Clinical trials have demonstrated higher complete response (CR) rates in the immuno-oncology (IO)-based combination arms than in the tyrosine kinase inhibitor (TKI) arms in patients with metastatic renal cell carcinoma (mRCC). We aimed to characterize real-world patients who experienced CR to the contemporary first-line therapies.
Using the International mRCC Database Consortium (IMDC), response-evaluable patients who received frontline IO-based combination therapy or TKI monotherapy were analyzed. Baseline characteristics of patients and post-landmark overall survival (OS) were compared based on best overall response, as per RECIST 1.1.
A total of 52 (4.6%) of 1126 and 223 (3.0%) of 7557 patients experienced CR to IO-based and TKI therapies, respectively (P=.005). An adjusted odds ratio for CR achieved by IO-based combination therapy (versus TKI monotherapy) was 1.56 (95% CI 1.11-2.17; P=.009). Among patients who experienced CR, the IO-based cohort had a higher proportion of non-clear cell histology (15.9% and 4.7%; P=.016), sarcomatoid dedifferentiation (29.8% and 13.5%; P=.014), and multiple sites of metastases (80.4% and 50.0%; P<.001) than the TKI cohort. CR was independently associated with post-landmark OS benefit in both the IO-based and TKI cohorts, giving respective adjusted hazard ratios of 0.17 (95% CI 0.04-0.72; P=.016) and 0.28 (95% CI 0.21-0.38; P<.001).
The CR rate was not as high in the real-world population as in the clinical trial population. Among those who experienced CR, several adverse clinicopathological features were more frequently observed in the IO-based cohort than in the TKI cohort. CR was an indicator of favourable OS.
The Journal of urology. 2022 Dec 27 [Epub ahead of print]
Kosuke Takemura, Vishal Navani, Matthew S Ernst, J Connor Wells, Luis Meza, Sumanta K Pal, Jae-Lyun Lee, Haoran Li, Neeraj Agarwal, Ajjai S Alva, Aaron R Hansen, Naveen S Basappa, Bernadett Szabados, Thomas Powles, Ben Tran, Christopher M Hocking, Benoit Beuselinck, Takeshi Yuasa, Toni K Choueiri, Daniel Y C Heng
Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada., BC Cancer Agency, Vancouver, British Columbia, Canada., City of Hope Comprehensive Cancer Center, Duarte, California., Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea., Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah., University of Michigan Rogel Cancer Center, Ann Arbor, Michigan., Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada., Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada., Barts Cancer Institute, Queen Mary University of London, London, United Kingdom., Peter MacCallum Cancer Centre, Melbourne, Australia., Lyell McEwin Hospital, Adelaide, Australia., Leuven Cancer Institute, KU Leuven, Leuven, Belgium., Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan., Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.