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Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy

Ravaud, A, Motzer, RJ, Pandha, HS, George, DJ, Pantuck, AJ, Patel, A, Chang, YH, Escudier, B, Donskov, F, Magheli, A , Carteni, G, Laguerre, B, Tomczak, P, Breza, J, Gerletti, P, Lechuga, M, Lin, X, Martini, JF, Ramaswamy, K, Casey, M, Staehler, M and Patard, JJ (2016) Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy New England Journal of Medicine.

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Abstract

Background: Sunitinib is an effective treatment for metastatic renal cell carcinoma (RCC). This randomized, double-blind phase 3 trial examined the efficacy and safety of sunitinib versus placebo in patients with loco-regional RCC at high risk of tumor recurrence post-nephrectomy. Methods: Treatment-naïve patients (n=615) with loco-regional high-risk (≥T3 and/or N1–2) clear-cell RCC were randomized 1:1 to receive sunitinib or placebo (50 mg/d) on a 4-weeks-on/2-weeks-off schedule for 1 year until disease recurrence, significant toxicity, or consent withdrawal. The primary endpoint was disease-free survival by blinded independent central review. Secondary analyses and endpoints included investigator-assessed disease-free survival, overall survival, and safety. Results: Sunitinib improved disease-free survival compared with placebo based on blinded independent central review (hazard ratio, 0.761; 95% confidence interval, 0.594–0.975; P=0.030, median: 6.8 vs. 5.6 years). Investigator-assessed disease-free survival also favored sunitinib (hazard ratio: 0.811, 95% confidence interval, 0.643–1.023; P=0.077; median: 6.5 vs. 4.5 years). Grade ≥3 adverse events were more frequent with sunitinib (63.7%) versus placebo (22.0%), whereas the incidence of serious adverse events was similar (22.2% vs. 17.4%, respectively); no deaths occurred due to treatment toxicity. Conclusions: Sunitinib treatment in the adjuvant setting prolonged disease-free survival in patients with loco-regional RCC at high risk for tumor recurrence post-nephrectomy. Trial Registration number: ClinicalTrials.gov, NCT00375674

Item Type: Article
Subjects : Medical Science
Divisions : Faculty of Health and Medical Sciences > School of Biosciences and Medicine
Authors :
NameEmailORCID
Ravaud, A
Motzer, RJ
Pandha, HS
George, DJ
Pantuck, AJ
Patel, A
Chang, YH
Escudier, B
Donskov, F
Magheli, A
Carteni, G
Laguerre, B
Tomczak, P
Breza, J
Gerletti, P
Lechuga, M
Lin, X
Martini, JF
Ramaswamy, K
Casey, M
Staehler, M
Patard, JJ
Date : 10 October 2016
Identification Number : 10.1056/NEJMoa1611406
Copyright Disclaimer : From The New England Journal of Medicine, A. Ravaud et al, Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy Copyright © 2016 Massachusetts Medical Society. Reprinted with permission.
Depositing User : Symplectic Elements
Date Deposited : 25 Oct 2016 11:02
Last Modified : 10 Apr 2017 02:08
URI: http://epubs.surrey.ac.uk/id/eprint/812586

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