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Updated: Jan 7, 2026

Ex Vivo Treatment Response of Primary Tumors and/or Associated Metastases for Preclinical and Clinical Development of Therapeutics
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First-Line Treatment with Tivozanib for Metastatic Renal Cell Carcinoma in Real-World Settings Across Germany:

Viktor Grünwald1, Karen Rußwurm2, Ralf Eckert3

  • 1Institute for Urologic Oncology, Essen University Hospital, 45147 Essen, Germany.

Cancers
|December 30, 2025
PubMed
Abstract

Insights

First-line tivozanib showed clinical activity and favorable tolerability in metastatic renal cell carcinoma (mRCC) patients in German real-world practice. Quality of life remained stable, even in elderly patients.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Tivozanib's efficacy and safety in first-line advanced/metastatic renal cell carcinoma (mRCC) established by Phase III TIVO-1 trial.
  • Real-world data needed to confirm outcomes in diverse clinical settings.

Purpose of the Study:

  • Evaluate safety, effectiveness, and quality of life (QoL) of first-line tivozanib in German mRCC patients.
  • Assess outcomes in a real-world clinical practice setting.

Main Methods:

  • Prospective T-Rex study in 32 mRCC patients in German clinical practice (May 2019-April 2021).
  • Assessed safety, effectiveness, and QoL during first-line tivozanib treatment.

Main Results:

  • 46.9% of patients achieved a clinical response (complete/partial).
  • 78.1% experienced treatment-related adverse events (e.g., diarrhea, nausea, blood pressure changes).
  • QoL remained stable; most toxicities resolved, except skin-related issues and hand-foot syndrome.

Conclusions:

  • First-line tivozanib demonstrated clinical activity and favorable tolerability in German real-world mRCC patients.
  • Stable QoL observed, including in elderly patients, supporting tivozanib use in routine practice.
Keywords:
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)advanced and metastatic renal cell carcinomapatient-reported outcomes (PRO)tivozanibtyrosine kinase inhibitor

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