2: Relevance of items in the FACT Kidney Cancer Symptom Inventory-19 (FKSI-19): Results of a patient survey

JoAnn Hsu, BS; Thomas Hutson, DO, PharmD; Paulo Bergerot, MD; Thomas Powles, MD; Brian Rini, MD; Toni Choueiri, MD; Sumanta Pal, MD, FASCO; Sarah Psutka, MD, MS; Elizabeth Plimack, MD, MS; Augusto de Andrade Mota, MD, PhD; João de Matos Neto, MD, PhD; Viktor Grünwald, MD, PhD; Axel Bex, MD, PhD; Viraj Master, MD, PhD; Laurence Albiges, MD, PhD; Daniela Castro, MS; Errol Philip, PhD; Jasnoor Malhotra

Background
Health-related quality of life (HRQoL) has been evaluated in several randomized phase III trials, including in metastatic renal cell carcinoma (mRCC). At present, we lack consensus regarding which HRQoL assessment tool should be utilized and preferred. This survey study sought to evaluate the patient-reported relevance of the individual items of the FKSI-19 in this patient population.

Methods
Eligible patients had been diagnosed with mRCC and were receiving immunotherapy and/or targeted therapy. In addition to capturing demographic characteristics, patients were presented with the elements of the FKSI-19 and asked to rate their relevance to their overall HRQoL on a 5 point Likert scale (0-2 irrelevant, 3-5 relevant), including one open-ended question querying topics. Questions were identified as possibly irrelevant if the proportion in group (a) constituted > 80% of the responses within the cohort. Descriptive statistics were used. Open-ended question was analyzed by 2 independent reviewers (CB, PB) and categorized into descriptive categories.

Results
Among 47 patients with mRCC from Brazil and the US, the median age was 64 years old; most were male (82%) and were receiving treatment with targeted therapy (36%) or immunotherapy (34%). The FKSI-19 items rated as most relevant for HRQoL included fatigue/lack of energy (57% and 55%), treatment side effects (55%), and unintended weight loss (51%). In contrast, blood in urine (97%), fevers (95%) and nausea (93%) were rated as irrelevant with regard to HRQOL. No significant differences were observed between the responses of patients receiving targeted therapy versus immunotherapy. Patients identified several areas worthy of greater attention, including emotional symptoms, social support, ability to exercise and sexual health.

Conclusions
These findings suggest that HRQOL measures from FKSI-19 must be refined among patients with mRCC. These findings will be validated in an upcoming study of patients with mRCC receiving systemic treatment in the metastatic and adjuvant settings.

Funding: Kidney Cancer Association’s 2021 Psychosocial Focus Award (PI: C D Bergerot)