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Real-World Efficacy and Toxicity of Ipilimumab and Nivolumab as First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC) in a Subpopulation of Elderly and Poor Performance Status Patients
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DOI：10.3390/cancers17030522.png)
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Abstract
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Background: Ipilimumab and nivolumab (ipi/nivo) improved overall survival (OS) compared to sunitinib in the pivotal Checkmate 214 trial of metastatic renal cell carcinoma (mRCC) with International Metastatic RCC Database Consortium (IMDC) intermediate/poor risk disease. We evaluated the efficacy and toxicity of ipi/nivo in older and frailer populations in a real-world mRCC cohort. Methods: Analysis was conducted on a real-world cohort with mRCC (N = 551) treated with first-line ipi/nivo from the Canadian Kidney Cancer information system (CKCis) database from January 2014 to December 2021. A comparison was made between outcomes and toxicity in patients 1. <70 versus (vs.) >= 70 yo, 2. <75 vs. >= 75 yo, and 3. KPS >= 70 vs. <70 yo. OS, progression-free survival (PFS), and time to treatment failure (TTF) were calculated by Kaplan-Meier analysis. Log-rank tests were used for comparison between groups. Results: Ipi/nivo treatment had no impact on survival outcomes or toxicity for patients >70 yo and >75 yo when controlled for IMDC. However, when comparing patients with KPS > 70 vs. KPS < 70, patients with a poor performance status had decreased median OS at 54.5 m vs. 10.8 m (p-value < 0.0001) and PFS at 11.6 vs. 3.1 m (p-value < 0.0001). Conclusions: The use of ipi/nivo in mRCC demonstrated similar survival outcomes and toxicity in an older patient population. In patients with a poor performance status, it was associated with inferior OS and PFS. We believe that ipi/nivo is a reasonable treatment option for these patient populations, particularly in older patients.
Keywords:
metastatic renal cell carcinoma
ipilimumab and nivolumab
elderly
poor performance status
low KPS
efficacy
toxicity
real-world evidence
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