Forskning

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

Publikation: Forskning - peer reviewTidsskriftartikel

DOI

  • Alain Ravaud
    Alain Ravaud
  • Robert J Motzer
    Robert J Motzer
  • Hardev S Pandha
    Hardev S Pandha
  • Daniel J George
    Daniel J George
  • Allan J Pantuck
    Allan J Pantuck
  • Anup Patel
    Anup Patel
  • Yen-Hwa Chang
    Yen-Hwa Chang
  • Bernard Escudier
    Bernard Escudier
  • Frede Donskov
  • Ahmed Magheli
    Ahmed Magheli
  • Giacomo Carteni
    Giacomo Carteni
  • Brigitte Laguerre
    Brigitte Laguerre
  • Piotr Tomczak
    Piotr Tomczak
  • Paola Gerletti
    Paola Gerletti
  • Mariajose Lechuga
    Mariajose Lechuga
  • Xun Lin
    Xun Lin
  • Jean-Francois Martini
    Jean-Francois Martini
  • Krishnan Ramaswamy
    Krishnan Ramaswamy
  • Michelle Casey
    Michelle Casey
  • Michael Staehler
    Michael Staehler
  • Jean-Jacques Patard
    Jean-Jacques Patard
  • S-TRAC Investigators
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.)
OriginalsprogEngelsk
TidsskriftThe New England Journal of Medicine
Vol/bind375
Tidsskriftsnummer23
Sider (fra-til)2246-2254
Antal sider9
ISSN0028-4793
DOI
StatusUdgivet - 8 dec. 2016

Se relationer på Aarhus Universitet Citationsformater

ID: 107839808