(UroToday.com) The 2024 GU ASCO annual meeting featured a renal cell carcinoma session and a presentation by Dr. Cristiane Bergerot discussing development of a patient-centered health-related quality of life measure for metastatic renal cell carcinoma. Patients with metastatic RCC require a tailored health-related quality of life assessment.
Previous research explored FKSI-19, EORTC QLQ-C30, and EQ-5D item relevance.1-2 The pivotal first-line kidney cancer trials have assessed health related quality of life using multiple tools and different analyses, however, this has generated a plethora of exploratory results that can be challenging to interpret:
Furthermore, some of the tools we are using go back 30 years when our current treatments did not exist:
As such, Dr. Bergerot and colleagues aimed to develop a tailored health-related quality of life measure for patients with metastatic RCC through a three-phase approach involving patient engagement, expert input, and advocacy.
In Phase 1, 117 patients with metastatic RCC (83:34 male: female, median age 64 years) from the US, Europe, and Brazil participated in a survey study to assess the relevance of items from established measures (FKSI-19, EORTC QLQ-C30, EQ-5D). In this cohort, 88% of patients had clear cell histology, and 35%, 30%, and 19% received immunotherapy alone, targeted therapy alone, or combination therapy, respectively:
Questions identified as relevant (based on ≥66% consensus) were selected for inclusion in a preliminary survey. Phase 2 involved assembling a panel of 11 experts who rigorously reviewed and refined survey questions. In Phase 3, the preliminary version were presented to 8 patient advocates (5:3 female: male; 6:2 patients: caregivers) to ensure alignment with patients' needs and experiences.
In Phase 1, among 54 questions, 15/54 (27%) were deemed relevant:
Patients requested the inclusion of a question about social/family issues and better coverage of emotional symptoms. A 12-item questionnaire was created, and the expert committee (phase 2) refined three items to incorporate patient suggestions and added one item related to functional status:
This questionnaire included one cancer-specific item, three cancer or treatment-specific items, three non-specific emotional items, and four non-specific physical items:
Patient advocates (phase 3) provided feedback, agreeing with the items excluded from previous questionnaires and those included. They suggested minor edits to item wording:
Dr. Bergerot concluded her presentation discussing development of a patient-centered health-related quality of life measure for metastatic renal cell carcinoma with the following take-home points:
- Quality of life areas of priority were identified for patients with kidney cancer receiving treatment
- Some questions appear less relevant, which push comparative analysis toward the null hypothesis
- This study created a new model using a multidisciplinary team, which may be more relevant
- Validation of this new model is now required
- The final model in advanced disease will be validated in upcoming trials:
- Retrospective analysis: PRISM study
- Primary assessment of health related quality of life: CARE-1 study
- Dr. Bergerot notes that her group is inviting groups with available quality of life data to collaborate in order to test and validate the model
Presented by: Cristiane Decat Bergerot, PhD, Oncoclinicas, Brasilia, Brazil
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Jan 25 – Sat, Jan 27, 2024.
References:
- Bergerot CD, Malhotra J, Bergerot P, et al. Patients’ Perceptions Regarding the Relevance of Items Contained in the Functional Assessment of Cancer Therapy Kidney Symptom Index-19. Oncologist. 2023 Jun 2;28(6):494-500.
- Bergerot CD, Liu, Pal SK. End-of-life care among patients with metastatic renal cell carcinoma: Importance of a patient-centric focus in clinical decision making. JCO Oncol Pract. 2023 Feb;19(2):70-71.