Research status and prospect of immunotherapy for biliary malignancy_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

DAI Dongdong ¹ ,  YIN Shuan ^1,2

1. Department of Hepatobiliary Surgery , The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266000, P. R. China;
2. Department of Pediatrics, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266000, P. R. China;

Corresponding author：

YIN Shuan, Email: yinshuan057@126.com

Keywords：

Malignant tumor of bile duct; biliary tract cancer; immunotherapy; immune checkpoint inhibitors; research progress

DOI：

10.7507/1007-9424.202105039

Video：

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Objective To summarize the research status and prospect of immunotherapy for biliary tract cancer (BTC). Method The literatures about immunotherapy of BTC at home and abroad in recent years were reviewed. Results Surgical resection was still the first choice and only radical treatment for BTC. However, the recurrence rate of BTC was high, and most of the patients were in the middle and late stage with metastasis and lose the opportunity of operation. Patients with local progression, metastasis or recurrence could only receive chemotherapy and other comprehensive treatment, but they could not get satisfactory results. The continuous update of targeted drugs brings new hope for drug therapy of BTC, and immunotherapy had become a new treatment of tumor targeted therapy following radiotherapy and chemotherapy. Conclusion Immunotherapy can be used as an option for the treatment of advanced BTC and its postoperative recurrence and metastasis, and has attracted more and more attention.

Citation： DAI Dongdong, YIN Shuan. Research status and prospect of immunotherapy for biliary malignancy. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2022, 29(3): 410-414. doi: 10.7507/1007-9424.202105039 Copy

1.	Rizvi S, Gores GJ. Pathogenesis, diagnosis, and management of cholangiocarcinoma. Gastroenterology, 2013, 145(6): 1215-1229.
2.	Labib PL, Goodchild G, Pereira SP. Molecular pathogenesis of cholangiocarcinoma. BMC Cancer, 2019, 19(1): 185. doi: 10.1186/s12885-019-5391-0.
3.	Bergquist A, von Seth E. Epidemiology of cholangiocarcinoma. Best Pract Res Clin Gastroenterol, 2015, 29(2): 221-232.
4.	Morizane C, Ueno M, Ikeda M, et al. New developments in systemic therapy for advanced biliary tract cancer. Jpn J Clin Oncol, 2018, 48(8): 703-711.
5.	Bréchon M, Dior M, Dréanic J, et al. Addition of an antiangiogenic therapy, bevacizumab, to gemcitabine plus oxaliplatin improves survival in advanced biliary tract cancers. Invest New Drugs, 2018, 36(1): 156-162.
6.	Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med, 2015, 373(17): 1627-1639.
7.	Sabbatino F, Villani V, Yearley JH, et al. PD-L1 and HLA class Ⅰ antigen expression and clinical course of the disease in intrahepatic cholangiocarcinoma. Clin Cancer Res, 2016, 22(2): 470-478.
8.	Fuchs CS, Doi T, Jang RW, et al. Safety and efficacy of pembrolizumab monotherapy in patients with previously treated advanced gastric and gastroesophageal junction cancer: phase 2 clinical KEYNOTE-059 trial. JAMA Oncol, 2018, 4(5): e180013. doi: 10.1001/jamaoncol.2018.0013.
9.	Piha-Paul SA, Oh DY, Ueno M, et al. Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies. Int J Cancer, 2020, 147(8): 2190-2198.
10.	Doi T, Piha-Paul SA, Jalal SI, et al. Safety and antitumor activity of the anti-programmed death-1 antibody pembrolizumab in patients with advanced esophageal carcinoma. J Clin Oncol, 2018, 36(1): 61-67.
11.	Kim RD, Chung V, Alese OB, et al. A phase 2 multi-institutional study of nivolumab for patients with advanced refractory biliary tract cancer. JAMA Oncol, 2020, 6(6): 888-894.
