TOKIO rationale and protocol: A phase II study to evaluate the activity and safety of third-line tyrosine kinase inhibitor after 2 tyrosine kinase inhibitors in patients with metastatic renal cell carcinoma

Elena Verzoni, Paolo Grassi, Rosanna Montone, Giulia Galli, Andrea Necchi, Giuseppe Procopio

Research output: Contribution to journalArticlepeer-review

Abstract

Aims and background: The introduction of agents targeting vascular endothelial growth factor has radically changed the approach to metastatic renal cell carcinoma (mRCC): sunitinib and pazopanib are now the standard first-line therapy in mRCC. At sunitinib failure, second-line axitinib or everolimus or sorafenib should be considered to improve the clinical outcome. No data are available for a third-line tyrosine kinase inhibitor (TKI) after 2 previous lines of therapy with TKIs. At pazopanib failure, no prospective data are available. Study design: The TOKIO study was designed to evaluate progression-free survival, safety, and efficacy of third-line therapy with TKI in 44 patients already treated with 2 previous lines of TKIs in 10 Italian centers, and relapsed from sunitinib-axitinib (group A) or pazopanib-sorafenib (group B). Standard treatment is sorafenib in group A and sunitinib in group B, administered until disease progression or unacceptable toxicity. Secondary endpoints include the evaluation of overall survival, safety, and quality of life.

Original languageEnglish
Pages (from-to)701-703
Number of pages3
JournalTumori
Volume101
Issue number6
DOIs
Publication statusPublished - Nov 1 2015

Keywords

  • Renal cell carcinoma
  • Sequence therapy
  • Sorafenib
  • Sunitinib

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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