(UroToday.com) The 2022 GU ASCO Annual meeting included a renal cell carcinoma (RCC) session highlighting work from Dr. David Cella and colleagues presenting five-year follow-up results of health-related quality of life in previously untreated patients with advanced RCC in CheckMate 214. Nivolumab + ipilimumab demonstrated durable, long-term survival in the phase 3 CheckMate 214 trial1-3 as first-line treatment for intermediate/poor-risk patients with advanced RCC. After a minimum follow-up of 5 years, nivolumab + ipilimumab maintained superior overall survival and response benefits versus sunitinib in both intermediate/poor-risk patients and across all randomized patients.4 In an initial analysis of health-related quality of life (minimum follow-up 17.5 months), nivolumab + ipilimumab was associated with sustained improvement in quality of life versus sunitinib in previously untreated intermediate/poor-risk patients with advanced RCC. At GU ASCO 2020, Dr. Cella reported the health-related quality of life results from the 5-year follow-up.
In CheckMate 214, patients were randomized 1:1 to receive nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks for 4 cycles followed by nivolumab 3 mg/kg every 2 weeks or sunitinib 50 mg/d orally for 4 weeks (6-week cycle). Health-related quality of life was assessed using the FKSI-19, FACT-G, and EQ-5D-3L instruments at baseline and on day 1 of weeks 1 and 4 of the first 2 cycles, on day 1 of weeks 1 and 5 of the next 2 cycles, and on day 1 of week 1 of subsequent cycles. The analyses included mixed-model repeated measures for change from baseline across 59 months (while on-treatment) and time to confirmed deterioration. Bother with treatment side effects (item GP5 in FKSI-19) was assessed using a generalized estimating equations model with response dichotomized as minimal bother (“not at all” or “a little bit”) vs notable bother (“somewhat”, “quite a bit”, and “very much”).
There were 1,096 patients randomized to nivolumab + ipilimumab (intermediate/poor-risk: 425; favorable-risk: 125) and sunitinib (intermediate/poor-risk: 422; favorable-risk: 124). In the overall and intermediate/poor-risk populations, nivolumab + ipilimumab patients reported improved mean FKSI-19 total scores over time compared with a decline observed with sunitinib. Overall changes from baseline through 59 months favored nivolumab + ipilimumab over sunitinib with significant differences between arms observed for all outcomes:
Median time to confirmed deterioration was significantly longer with nivolumab + ipilimumab vs sunitinib for all FKSI-19 scores, as well as FACT-G total and physical domains for both populations (p < 0.05):
Patients in the nivolumab + ipilimumab arm were 76% (OR 0.24, 95% CI 0.16–0.35) and 73% (OR 0.27, 95% CI 0.18–0.40) less likely to be notably bothered by side effects than patients in the sunitinib arm in the total and intermediate/poor-risk populations, respectively.
Dr. Cella concluded his presentation of five-year follow up results of health-related quality of life in previously untreated patients with advanced RCC in CheckMate 214 with the following concluding statements:
- Patients reported health-related quality of life benefits with nivolumab + ipilimumab compared with sunitinib
- Treatment with nivolumab + ipilimumab showed a decreased risk of being bothered by treatment side effects and of experiencing clinically meaningful deterioration in health-related quality of life in contrast with sunitinib
- These results suggest that the superior efficacy of nivolumab + ipilimumab over sunitinib comes with the additional benefit of improved long-term health-related quality of life
Presented by: David Cella, PhD, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL
Co-Authors: Toni Choueiri, Melissa Hamilton, Flavia Ejzykowicz, Steven I. Blum, Cristina Ivanescu, Robert J. Motzer
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19, 2022
- Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carinoma. N Engl J Med 2018;378(14):1277-1290.
- Motzer RJ, Rini BI, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: Extended follow-up of efficacy and safety results from a randomized, controlled, phase 3 trial. Lancet Oncol 2019 Oct;20(10):1370-1385.
- Escudier B, Motzer RJ, Tannir NM, et al. Efficacy of Nivolumab plus Ipilimumab According to Number of IMDC Risk Factors in CheckMate 214. Eur Urol 2020 Apr;77(4):449-453.
- Albiges L, Tannir NM, Burotto M, et al. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: Extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open 2020 Nov;5(6):e001079.