12.	Czink E, Kloor M, Goeppert B, et al. Successful immune checkpoint blockade in a patient with advanced stage microsatellite-unstable biliary tract cancer. Cold Spring Harb Mol Case Stud, 2017, 3(5): a001974. doi: 10.1101/mcs.a001974. Print 2017 Sep.
13.	Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med, 2015, 372(26): 2509-2520.
14.	Lim YJ, Koh J, Kim K, et al. Clinical implications of cytotoxic t lymphocyte antigen-4 expression on tumor cells and tumor-infiltrating lymphocytes in extrahepatic bile duct cancer patients undergoing surgery plus adjuvant chemoradiotherapy. Target Oncol, 2017, 12(2): 211-218.
15.	Wang Z, Cao YJ. Adoptive cell therapy targeting neoantigens: a frontier for cancer research. Front Immunol, 2020, 11: 176. doi: 10.3389/fimmu.2020.00176.
16.	Tran E, Turcotte S, Gros A, et al. Cancer immunotherapy based on mutation-specific CD4⁺ T cells in a patient with epithelial cancer. Science, 2014, 344(6184): 641-645.
17.	Bielamowicz K, Fousek K, Byrd TT, et al. Trivalent CAR T cells overcome interpatient antigenic variability in glioblastoma. Neuro Oncol, 2018, 20(4): 506-518.
18.	Feng KC, Guo YL, Liu Y, et al. Cocktail treatment with EGFR-specific and CD133-specific chimeric antigen receptor-modified T cells in a patient with advanced cholangiocarcinoma. J Hematol Oncol, 2017, 10(1): 4. doi: 10.1186/s13045-016-0378-7.
19.	Marks EI, Yee NS. Immunotherapeutic approaches in biliary tract carcinoma: Current status and emerging strategies. World J Gastrointest Oncol, 2015, 7(11): 338-346.
20.	Nakatsuka S, Oji Y, Horiuchi T, et al. Immunohistochemical detection of WT1 protein in a variety of cancer cells. Mod Pathol, 2006, 19(6): 804-814.
21.	Park SY, Roh SJ, Kim YN, et al. Expression of MUC1, MUC2, MUC5AC and MUC6 in cholangiocarcinoma: prognostic impact. Oncol Rep, 2009, 22(3): 649-657.
22.	Kaida M, Morita-Hoshi Y, Soeda A, et al. Phase 1 trial of Wilms tumor 1 (WT1) peptide vaccine and gemcitabine combination therapy in patients with advanced pancreatic or biliary tract cancer. J Immunother, 2011, 34(1): 92-99.
23.	Aruga A, Takeshita N, Kotera Y, et al. Phase Ⅰ clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer. J Transl Med, 2014, 12: 61. doi: 10.1186/1479-5876-12-61.
24.	Kobayashi M, Sakabe T, Abe H, et al. Dendritic cell-based immunotherapy targeting synthesized peptides for advanced biliary tract cancer. J Gastrointest Surg, 2013, 17(9): 1609-1617.
25.	Li H, Qin S, Liu Y, et al. Camrelizumab combined with FOLFOX4 regimen as first-line therapy for advanced hepatocellular carcinomas: A sub-cohort of a multicenter phase Ⅰb/Ⅱ study. Drug Des Devel Ther, 2021, 15: 1873-1882.
26.	Liu X, Yao J, Song L, et al. Local and abscopal responses in advanced intrahepatic cholangiocarcinoma with low TMB, MSS, pMMR and negative PD-L1 expression following combined therapy of SBRT with PD-1 blockade. J Immunother Cancer, 2019, 7(1): 204. doi: 10.1186/s40425-019-0692-z.
27.	Simone V, Brunetti O, Lupo L, et al. Targeting angiogenesis in biliary tract cancers: An open option. Int J Mol Sci, 2017, 18(2): 418. doi: 10.3390/ijms18020418.
28.	Sun W, Patel A, Normolle D, et al. A phase 2 trial of regorafenib as a single agent in patients with chemotherapy-refractory, advanced, and metastatic biliary tract adenocarcinoma. Cancer, 2019, 125(6): 902-909.
29.	Arkenau HT, Martin-Liberal J, Calvo E, et al. Ramucirumab plus pembrolizumab in patients with previously treated advanced or metastatic biliary tract cancer: nonrandomized, open-label, phase i trial (JVDF). Oncologist, 2018, 23(12): 1407-e136. doi: 10.1634/theoncologist.2018-0044.

