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Third-Line Sorafenib After Sequential Therapy With Sunitinib and mTOR Inhibitors in Metastatic Renal Cell Carcinoma.
MedLine Citation:
PMID:  20884115     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
BACKGROUND: Sunitinib and everolimus have been approved for first- and second-line treatment, respectively, in metastatic renal cell carcinoma (mRCC). The role of sorafenib, which is approved for second-line treatment after cytokines failure, is presently to be defined.
OBJECTIVE: To determine whether third-line sorafenib after sequential use of sunitinib and mammalian target of rapamycin inhibitors (everolimus or temsirolimus) is feasible and effective.
DESIGN, SETTING, AND PARTICIPANTS: One hundred fifty medical records of patients with mRCC treated with first-line sunitinib between January 2006 and January 2010 were reviewed at four participating centers. Data regarding patients treated with the sequence sunitinib-everolimus or temsirolimus-sorafenib were extracted. Central analysis of radiographic images was performed using RECIST criteria to determine progression-free survival (PFS) and overall response rate (oRR) to sorafenib treatment.
MEASUREMENTS: PFS and oRR to sorafenib were the primary end points. Secondary outcomes were safety and overall survival (OS).
RESULTS AND LIMITATIONS: Thirty-four patients were eligible for the study. A median PFS of 4 mo (range: 3-6 mo) and a median OS of 7 mo since sorafenib treatment (range: 6-10 mo) were reported. Of the patients, 23.5% showed response to sorafenib, with an overall disease control rate (complete responses plus partial responses plus stable disease) of 44%. Selection bias, data incompleteness, and absence of study design are inevitable limitations of the study, although central review can strengthen the quality of presented data.
CONCLUSIONS: Third-line sorafenib appears to be active and well tolerated in mRCC after first-line sunitinib and second-line everolimus or temsirolimus, with no patients interrupting sorafenib because of toxicity or lack of compliance. Prospective, placebo-controlled trials are completely lacking and are required in this setting.
Authors:
Giuseppe Di Lorenzo; Carlo Buonerba; Piera Federico; Pasquale Rescigno; Michele Milella; Cinzia Ortega; Michele Aieta; Carmine D'Aniello; Nicola Longo; Alessandra Felici; Enzo Maria Ruggeri; Giovannella Palmieri; Ciro Imbimbo; Massimo Aglietta; Sabino De Placido; Vincenzo Mirone
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Publication Detail:
Type:  Journal Article     Date:  2010-09-24
Journal Detail:
Title:  European urology     Volume:  58     ISSN:  1873-7560     ISO Abbreviation:  Eur. Urol.     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2011-03-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7512719     Medline TA:  Eur Urol     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  906-11     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Affiliation:
Dipartimento di Endocrinologia ed Oncologia Clinica e Molecolare, Università Federico II, Napoli, Italy.
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