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Efficacy and Safety of Pembrolizumab for Gemcitabine/Cisplatin-Refractory Biliary Tract Cancer: A Multicenter Retrospective Study

Authors
 Sang Hoon Lee  ;  Hee Seung Lee  ;  Sang Hyub Lee  ;  Sang Myung Woo  ;  Dong Uk Kim  ;  Seungmin Bang 
Citation
 JOURNAL OF CLINICAL MEDICINE, Vol.9(6) : 1769, 2020-06 
Journal Title
 JOURNAL OF CLINICAL MEDICINE 
Issue Date
2020-06
Keywords
PD-L1 costimulatory protein ; biliary tract neoplasm ; biomarker ; cholangiocarcinoma ; immunotherapy
Abstract
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.
Files in This Item:
T202002344.pdf Download
DOI
10.3390/jcm9061769
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Lee, Sang Hoon(이상훈B) ORCID logo https://orcid.org/0000-0002-3619-4340
Lee, Hee Seung(이희승) ORCID logo https://orcid.org/0000-0002-2825-3160
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/179366
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