PMID- 28342215
OWN - NLM
STAT- MEDLINE
DCOM- 20170915
LR  - 20221207
IS  - 1349-7006 (Electronic)
IS  - 1347-9032 (Print)
IS  - 1347-9032 (Linking)
VI  - 108
IP  - 6
DP  - 2017 Jun
TI  - Efficacy and safety of nivolumab in Japanese patients with previously untreated 
      advanced melanoma: A phase II study.
PG  - 1223-1230
LID - 10.1111/cas.13241 [doi]
AB  - Treating advanced or recurrent melanoma remains a challenge. Cancer cells can 
      evade the immune system by blocking T-cell activation through overexpression of 
      the inhibitory receptor programmed death 1 (PD-1) ligands. The PD-1 inhibitor 
      nivolumab blocks the inhibitory signal in T cells, thus overcoming the immune 
      resistance of cancer cells. Nivolumab has shown promising anticancer activity in 
      various cancers. We carried out a single-arm, open-label, multicenter, phase II 
      study to investigate the efficacy and safety of nivolumab in previously untreated 
      Japanese patients with advanced melanoma. Twenty-four patients with stage III/IV 
      or recurrent melanoma were enrolled and received i.v. nivolumab 3 mg/kg every 2 
      weeks until disease progression or unacceptable toxicity. The primary endpoint 
      was overall response rate evaluated by an independent radiology review committee. 
      The independent radiology review committee-assessed overall response rate was 
      34.8% (90% confidence interval, 20.8-51.9), and the overall survival rate at 18 
      months was 56.5% (90% confidence interval, 38.0-71.4). Treatment-related adverse 
      events (AEs) of grade 3 or 4 only occurred in three patients (12.5%). Two 
      patients discontinued nivolumab because of AEs, but all AEs were considered 
      manageable by early diagnosis and appropriate treatment. Subgroup analyses showed 
      that nivolumab was clinically beneficial and tolerable regardless of BRAF 
      genotype, and that patients with treatment-related select AEs and with vitiligo 
      showed tendency for better survival. In conclusion, nivolumab showed favorable 
      efficacy and safety profiles in Japanese patients with advanced or recurrent 
      melanoma, with or without BRAF mutations. (Trial registration no. 
      JapicCTI-142533.).
CI  - (c) 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd 
      on behalf of Japanese Cancer Association.
FAU - Yamazaki, Naoya
AU  - Yamazaki N
AUID- ORCID: 0000-0002-9638-0428
AD  - Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, 
      Japan.
FAU - Kiyohara, Yoshio
AU  - Kiyohara Y
AD  - Dermatology Division, Shizuoka Cancer Center Hospital, Shizuoka, Japan.
FAU - Uhara, Hisashi
AU  - Uhara H
AD  - Department of Dermatology, Shinshu University School of Medicine, Nagano, Japan.
FAU - Uehara, Jiro
AU  - Uehara J
AD  - Department of Dermatology, Asahikawa Medical University, Hokkaido, Japan.
FAU - Fujimoto, Manabu
AU  - Fujimoto M
AD  - Department of Dermatology, University of Tsukuba Hospital, Ibaraki, Japan.
FAU - Takenouchi, Tatsuya
AU  - Takenouchi T
AD  - Department of Dermatology, Niigata Cancer Center Hospital, Niigata, Japan.
FAU - Otsuka, Masaki
AU  - Otsuka M
AD  - Department of Dermatology, Okayama University Graduate School of Medicine, 
      Dentistry and Pharmaceutical Sciences, Okayama, Japan.
FAU - Uchi, Hiroshi
AU  - Uchi H
AD  - Department of Dermatology, Graduate School of Medical Sciences, Kyushu 
      University, Fukuoka, Japan.
FAU - Ihn, Hironobu
AU  - Ihn H
AD  - Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto 
      University, Kumamoto, Japan.
FAU - Minami, Hironobu
AU  - Minami H
AD  - Department Medical Oncology/Hematology, Kobe University Graduate School of 
      Medicine, Hyogo, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170615
PL  - England
TA  - Cancer Sci
JT  - Cancer science
JID - 101168776
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - 31YO63LBSN (Nivolumab)
RN  - EC 2.7.11.1 (Proto-Oncogene Proteins B-raf)
SB  - IM
MH  - Aged
MH  - Antibodies, Monoclonal/*adverse effects/*therapeutic use
MH  - Antineoplastic Agents/*adverse effects/*therapeutic use
MH  - Asian People
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Male
MH  - Melanoma/*drug therapy/metabolism
MH  - Neoplasm Recurrence, Local/drug therapy/metabolism
MH  - Nivolumab
MH  - Proto-Oncogene Proteins B-raf/metabolism
MH  - Survival Rate
PMC - PMC5480079
OTO - NOTNLM
OT  - Immune checkpoint inhibitor
OT  - Japanese patients
OT  - melanoma
OT  - nivolumab
OT  - programmed death 1 (PD-1) inhibitor
EDAT- 2017/03/28 06:00
MHDA- 2017/09/16 06:00
PMCR- 2017/06/01
CRDT- 2017/03/26 06:00
PHST- 2017/01/16 00:00 [received]
PHST- 2017/02/28 00:00 [revised]
PHST- 2017/03/02 00:00 [accepted]
PHST- 2017/03/28 06:00 [pubmed]
PHST- 2017/09/16 06:00 [medline]
PHST- 2017/03/26 06:00 [entrez]
PHST- 2017/06/01 00:00 [pmc-release]
AID - CAS13241 [pii]
AID - 10.1111/cas.13241 [doi]
PST - ppublish
SO  - Cancer Sci. 2017 Jun;108(6):1223-1230. doi: 10.1111/cas.13241. Epub 2017 Jun 15.