Real-world experience of axitinib as second-line treatment in metastatic renal cell carcinoma: Analysis of the Swedish population.

Abstract

315 Background: Axitinib, a tyrosine kinase inhibitor of vascular endothelial growth factor receptors 1-3, was approved in 2012 for the treatment of metastatic renal cell carcinoma (mRCC) after failure of prior treatment with sunitinib or a cytokine. Outside of randomized clinical trials, it is important to describe the clinical outcomes of more heterogeneous populations. This analysis aimed to describe time-to-treatment discontinuation (TTD) and overall survival (OS) for second-line (2L) axitinib in a real-world setting for a nationwide Swedish mRCC cohort. Methods: This retrospective analysis utilized the Swedish Health Data Registers, covering the entire Swedish population. Patients (aged ≥ 18 years) with mRCC had ≥ 1 filled prescription of axitinib in the 2L setting, after an anti-angiogenic targeted therapy, from marketing approval until December 2019. This analysis relied on data relating to dispensed pack size, strength and according to dosing as recommended by the product label. A grace period of 90 days was allowed between filled prescriptions including medication accumulated from overlapping prescriptions. Kaplan-Meier methods were used to describe TTD and OS. Results: In total, 110 patients received 2L axitinib. Patients were predominantly male (n = 84, 76.4%) with a mean (SD) age of 60.9 (9.6) years at diagnosis and 65.5 (9.9) years at 2L treatment initiation. Median (95% confidence interval [CI]) time to TTD was 5.2 (3.7, 6.1) months, with 6 (5.5%) patients still receiving treatment at the time of analysis. Median OS (95% CI) was 12.2 (7.7, 14.2) months; 25.5% (n = 28) of patient data remained censored at the time of analysis. Conclusions: OS in this analysis of a real-world Swedish population was generally consistent with that of the pivotal 2L axitinib clinical trial in patients with mRCC who previously received sunitinib (median [95% CI] 15.2 [12.8, 18.3] months; Motzer et al. Lancet Oncol 2013; 14: 552–62). TTD was consistent with the reported progression-free survival (median 6.5 months [95% CI] 5.7–7.9]). These results provide reassurance for the effectiveness of 2L axitinib in an unselected patient population in a real-world setting.