PMID- 32489505
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220414
IS  - 1918-3003 (Print)
IS  - 1918-3011 (Electronic)
IS  - 1918-3003 (Linking)
VI  - 12
IP  - 5
DP  - 2020 May
TI  - Treating Japanese Patients With Pembrolizumab for Platinum-Refractory Advanced 
      Urothelial Carcinoma in Real-World Clinical Practice.
PG  - 300-306
LID - 10.14740/jocmr4162 [doi]
AB  - BACKGROUND: Since December 2017, pembrolizumab has been approved in Japan as a 
      second-line treatment for radical unresectable urothelial carcinoma (UC) that has 
      become exacerbated after chemotherapy by the international randomized phase 3 
      trial, KEYNOTE-045. The aim of this study was to evaluate the oncological 
      efficacy and safety of pembrolizumab after failure of platinum-based chemotherapy 
      in Japanese patients with advanced UC in real-world clinical practice. METHODS: A 
      total of 34 patients who received pembrolizumab after the failure of 
      platinum-based chemotherapy for advanced urothelial carcinoma at four 
      institutions between January 2018 and August 2019 were retrospectively evaluated. 
      In all patients, UC was histopathologically diagnosed, and disease progression 
      after platinum-based chemotherapy was radiologically confirmed. RESULTS: The 
      median follow-up period was 7.7 months. The objective response rate, median 
      progression-free survival, and median overall survival were 20.6%, 3.3 months, 
      and 11.7 months, respectively. Regarding the toxicities associated with 
      pembrolizumab, adverse events (AEs) of any grade occurred in 61.8%, and grade 3 
      AEs occurred in 23.5%; grade >/= 4 AEs did not occur in any patients. Univariate 
      analyses revealed that the Eastern Cooperative Oncology Group Performance Status, 
      neutrophil/lymphocyte ratio, liver metastases, and time from previous 
      chemotherapy were prognostic variables. Multivariate analyses revealed that liver 
      metastases (positive: hazard ratio, 4.23; 95% confidence interval, 1.48 - 12.08; 
      P < 0.01) and time from previous chemotherapy (>/= 3 months: hazard ratio, 5.06; 
      95% confidence interval, 1.43 - 17.91; P = 0.01) were independent prognostic 
      factors. CONCLUSIONS: In this real-world clinical study, these findings 
      concerning the efficacy and safety of pembrolizumab for advanced UC in Japanese 
      patients were comparable to those of the open-label, international, phase 3 trial 
      KEYNOTE-045. Liver metastases and time from previous chemotherapy were 
      independent prognostic factors in the present study.
CI  - Copyright 2020, Furubayashi et al.
FAU - Furubayashi, Nobuki
AU  - Furubayashi N
AD  - Department of Urology, National Hospital Organization Kyushu Cancer Center, 
      Fukuoka, Japan.
FAU - Kuroiwa, Kentaro
AU  - Kuroiwa K
AD  - Department of Urology, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.
FAU - Tokuda, Noriaki
AU  - Tokuda N
AD  - Department of Urology, Saga-ken Medical Centre Koseikan, Saga, Japan.
FAU - Tomoda, Toshihisa
AU  - Tomoda T
AD  - Department of Urology, Oita Prefectural Hospital, Oita, Japan.
FAU - Morokuma, Futoshi
AU  - Morokuma F
AD  - Department of Urology, Saga-ken Medical Centre Koseikan, Saga, Japan.
FAU - Hori, Yoshifumi
AU  - Hori Y
AD  - Department of Urology, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.
FAU - Negishi, Takahito
AU  - Negishi T
AD  - Department of Urology, National Hospital Organization Kyushu Cancer Center, 
      Fukuoka, Japan.
FAU - Inoue, Tomohiro
AU  - Inoue T
AD  - Department of Urology, National Hospital Organization Kyushu Cancer Center, 
      Fukuoka, Japan.
FAU - Kumagai, Masatoshi
AU  - Kumagai M
AD  - Department of Urology, National Hospital Organization Kyushu Cancer Center, 
      Fukuoka, Japan.
FAU - Nakamura, Motonobu
AU  - Nakamura M
AD  - Department of Urology, National Hospital Organization Kyushu Cancer Center, 
      Fukuoka, Japan.
LA  - eng
PT  - Journal Article
DEP - 20200508
PL  - Canada
TA  - J Clin Med Res
JT  - Journal of clinical medicine research
JID - 101538301
PMC - PMC7239584
OTO - NOTNLM
OT  - Advanced urothelial carcinoma
OT  - Japanese
OT  - Pembrolizumab
OT  - Platinum-refractory
OT  - Real-world clinical practice
COIS- The authors declare that they have no conflict of interest for this study.
EDAT- 2020/06/04 06:00
MHDA- 2020/06/04 06:01
PMCR- 2020/05/08
CRDT- 2020/06/04 06:00
PHST- 2020/04/10 00:00 [received]
PHST- 2020/04/21 00:00 [accepted]
PHST- 2020/06/04 06:00 [entrez]
PHST- 2020/06/04 06:00 [pubmed]
PHST- 2020/06/04 06:01 [medline]
PHST- 2020/05/08 00:00 [pmc-release]
AID - 10.14740/jocmr4162 [doi]
PST - ppublish
SO  - J Clin Med Res. 2020 May;12(5):300-306. doi: 10.14740/jocmr4162. Epub 2020 May 8.