PMID- 33934570
OWN - NLM
STAT- MEDLINE
DCOM- 20220307
LR  - 20220307
IS  - 2573-8348 (Electronic)
IS  - 2573-8348 (Linking)
VI  - 4
IP  - 6
DP  - 2021 Dec
TI  - Effectiveness and safety profile of pembrolizumab for metastatic urothelial 
      cancer: A retrospective single-center analysis in Japan.
PG  - e1398
LID - 10.1002/cnr2.1398 [doi]
LID - e1398
AB  - BACKGROUND: The paradigm of medical treatment for metastatic urothelial carcinoma 
      is dramatically changing through the introduction of pembrolizumab. AIM: We 
      investigated the treatment effectiveness, the safety profile, and the prognostic 
      factors of pembrolizumab in Japanese real-world clinical practice. METHODS AND 
      RESULTS: The medical records of 74 consecutive Japanese patients with metastatic 
      urothelial cancer (UC), who started pembrolizumab as a second- or later-line 
      treatment at our institution between January 2018 and March 2020, were reviewed 
      and statistically analyzed. The median follow-up period after initiation of 
      pembrolizumab was 8.5 (interquartile range: 3.5-15.7) months. The objective 
      response rate was 30.2%, the median progression-free survival period was 
      4.9 months, and the median overall survival (OS) period was 13.3 months. 
      Evaluation revealed that 39 (52.9%) patients experienced adverse events (AEs), 
      among whom eight patients (10.9%) had severe AEs (grade 3 or more), including 
      grade 5 hemophagocytic syndrome. Multivariate analysis indicated that the 
      presence of liver metastasis, worse performance status (>/=2), elevated serum 
      lactate dehydrogenase, and increased C-reactive protein were predictive of 
      shorter OS. CONCLUSION: We studied the effectiveness and safety profile of 
      pembrolizumab therapy in Japanese UC patients. We believe that the data presented 
      here will be useful for clinical physicians.
CI  - (c) 2021 The Authors. Cancer Reports published by Wiley Periodicals LLC.
FAU - Fujiwara, Motohiro
AU  - Fujiwara M
AUID- ORCID: 0000-0001-9454-3345
AD  - Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer 
      Research, Tokyo, Japan.
FAU - Yuasa, Takeshi
AU  - Yuasa T
AUID- ORCID: 0000-0002-8924-6730
AD  - Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer 
      Research, Tokyo, Japan.
FAU - Urasaki, Tetsuya
AU  - Urasaki T
AD  - Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation 
      for Cancer Research, Tokyo, Japan.
FAU - Komai, Yoshinobu
AU  - Komai Y
AUID- ORCID: 0000-0003-0353-9303
AD  - Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer 
      Research, Tokyo, Japan.
FAU - Fujiwara, Ryo
AU  - Fujiwara R
AUID- ORCID: 0000-0001-6566-1430
AD  - Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer 
      Research, Tokyo, Japan.
FAU - Numao, Noboru
AU  - Numao N
AD  - Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer 
      Research, Tokyo, Japan.
FAU - Yamamoto, Shinya
AU  - Yamamoto S
AD  - Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer 
      Research, Tokyo, Japan.
FAU - Yonese, Junji
AU  - Yonese J
AD  - Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer 
      Research, Tokyo, Japan.
LA  - eng
GR  - 16K11035/Smoking Research Foundation/
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210502
PL  - United States
TA  - Cancer Rep (Hoboken)
JT  - Cancer reports (Hoboken, N.J.)
JID - 101747728
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immune Checkpoint Inhibitors)
RN  - DPT0O3T46P (pembrolizumab)
SB  - IM
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Carcinoma, Transitional Cell/*drug therapy/secondary
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immune Checkpoint Inhibitors/*therapeutic use
MH  - Liver Neoplasms/*drug therapy/secondary
MH  - Lymphatic Metastasis
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Retrospective Studies
MH  - Survival Rate
MH  - Urinary Bladder Neoplasms/*drug therapy/pathology
PMC - PMC8714548
OTO - NOTNLM
OT  - immune checkpoint inhibitor
OT  - immune-related adverse events
OT  - pembrolizumab
OT  - prognostic factor
OT  - urothelial carcinoma
COIS- T.Y received remuneration for lectures from MSD Japan (Tokyo, Japan). The other 
      authors declare that they have no conflicts of interest that might be relevant to 
      the contents of this manuscript.
EDAT- 2021/05/03 06:00
MHDA- 2022/03/08 06:00
PMCR- 2021/05/02
CRDT- 2021/05/02 21:28
PHST- 2021/03/03 00:00 [revised]
PHST- 2021/01/07 00:00 [received]
PHST- 2021/03/25 00:00 [accepted]
PHST- 2021/05/03 06:00 [pubmed]
PHST- 2022/03/08 06:00 [medline]
PHST- 2021/05/02 21:28 [entrez]
PHST- 2021/05/02 00:00 [pmc-release]
AID - CNR21398 [pii]
AID - 10.1002/cnr2.1398 [doi]
PST - ppublish
SO  - Cancer Rep (Hoboken). 2021 Dec;4(6):e1398. doi: 10.1002/cnr2.1398. Epub 2021 May 
      2.