| Autor: |
Lee SH; Department of Internal medicine, Severance Hospital, Yonsei University College of Medicine, Seoul 03772, Korea.; Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer, Seoul 03741, Korea.; Digestive Disease Center, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul 05030, Korea., Lee HS; Department of Internal medicine, Severance Hospital, Yonsei University College of Medicine, Seoul 03772, Korea.; Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer, Seoul 03741, Korea., Lee SH; Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer, Seoul 03741, Korea.; Department of Internal medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul 03080, Korea., Woo SM; Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer, Seoul 03741, Korea.; Center for Liver and Pancreaticobiliary Cancer, National Cancer Center, Goyang 10408, Korea., Kim DU; Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer, Seoul 03741, Korea.; Biomedical Institute, Pusan National University Hospital, Busan 49241, Korea., Bang S; Department of Internal medicine, Severance Hospital, Yonsei University College of Medicine, Seoul 03772, Korea.; Pancreaticobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer, Seoul 03741, Korea. |
| Abstrakt: |
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. |