1. Rizvi S, Gores GJ. Pathogenesis, diagnosis, and management of cholangiocarcinoma. Gastroenterology, 2013, 145(6): 1215-1229.
2. Labib PL, Goodchild G, Pereira SP. Molecular pathogenesis of cholangiocarcinoma. BMC Cancer, 2019, 19(1): 185. doi: 10.1186/s12885-019-5391-0.
3. Bergquist A, von Seth E. Epidemiology of cholangiocarcinoma. Best Pract Res Clin Gastroenterol, 2015, 29(2): 221-232.
4. Morizane C, Ueno M, Ikeda M, et al. New developments in systemic therapy for advanced biliary tract cancer. Jpn J Clin Oncol, 2018, 48(8): 703-711.
5. Bréchon M, Dior M, Dréanic J, et al. Addition of an antiangiogenic therapy, bevacizumab, to gemcitabine plus oxaliplatin improves survival in advanced biliary tract cancers. Invest New Drugs, 2018, 36(1): 156-162.
6. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med, 2015, 373(17): 1627-1639.
7. Sabbatino F, Villani V, Yearley JH, et al. PD-L1 and HLA class Ⅰ antigen expression and clinical course of the disease in intrahepatic cholangiocarcinoma. Clin Cancer Res, 2016, 22(2): 470-478.
8. Fuchs CS, Doi T, Jang RW, et al. Safety and efficacy of pembrolizumab monotherapy in patients with previously treated advanced gastric and gastroesophageal junction cancer: phase 2 clinical KEYNOTE-059 trial. JAMA Oncol, 2018, 4(5): e180013. doi: 10.1001/jamaoncol.2018.0013.
9. Piha-Paul SA, Oh DY, Ueno M, et al. Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies. Int J Cancer, 2020, 147(8): 2190-2198.
10. Doi T, Piha-Paul SA, Jalal SI, et al. Safety and antitumor activity of the anti-programmed death-1 antibody pembrolizumab in patients with advanced esophageal carcinoma. J Clin Oncol, 2018, 36(1): 61-67.
11. Kim RD, Chung V, Alese OB, et al. A phase 2 multi-institutional study of nivolumab for patients with advanced refractory biliary tract cancer. JAMA Oncol, 2020, 6(6): 888-894.
12. Czink E, Kloor M, Goeppert B, et al. Successful immune checkpoint blockade in a patient with advanced stage microsatellite-unstable biliary tract cancer. Cold Spring Harb Mol Case Stud, 2017, 3(5): a001974. doi: 10.1101/mcs.a001974. Print 2017 Sep.
13. Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med, 2015, 372(26): 2509-2520.
14. Lim YJ, Koh J, Kim K, et al. Clinical implications of cytotoxic t lymphocyte antigen-4 expression on tumor cells and tumor-infiltrating lymphocytes in extrahepatic bile duct cancer patients undergoing surgery plus adjuvant chemoradiotherapy. Target Oncol, 2017, 12(2): 211-218.
15. Wang Z, Cao YJ. Adoptive cell therapy targeting neoantigens: a frontier for cancer research. Front Immunol, 2020, 11: 176. doi: 10.3389/fimmu.2020.00176.
16. Tran E, Turcotte S, Gros A, et al. Cancer immunotherapy based on mutation-specific CD4⁺ T cells in a patient with epithelial cancer. Science, 2014, 344(6184): 641-645.
17. Bielamowicz K, Fousek K, Byrd TT, et al. Trivalent CAR T cells overcome interpatient antigenic variability in glioblastoma. Neuro Oncol, 2018, 20(4): 506-518.
18. Feng KC, Guo YL, Liu Y, et al. Cocktail treatment with EGFR-specific and CD133-specific chimeric antigen receptor-modified T cells in a patient with advanced cholangiocarcinoma. J Hematol Oncol, 2017, 10(1): 4. doi: 10.1186/s13045-016-0378-7.
19. Marks EI, Yee NS. Immunotherapeutic approaches in biliary tract carcinoma: Current status and emerging strategies. World J Gastrointest Oncol, 2015, 7(11): 338-346.
20. Nakatsuka S, Oji Y, Horiuchi T, et al. Immunohistochemical detection of WT1 protein in a variety of cancer cells. Mod Pathol, 2006, 19(6): 804-814.
21. Park SY, Roh SJ, Kim YN, et al. Expression of MUC1, MUC2, MUC5AC and MUC6 in cholangiocarcinoma: prognostic impact. Oncol Rep, 2009, 22(3): 649-657.
22. Kaida M, Morita-Hoshi Y, Soeda A, et al. Phase 1 trial of Wilms tumor 1 (WT1) peptide vaccine and gemcitabine combination therapy in patients with advanced pancreatic or biliary tract cancer. J Immunother, 2011, 34(1): 92-99.
23. Aruga A, Takeshita N, Kotera Y, et al. Phase Ⅰ clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer. J Transl Med, 2014, 12: 61. doi: 10.1186/1479-5876-12-61.
24. Kobayashi M, Sakabe T, Abe H, et al. Dendritic cell-based immunotherapy targeting synthesized peptides for advanced biliary tract cancer. J Gastrointest Surg, 2013, 17(9): 1609-1617.
25. Li H, Qin S, Liu Y, et al. Camrelizumab combined with FOLFOX4 regimen as first-line therapy for advanced hepatocellular carcinomas: A sub-cohort of a multicenter phase Ⅰb/Ⅱ study. Drug Des Devel Ther, 2021, 15: 1873-1882.
26. Liu X, Yao J, Song L, et al. Local and abscopal responses in advanced intrahepatic cholangiocarcinoma with low TMB, MSS, pMMR and negative PD-L1 expression following combined therapy of SBRT with PD-1 blockade. J Immunother Cancer, 2019, 7(1): 204. doi: 10.1186/s40425-019-0692-z.
27. Simone V, Brunetti O, Lupo L, et al. Targeting angiogenesis in biliary tract cancers: An open option. Int J Mol Sci, 2017, 18(2): 418. doi: 10.3390/ijms18020418.
28. Sun W, Patel A, Normolle D, et al. A phase 2 trial of regorafenib as a single agent in patients with chemotherapy-refractory, advanced, and metastatic biliary tract adenocarcinoma. Cancer, 2019, 125(6): 902-909.
29. Arkenau HT, Martin-Liberal J, Calvo E, et al. Ramucirumab plus pembrolizumab in patients with previously treated advanced or metastatic biliary tract cancer: nonrandomized, open-label, phase i trial (JVDF). Oncologist, 2018, 23(12): 1407-e136. doi: 10.1634/theoncologist.2018-0044.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Research status and prospect of immunotherapy for biliary malignancy

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