Skip to main content

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

Publication ,  Journal Article
Ravaud, A; Motzer, RJ; Pandha, HS; George, DJ; Pantuck, AJ; Patel, A; Chang, Y-H; Escudier, B; Donskov, F; Magheli, A; Carteni, G; Laguerre, B ...
Published in: N Engl J Med
December 8, 2016

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 .).

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

December 8, 2016

Volume

375

Issue

23

Start / End Page

2246 / 2254

Location

United States

Related Subject Headings

  • Young Adult
  • Survival Analysis
  • Sunitinib
  • Pyrroles
  • Nephrectomy
  • Middle Aged
  • Male
  • Kidney Neoplasms
  • Indoles
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ravaud, A., Motzer, R. J., Pandha, H. S., George, D. J., Pantuck, A. J., Patel, A., … S-TRAC Investigators, . (2016). Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med, 375(23), 2246–2254. https://doi.org/10.1056/NEJMoa1611406
Ravaud, Alain, Robert J. Motzer, Hardev S. Pandha, Daniel J. George, Allan J. Pantuck, Anup Patel, Yen-Hwa Chang, et al. “Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy.N Engl J Med 375, no. 23 (December 8, 2016): 2246–54. https://doi.org/10.1056/NEJMoa1611406.
Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, et al. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246–54.
Ravaud, Alain, et al. “Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy.N Engl J Med, vol. 375, no. 23, Dec. 2016, pp. 2246–54. Pubmed, doi:10.1056/NEJMoa1611406.
Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang Y-H, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini J-F, Ramaswamy K, Casey M, Staehler M, Patard J-J, S-TRAC Investigators. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246–2254.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

December 8, 2016

Volume

375

Issue

23

Start / End Page

2246 / 2254

Location

United States

Related Subject Headings

  • Young Adult
  • Survival Analysis
  • Sunitinib
  • Pyrroles
  • Nephrectomy
  • Middle Aged
  • Male
  • Kidney Neoplasms
  • Indoles
  • Humans