PMID- 28419248
OWN - NLM
STAT- MEDLINE
DCOM- 20171205
LR  - 20220316
IS  - 1465-3621 (Electronic)
IS  - 0368-2811 (Print)
IS  - 0368-2811 (Linking)
VI  - 47
IP  - 7
DP  - 2017 Jul 1
TI  - Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup 
      analysis from the CheckMate 025 study.
PG  - 639-646
LID - 10.1093/jjco/hyx049 [doi]
AB  - BACKGROUND: Nivolumab improved overall survival (OS) and objective response rate 
      (ORR) versus everolimus in previously treated patients with advanced renal cell 
      carcinoma in the phase III CheckMate 025 study (minimum follow-up: 14 months). We 
      report efficacy and safety in the global and Japanese populations (minimum 
      follow-up: 26 months). METHODS: Patients were randomized 1:1 to receive nivolumab 
      3 mg/kg intravenously every 2 weeks or everolimus 10-mg tablet orally once daily. 
      Primary endpoint: OS, key secondary endpoints: ORR, progression-free survival and 
      safety. RESULTS: Of 410 (nivolumab) and 411 (everolimus) patients, 37 (9%) and 26 
      (6%), respectively, were Japanese. Median OS for the global population was 26.0 
      months (nivolumab) and 19.7 months (everolimus; hazard ratio 0.73 [95% confidence 
      interval [CI]: 0.61-0.88]; P = 0.0006), with medians not reached for Japanese 
      patients. ORR for the global population was 26% (nivolumab) versus 5% 
      (everolimus; odds ratio 6.13; 95% CI: 3.77-9.95); ORR for Japanese patients: 43% 
      versus 8% (odds ratio 9.14; 95% CI: 1.76-88.33). In Japanese patients, any-grade 
      treatment-related adverse events (AEs) occurred in 78% (Grade 3-4, 19%; most 
      common, anemia [5%]) treated with nivolumab and 100% (Grade 3-4, 58%; most 
      common, hypertriglyceridemia [12%]) treated with everolimus; the most common with 
      nivolumab was diarrhea (19%) and with everolimus was stomatitis (77%). Quality of 
      life was stable in the nivolumab arm. CONCLUSIONS: With >2 years of follow-up, 
      Japanese patients had a higher response rate with nivolumab versus everolimus 
      that was more pronounced yet consistent with the global population, with median 
      OS not reached, and a favorable safety profile.
CI  - (c) The Author 2017. Published by Oxford University Press.
FAU - Tomita, Yoshihiko
AU  - Tomita Y
AD  - Department of Urology, Yamagata University Hospital, Yamagata.
AD  - Department of Urology, Molecular Oncology, Graduate School of Medical and Dental 
      Sciences, Niigata University, Niigata, Japan.
FAU - Fukasawa, Satoshi
AU  - Fukasawa S
AD  - Prostate Center and Division of Urology, Chiba Cancer Center, Chiba.
FAU - Shinohara, Nobuo
AU  - Shinohara N
AD  - Department of Urology, Hokkaido University, Sapporo.
FAU - Kitamura, Hiroshi
AU  - Kitamura H
AD  - Department of Urology, Sapporo Medical University Hospital, Sapporo.
AD  - Department of Urology, University of Toyama, Toyama, Japan.
FAU - Oya, Mototsugu
AU  - Oya M
AD  - Department of Urology, Keio University Hospital, Tokyo.
FAU - Eto, Masatoshi
AU  - Eto M
AD  - Department of Urology, Kumamoto University, Kumamoto.
AD  - Department of Urology, Graduate School of Medical Sciences, Kyushu University, 
      Fukuoka, Japan.
FAU - Tanabe, Kazunari
AU  - Tanabe K
AD  - Department of Urology, Tokyo Women's Medical University Hospital, Tokyo.
FAU - Kimura, Go
AU  - Kimura G
AD  - Department of Urology, Nippon Medical School Hospital, Tokyo.
FAU - Yonese, Junji
AU  - Yonese J
AD  - Department of Urology, Cancer Institute Hospital, Tokyo.
FAU - Yao, Masahiro
AU  - Yao M
AD  - Department of Urology, Yokohama City University Hospital, Yokohama, Japan.
FAU - Motzer, Robert J
AU  - Motzer RJ
AD  - Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, 
      USA.
FAU - Uemura, Hirotsugu
AU  - Uemura H
AD  - Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan.
FAU - McHenry, M Brent
AU  - McHenry MB
AD  - Global Biometric Sciences, Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Berghorn, Elmer
AU  - Berghorn E
AD  - Global Clinical Research, Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Ozono, Seiichiro
AU  - Ozono S
AD  - Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Jpn J Clin Oncol
JT  - Japanese journal of clinical oncology
JID - 0313225
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Immunosuppressive Agents)
RN  - 31YO63LBSN (Nivolumab)
RN  - 9HW64Q8G6G (Everolimus)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/*administration & dosage
MH  - Carcinoma, Renal Cell/*drug therapy/mortality/pathology
MH  - Disease-Free Survival
MH  - Everolimus/*administration & dosage
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage
MH  - Kidney Neoplasms/*drug therapy/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Nivolumab
MH  - Quality of Life
MH  - Young Adult
PMC - PMC5896687
OTO - NOTNLM
OT  - Japanese
OT  - everolimus
OT  - immune checkpoint inhibitor
OT  - nivolumab
OT  - renal cell carcinoma
EDAT- 2017/04/19 06:00
MHDA- 2017/12/06 06:00
PMCR- 2017/04/13
CRDT- 2017/04/19 06:00
PHST- 2017/01/17 00:00 [received]
PHST- 2017/04/03 00:00 [accepted]
PHST- 2017/04/19 06:00 [pubmed]
PHST- 2017/12/06 06:00 [medline]
PHST- 2017/04/19 06:00 [entrez]
PHST- 2017/04/13 00:00 [pmc-release]
AID - 3610974 [pii]
AID - hyx049 [pii]
AID - 10.1093/jjco/hyx049 [doi]
PST - ppublish
SO  - Jpn J Clin Oncol. 2017 Jul 1;47(7):639-646. doi: 10.1093/jjco/hyx049.