Despite significant advances in treatments for renal cell carcinoma (RCC) over the past decade, health-related quality of life (HRQOL) assessments have not been updated to reflect these developments. The aim of our study was to refine assessment of HRQOL for patients with localized or metastatic RCC.
We conducted a four-phase international study (August 2022-October 2024). Phase 1 involved a patient survey identifying relevant HRQOL issues. In phase 2, an expert panel refined items, followed by patient advocate feedback in phase 3. Phase 4 harmonized items with the Functional Assessment of Chronic Illness Therapy library for consistency across RCC stages. Data analysis included descriptive statistics and qualitative analysis of the content.
Of 54 items from the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, and EuroQol Group-Five Dimension questionnaires, the metastatic RCC cohort endorsed 15 items, while the localized RCC cohort endorsed six. Expert panel review and patient advocate feedback resulted in a revised 23-item FKSI questionnaire with targeted subsets of 11 items for localized RCC and 12 items for metastatic RCC. Application of a relevance threshold of 66% ensured clinical significance but limited the sensitivity. Future studies could explore complementary approaches to refine item selection and enhance score interpretability. Study limitations include a potentially limited patient sample and reliance on patient recall of patient-reported outcomes.
We successfully developed item subsets of the FKSI-23 questionnaire that address the multifaceted impact of localized and metastatic RCC on patients' HRQOL. These two clinical settings required distinct tools for optimal measurement of HRQOL. Validation of the resulting FKSI-23 tool is under way in forthcoming clinical trials.
European urology oncology. 2025 Aug 18 [Epub ahead of print]
Cristiane D Bergerot, David Cella, Paulo G Bergerot, Daniela V Castro, Benjamin D Mercier, Elizabeth Nally, Adil A Ali, Errol J Philip, Thomas Hutson, Axel Bex, Sarah P Psutka, Brian Rini, Elizabeth R Plimack, Viktor Grünwald, Viraj Master, Laurence Albiges, Toni K Choueiri, Sumanta K Pal, Thomas Powles
Oncoclinicas&Co - Medica Scientia Innovation Research, Sao Paulo, Brazil., Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA., Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA., Barts Cancer Centre, St. Bartholomew's Hospital, London, UK., Emory University Hospital, Atlanta, GA, USA., University of California-San Francisco, San Francisco, CA, USA., Texas Tech University Health Science Center, Lubbock, TX, USA., Netherlands Cancer Institute, Amsterdam, The Netherlands., University of Washington, Seattle, WA, USA., Vanderbilt-Ingram Cancer Center, Nashville, TN, USA., Fox Chase Cancer Center, Philadelphia, PA, USA., Clinics for Medical Oncology and Urology, University Hospital Essen, Essen, Germany., Gustave Roussy Institute, Paris, France., Dana-Farber Cancer Institute, Boston, MA, USA., Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. Electronic address: ., Barts Cancer Centre, St. Bartholomew's Hospital, London, UK. Electronic address: .