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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 :
AuthorsEmailORCID
Ravaud, AUNSPECIFIEDUNSPECIFIED
Motzer, RJUNSPECIFIEDUNSPECIFIED
Pandha, HSUNSPECIFIEDUNSPECIFIED
George, DJUNSPECIFIEDUNSPECIFIED
Pantuck, AJUNSPECIFIEDUNSPECIFIED
Patel, AUNSPECIFIEDUNSPECIFIED
Chang, YHUNSPECIFIEDUNSPECIFIED
Escudier, BUNSPECIFIEDUNSPECIFIED
Donskov, FUNSPECIFIEDUNSPECIFIED
Magheli, AUNSPECIFIEDUNSPECIFIED
Carteni, GUNSPECIFIEDUNSPECIFIED
Laguerre, BUNSPECIFIEDUNSPECIFIED
Tomczak, PUNSPECIFIEDUNSPECIFIED
Breza, JUNSPECIFIEDUNSPECIFIED
Gerletti, PUNSPECIFIEDUNSPECIFIED
Lechuga, MUNSPECIFIEDUNSPECIFIED
Lin, XUNSPECIFIEDUNSPECIFIED
Martini, JFUNSPECIFIEDUNSPECIFIED
Ramaswamy, KUNSPECIFIEDUNSPECIFIED
Casey, MUNSPECIFIEDUNSPECIFIED
Staehler, MUNSPECIFIEDUNSPECIFIED
Patard, JJUNSPECIFIEDUNSPECIFIED
Date : 10 October 2016
Identification Number : https://doi.org/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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