368 476
Platinum Priority – Kidney Cancer
Editorial by Michael S. Humeniuk and Andrew J. Armstrong on pp. 377–378 of this issue
Treatment Beyond Progression in Patients with Advanced Renal
Cell Carcinoma Treated with Nivolumab in CheckMate 025
Bernard Escudier
a , * ,Robert J. Motzer
b ,Padmanee Sharma
c ,John Wagstaff
d ,Elizabeth R. Plimack
e ,Hans J. Hammers
f , 1[5_TD$DIFF]
,Frede Donskov
g ,Howard Gurney
h ,Jeffrey A. Sosman
i , 2[6_TD$DIFF]
,Pawel G. Zalewski
j ,Ulrika Harmenberg
k ,David F. McDermott
l ,Toni K. Choueiri
m, Martin Richardet
n ,Yoshihiko Tomita
o ,Alain Ravaud
p ,Justin Doan
q ,Huanyu Zhao
q ,Helene Hardy
q ,Saby George
ra
Department of Medical Oncology, Gustave Roussy, Villejuif, France;
b
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA;
c
Department of Genitourinary Medical Oncology, Department of Immunology, MD Anderson Cancer Center, University of Texas, Houston, TX, USA;
d
Department of Medical Oncology, South West Wales Cancer Institute and Swansea University College of Medicine, Swansea, UK;
e
Department of
Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA;
f
Department of Medical Oncology, Johns Hopkins Sidney Kimmel Comprehensive
Cancer Center, Baltimore, MD, USA;
g
Department of Oncology, Aarhus University Hospital, Aarhus, Denmark;
h
Department of Medical Oncology, Westmead
Hospital and Macquarie University, Sydney, Australia;
i
Department of Hematology, Vanderbilt University Medical Center, Nashville, TN, USA;
j
Department of
Oncology, Lakeridge Health RS McLaughlin Durham Regional Cancer Centre, Oshawa, ON, Canada;
k
Department of Oncology, Radiumhemmet, Karolinska
University Hospital, Stockholm, Sweden;
l
Biologic Therapy and Cutaneous Oncology Programs, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard
Cancer Center, Boston, MA, USA;
m
Kidney Cancer Center, Department of Medical Oncology, Dana-Farber Cancer Institute/Brigham and Women’s Hospital,
Boston, MA, USA;
n
Department of Medical Oncology, Instituto Oncologico de Cordoba, Cordoba, Argentina;
o
Department of Urology, Department of
Molecular Oncology, Niigata University, Niigata, Japan;
p
Department of Medical Oncology and Radiotherapy, Bordeaux University Hospital, Hoˆpital Saint
Andre´, Bordeaux, France;
q
Bristol-Myers Squibb, Princeton, NJ, USA;
r
Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 3 6 8 – 3 7 6available at
www.scienced irect.comjournal homepage:
www.europeanurology.comArticle info
Article history:
Accepted March 24, 2017
Associate Editor:
Stephen Boorjian
Keywords:
Advanced renal cell carcinoma
Everolimus
Nivolumab
Phase 3
Treatment beyond progression
Abstract
Background:
Response patterns to nivolumab differ from those seen with other ap-
proved targeted therapies.
Objective:
To investigate the efficacy of nivolumab in previously treated patients with
advanced renal cell carcinoma who were treated beyond (Response Evaluation Criteria
In Solid Tumors) RECIST progression.
Design, setting, and participants:
This was a subgroup analysis of patients treated with
nivolumab in the phase 3 CheckMate 025 study. Patients continuing to tolerate therapy
and exhibiting investigator-assessed clinical benefit were eligible to be treated beyond
RECIST progression (TBP) and received therapy for 4 wk after first progression; patients
not treated beyond RECIST progression (NTBP) received 0 wk to
<
4 wk of therapy after
progression.
Interventions:
Nivolumab 3 mg/kg intravenously every 2 wk.
Results and limitations:
Of 406 nivolumab-treated patients, 316 (78%) progressed by
RECIST criteria. Of those who progressed, 48% were TBP, 52% were NTBP. Before being
TBP, objective response rate (95% confidence interval) was 20% (14–28) and 14% (9–21)
[5_TD$DIFF]
1
Current affiliation: Division of Hematology and Oncology, UT Southwestern – Kidney Cancer
Program, Dallas, TX, USA.
[6_TD$DIFF]
2
Current affiliation: Department of Hematology/Medical Oncology, Robert Lurie Comprehensive
Cancer Center of Northwestern University, Chicago, IL, USA.
* Corresponding author. Department of Medical Oncology, Gustave Roussy, 114 Rue Edouard
Vaillant, 94800 Villejuif, France. Tel. +33 0 1 42 11 54 10.
E-mail address:
escudier@gustaveroussy.fr(B. Escudier).
http://dx.doi.org/10.1016/j.eururo.2017.03.0370302-2838/
#
2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.