Abstract
Combination therapy with immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor tyrosine kinase inhibitors (VEGF TKIs) is standard of care for metastatic renal cell carcinoma (mRCC); however, no head-to-head trials have compared FDA-approved regimens. This project aims to provide real-world data on the safety and efficacy of axitinib + pembrolizumab in the treatment of mRCC and describe management of common treatment-related adverse events. This is a retrospective, observational, quality improvement project conducted at the Robert H Lurie Comprehensive Cancer Center of Northwestern University in Chicago, Illinois. Patients 18 years of age or older with stage IV RCC who received axitinib + pembrolizumab between April 2019 and February 2024 were included. Endpoints included progression-free survival (PFS), overall survival (OS), duration of treatment, subsequent therapies, and safety outcomes. Thirty-one patients received axitinib + pembrolizumab for mRCC. With a median follow-up time of 22.6 months, PFS was 37.4 months and OS was not reached. Ninety-four percent of patients experienced a treatment-related adverse event with 32.3% classified as grade 3 or higher. Fifty two percent of patients required axitinib dose reductions, 70.9% had at least one axitinib dose held, and 70.9% had at least one pembrolizumab dose held. Patients with axitinib dose reductions demonstrated improved OS at one year (92.9% vs. 80%). This retrospective study corroborates the findings of the KEYNOTE-426 trial and further demonstrates the effectiveness of axitinib + pembrolizumab combination therapy in the treatment of mRCC. Dose reductions and holds do not appear to impact treatment efficacy.
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