Real-World Results from One Year of Therapy with Tivozanib

Abstract

Introduction: Tivozanib was approved in Europe in November 2017. We report on our initial experience of the use of Tivozanib in metastatic Renal Cell Carcinoma (RCC). Material and Methods: N = 23 patients undergoing Tivozanib therapy were included in this retrospective analysis from a prospective database at the Multidisciplinary Center on Renal Tumors, Department of Urology, University of Munich between Nov. 2017 and Oct. 2018. Results: Median age was 69.1 years (range 42.7-83.8) n = 8 patients were started on tivozanib in first line (34.8%) and n = 15 (75.2% in later line therapy (2nd-6th line). Tumor response according to RECIST criteria was PR in 39.1%, SD in 52.2% and PD in 8.7% of the patients. Median progression free survival (PFS) was 14.9 months (95% CI 5.1-24.8). Median overall survival (OS) has not been reached. Although not statistically significant the difference in median PFS for first line patients was 30.3 months versus later line patients of 8.6 months (CI 5.1-12.2) (p = 0.291). The most commonly reported side-effects were diarrhea, hypertension, fatigue and hoarseness. 34.8% of the patients had grade 2 side effects and 21.7% had grade 3 adverse events, leading to treatment discontinuation in 3 patients (13%). Conclusion: Tivozanib is a highly active tyrosine kinase inhibitor even in later lines of therapy. The side effects are well tolerated, and no new safety signals were detected.