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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.
- Source :
-
Tumori [Tumori] 2015 Nov-Dec; Vol. 101 (6), pp. 701-3. Date of Electronic Publication: 2015 Jun 20. - Publication Year :
- 2015
-
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.<br />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.
- Subjects :
- Adult
Aged
Antineoplastic Agents adverse effects
Axitinib
Carcinoma, Renal Cell mortality
Carcinoma, Renal Cell 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 mortality
Kidney Neoplasms pathology
Male
Middle Aged
Niacinamide administration & dosage
Niacinamide analogs & derivatives
Phenylurea Compounds administration & dosage
Prospective Studies
Protein Kinase Inhibitors adverse effects
Pyrimidines administration & dosage
Pyrroles administration & dosage
Quality of Life
Sorafenib
Sulfonamides administration & dosage
Sunitinib
Treatment Outcome
Antineoplastic Agents therapeutic use
Carcinoma, Renal Cell drug therapy
Kidney Neoplasms drug therapy
Protein Kinase Inhibitors therapeutic use
TYK2 Kinase antagonists & inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 2038-2529
- Volume :
- 101
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Tumori
- Publication Type :
- Academic Journal
- Accession number :
- 26108242
- Full Text :
- https://doi.org/10.5301/tj.5000335