pfizer, Leo Pharma; Financial Interests, Advisory Role: Merck; Financial Interests, Other, Travel, Accommodations, Expenses: Merck, Ipsen, Bristol Myers Squibb. R. Frazer: Financial Interests, Speaker, Consultant, Advisor: BMS, Eisai, Ewopharma, Ipsen, Merck, MSD, Novartis, Pfizer, Pierre Fabre, Recordati, Roche, Sanofi. J.P. Maroto Rey: Financial Interests, Personal, Advisory Board, Participation in Ad Boards: Bayer; Financial Interests, Personal, Advisory Board, Participation in Ad Boards: Astellas, Merck, Pfizer, MSD; Financial Interests, Personal, Invited Speaker: Janssen; Non-Financial Interests, Principal Investigator, Collaboration as PI in trials: AstraZeneca. All other authors have declared no conflicts of interest.