62 148
Platinum Priority
–
Kidney Cancer
Editorial by Jozefina Casuscelli and James J. Hsieh on pp. 69
–
70 of this issue
Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After
Nephrectomy: Subgroup Analyses and Updated Overall Survival
Results
Robert J. Motzer
a , * , Alain Ravaud b , Jean-Jacques Patard c , Hardev S. Pandha d , Daniel J. George e ,Anup Patel
f , Yen-Hwa Chang g , Bernard Escudier h , Frede Donskov i , Ahmed Magheli j ,Giacomo Carteni
k , Brigitte Laguerre l , Piotr Tomczak m , Jan Breza n , Paola Gerletti o ,Mariajose Lechuga
o , Xun Lin p , Michelle Casey q , Lucile Serfass r , Allan J. Pantuck s , y ,Michael Staehler
t , ya
Department of Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA;
b
Department of Medical Oncology, Bordeaux University Hospital,
Bordeaux, France;
c
Centre Hospitalier De Mont De Marsan, Mont-de-Marsan, France;
d
Department of Clinical and Experimental Medicine and Department
of Microbial Sciences, University of Surrey, Guildford, UK;
e
Division of Oncology, Duke Cancer Center, Durham, NC, USA;
f
Spire Roding Hospital, London, UK;
g
Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan;
h
Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France;
i
Department of Oncology, Aarhus University Hospital, Aarhus, Denmark;
j
Department of Urology, Charité Universitaetsmedizin Berlin, Berlin, Germany;
k
Division of Oncology and Division of Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy;
l
Medical Oncology, Centre Eugene
Marquis, Rennes, France;
m
Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland;
n
Department of Urology, Slovak Medical University in Bratislava,
Bratislava, Slovakia;
o
Pfizer S.r.L, Milan, Italy;
p
Pfizer Inc., La Jolla, CA, USA;
q
Pfizer Inc., Collegeville, PA, USA;
r
Pfizer Oncology, Paris, France;
s
Department of
Urology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA;
t
Department of Urology, University Hospital of Munich, Munich, Germany
E U R O P E A N U R O L O GY 7 3 ( 2 0 18 ) 6 2 – 6 8available at
www.scienced irect.comjournal homepage:
www.europeanurology.comArticle info
Article history:
Accepted September 7, 2017
Associate Editor:
Giacomo Novara
Statistical Editor:
Andrew Vickers
Keywords:
Adjuvant
Disease-free survival
Renal cell carcinoma
Sunitinib
Abstract
Background:
Adjuvant sunitinib significantly improved disease-free survival (DFS)
versus placebo in patients with locoregional renal cell carcinoma (RCC) at high risk
of recurrence after nephrectomy (hazard ratio [HR] 0.76, 95% confidence interval [CI]
0.59
–
0.98;
p
= 0.03).
Objective:
To report the relationship between baseline factors and DFS, pattern of
recurrence, and updated overall survival (OS).
Design, setting, and participants:
Data for 615 patients randomized to sunitinib
(
n
= 309) or placebo (
n
= 306) in the S-TRAC trial.
Outcome measurements and statistical analysis:
Subgroup DFS analyses by baseline risk
factors were conducted using a Cox proportional hazards model. Baseline risk factors
included: modi
fi
ed University of California Los Angeles integrated staging system
criteria, age, gender, Eastern Cooperative Oncology Group performance status (ECOG
PS), weight, neutrophil-to-lymphocyte ratio (NLR), and Fuhrman grade.
Results and limitations:
Of 615 patients, 97 and 122 in the sunitinib and placebo arms
developed metastatic disease, with the most common sites of distant recurrence being
lung (40 and 49), lymph node (21 and 26), and liver (11 and 14), respectively. A bene
fi
t of
adjuvant sunitinib over placebo was observed across subgroups, including: higher risk
(T3, no or undetermined nodal involvement, Fuhrman grade 2, ECOG PS 1, T4 and/or
y
These authors contributed equally.
* Corresponding author. Department of Oncology, Memorial Sloan Kettering Cancer Center,
1275 York Ave, New York, NY 10065, USA. Tel. +1 212 6392000; Fax: +1 212 9880719.
E-mail address:
motzerr@mskcc.org(R.J. Motzer).
http://dx.doi.org/10.1016/j.eururo.2017.09.0080302-2838/© 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.