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.

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.

• Authors: Elena Verzoni, Paolo Grassi, Rosanna Montone, Giulia Galli, Andrea Necchi, Giuseppe Procopio
• Journal: Tumori (Tumori) 2015 Nov-Dec Vol. 101 Issue 6 Pg. 701-3 ISSN: 2038-2529 [Electronic] United States
• PMID: 26108242 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents
• Imidazoles
• Indazoles
• Indoles
• Phenylurea Compounds
• Protein Kinase Inhibitors
• Pyrimidines
• Pyrroles
• Sulfonamides
• Niacinamide
• pazopanib
• Everolimus
• Sorafenib
• Axitinib
• TYK2 Kinase
• Sunitinib

Topics

• Adult
• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Axitinib
• Carcinoma, Renal Cell (drug therapy, mortality, secondary)
• Clinical Protocols
• Disease-Free Survival
• Everolimus (administration & dosage)
• Female
• Humans
• Imidazoles (administration & dosage)
• Indazoles (administration & dosage)
• Indoles (administration & dosage)
• Kaplan-Meier Estimate
• Kidney Neoplasms (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Niacinamide (administration & dosage, analogs & derivatives)
• Phenylurea Compounds (administration & dosage)
• Prospective Studies
• Protein Kinase Inhibitors (adverse effects, therapeutic use)
• Pyrimidines (administration & dosage)
• Pyrroles (administration & dosage)
• Quality of Life
• Sorafenib
• Sulfonamides (administration & dosage)
• Sunitinib
• TYK2 Kinase (antagonists & inhibitors)
• Treatment Outcome