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

Ravaud, A, Motzer, RJ, Pandha, Hardev S., 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, 375. pp. 2246-2254.

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Abstract

BACKGROUND

Sunitinib, a vascular endothelial growth factor pathway inhibitor, is an effective treatment for metastatic renal-cell carcinoma. We sought to determine the efficacy and safety of sunitinib in patients with locoregional renal-cell carcinoma at high risk for tumor recurrence after nephrectomy.

METHODS

In this randomized, double-blind, phase 3 trial, we assigned 615 patients with locoregional, high-risk clear-cell renal-cell carcinoma to receive either sunitinib (50 mg per day) or placebo on a 4-weeks-on, 2-weeks-off schedule for 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal. The primary end point was disease-free survival, according to blinded independent central review. Secondary end points included investigator-assessed disease-free survival, overall survival, and safety.

RESULTS

The median duration of disease-free survival was 6.8 years (95% confidence interval [CI], 5.8 to not reached) in the sunitinib group and 5.6 years (95% CI, 3.8 to 6.6) in the placebo group (hazard ratio, 0.76; 95% CI, 0.59 to 0.98; P=0.03). Overall survival data were not mature at the time of data cutoff. Dose reductions because of adverse events were more frequent in the sunitinib group than in the placebo group (34.3% vs. 2%), as were dose interruptions (46.4% vs. 13.2%) and discontinuations (28.1% vs. 5.6%). Grade 3 or 4 adverse events were more frequent in the sunitinib group (48.4% for grade 3 events and 12.1% for grade 4 events) than in the placebo group (15.8% and 3.6%, respectively). There was a similar incidence of serious adverse events in the two groups (21.9% for sunitinib vs. 17.1% for placebo); no deaths were attributed to toxic effects.

CONCLUSIONS

Among patients with locoregional clear-cell renal-cell carcinoma at high risk for tumor recurrence after nephrectomy, the median duration of disease-free survival was significantly longer in the sunitinib group than in the placebo group, at a cost of a higher rate of toxic events. (Funded by Pfizer; S-TRAC ClinicalTrials.gov number, 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, Hardev S.H.Pandha@surrey.ac.uk
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 : 8 December 2016
DOI : 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 : 31 Jul 2019 07:27
URI: http://epubs.surrey.ac.uk/id/eprint/812586

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