First-line treatment with tivozanib for metastatic renal cell carcinoma in real-world settings across Germany : results of the prospective, non-interventional, post-approval study T-Rex

Abstract

Background: The efficacy and safety of tivozanib for the treatment of advanced or metastatic renal cell carcinoma (mRCC) have been established in the first-line setting in the Phase III trial TIVO-1. Methods: The prospective T-Rex study conducted in German clinical practice evaluated the safety, effectiveness and impact on quality of life (QoL) of first-line treatment with tivozanib in 32 patients with mRCC recruited between May 2019 and April 2021. Results: Recruited patients were predominantly elderly, with 53.1% aged over 75 years. Patients received a median of 6.5 tivozanib treatment cycles and the median time on treatment was 5.7 months. Overall, 78.1% of patients experienced treatment-related adverse events, including diarrhea, nausea and hypotension/hypertension. A clinical (i.e., complete or partial) response was observed in 46.9% of patients. Patients’ QoL remained stable from baseline to the end of treatment and most symptomatic toxicities resolved by the final treatment cycle, with the exclusion of dry skin, itching, and hand–foot syndrome. Conclusions: These data demonstrate that first-line treatment with tivozanib was associated with clinical activity, favorable tolerability, and stable QoL in patients with mRCC treated in everyday clinical practice across Germany, including those with advanced age.