PMID- 32517311
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 9
IP  - 6
DP  - 2020 Jun 7
TI  - Efficacy and Safety of Pembrolizumab for Gemcitabine/Cisplatin-Refractory Biliary 
      Tract Cancer: A Multicenter Retrospective Study.
LID - 10.3390/jcm9061769 [doi]
LID - 1769
AB  - Pembrolizumab, an anti-programmed cell death (PD)-1 monoclonal antibody, is an 
      anticancer agent showing substantial benefit in lung cancer and melanoma 
      treatment. Biliary tract cancer (BTC) has been shown to respond to pembrolizumab; 
      however, no credible data of such treatment outcomes exist. Therefore, we 
      assessed the clinical outcomes and safety of pembrolizumab in patients with 
      gemcitabine/cisplatin-refractory BTC. In this multicenter study, we 
      retrospectively analyzed 51 patients with programmed cell death 1-ligand 1 
      (PD-L1)-positive gemcitabine/cisplatin-refractory BTC treated with pembrolizumab 
      in four tertiary hospitals in Korea. PD-L1 positivity was defined as the 
      expression of PD-L1 in >/=1% of tumor cells based on immunohistochemical staining 
      (22C3, SP263, and E1L3N assays). The median age of the patients was 66 (range, 
      43-83) years and 29 (56.9%) were male. Extrahepatic cholangiocarcinoma was the 
      most common cancer type (n = 30, 58.8%). Partial response and stable disease were 
      achieved in 5 (9.8%) and 13 (25.5%) patients, respectively. Median 
      progression-free survival and overall survival were 2.1 (95% CI, 1.7-2.4) and 6.9 
      (95% CI, 5.4-8.3) months, respectively. Overall, 30 (58.8%) patients experienced 
      treatment-related adverse events (AEs). Only four (7.8%) patients experienced 
      grades 3 and 4 AEs. In PD-L1-positive gemcitabine/cisplatin-refractory BTC, 
      pembrolizumab presented durable efficacy, with a 9.8% response rate and 
      manageable toxicity.
FAU - Lee, Sang Hoon
AU  - Lee SH
AUID- ORCID: 0000-0002-3619-4340
AD  - Department of Internal medicine, Severance Hospital, Yonsei University College of 
      Medicine, Seoul 03772, Korea.
AD  - Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal 
      Cancer, Seoul 03741, Korea.
AD  - Digestive Disease Center, Department of Internal Medicine, Konkuk University 
      Medical Center, Konkuk University School of Medicine, Seoul 05030, Korea.
FAU - Lee, Hee Seung
AU  - Lee HS
AD  - Department of Internal medicine, Severance Hospital, Yonsei University College of 
      Medicine, Seoul 03772, Korea.
AD  - Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal 
      Cancer, Seoul 03741, Korea.
FAU - Lee, Sang Hyub
AU  - Lee SH
AD  - Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal 
      Cancer, Seoul 03741, Korea.
AD  - Department of Internal medicine and Liver Research Institute, Seoul National 
      University Hospital, Seoul National University College of Medicine, Seoul 03080, 
      Korea.
FAU - Woo, Sang Myung
AU  - Woo SM
AUID- ORCID: 0000-0003-3786-4403
AD  - Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal 
      Cancer, Seoul 03741, Korea.
AD  - Center for Liver and Pancreaticobiliary Cancer, National Cancer Center, Goyang 
      10408, Korea.
FAU - Kim, Dong Uk
AU  - Kim DU
AD  - Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal 
      Cancer, Seoul 03741, Korea.
AD  - Biomedical Institute, Pusan National University Hospital, Busan 49241, Korea.
FAU - Bang, Seungmin
AU  - Bang S
AD  - Department of Internal medicine, Severance Hospital, Yonsei University College of 
      Medicine, Seoul 03772, Korea.
AD  - Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal 
      Cancer, Seoul 03741, Korea.
LA  - eng
PT  - Journal Article
DEP - 20200607
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC7355970
OTO - NOTNLM
OT  - PD-L1 costimulatory protein
OT  - biliary tract neoplasm
OT  - biomarker
OT  - cholangiocarcinoma
OT  - immunotherapy
COIS- The authors declare no conflicts of interest.
EDAT- 2020/06/11 06:00
MHDA- 2020/06/11 06:01
PMCR- 2020/06/07
CRDT- 2020/06/11 06:00
PHST- 2020/05/07 00:00 [received]
PHST- 2020/05/26 00:00 [revised]
PHST- 2020/06/03 00:00 [accepted]
PHST- 2020/06/11 06:00 [entrez]
PHST- 2020/06/11 06:00 [pubmed]
PHST- 2020/06/11 06:01 [medline]
PHST- 2020/06/07 00:00 [pmc-release]
AID - jcm9061769 [pii]
AID - jcm-09-01769 [pii]
AID - 10.3390/jcm9061769 [doi]
PST - epublish
SO  - J Clin Med. 2020 Jun 7;9(6):1769. doi: 10.3390/jcm9061769.