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.

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.