Valle JW, Kelley RK, Nervi B, et al. Biliary tract cancer. Lancet. 2021;397(10272):428–44.

Article  CAS  PubMed  Google Scholar 

Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(2):127–40.

Article  CAS  PubMed  Google Scholar 

Roth GS, Neuzillet C, Sarabi M, et al. Cholangiocarcinoma: what are the options in all comers and how has the advent of molecular profiling opened the way to personalised medicine? Eur J Cancer. 2023;179:1–14.

Article  CAS  PubMed  Google Scholar 

Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362(14):1273–81.

Article  CAS  PubMed  Google Scholar 

Okusaka T, Nakachi K, Fukutomi A, et al. Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan. Br J Cancer. 2010;103(4):469–74.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kim BJ, Hyung J, Yoo C, et al. Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients. Cancer Chemother Pharmacol. 2017;80(1):209–15.

Article  CAS  PubMed  Google Scholar 

Ma K, Wei X, Dong D, et al. PD-L1 and PD-1 expression correlate with prognosis in extrahepatic cholangiocarcinoma. Oncol Lett. 2017;14(1):250–6.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Luo Q, Zhang L, Luo C, et al. Emerging strategies in cancer therapy combining chemotherapy with immunotherapy. Cancer Lett. 2019;454:191–203.

Article  CAS  PubMed  Google Scholar 

Stewart R, Morrow M, Hammond SA, et al. Identification and characterization of MEDI4736, an antagonistic anti-PD-L1 monoclonal antibody. Cancer Immunol Res. 2015;3(9):1052–62.

Article  CAS  PubMed  Google Scholar 

AstraZeneca Pharmaceuticals LP. IMFINZI® (durvalumab) injection, for intravenous use: US prescribing information. 2022. https://www.fda.gov/. Accessed 11 Oct 2023.

AstraZeneca AB. IMFINZI (durvalumab): EU summary of product characteristics. 2023. https://www.ema.europa.eu/. Accessed 11 Oct 2023.

AstraZeneca Co. Ltd. Imfinzi® intravenous infusion 120mg / Imfinzi® intravenous Infusion 500mg: Japanese prescribing information. 2022. https://www.pmda.go.jp/. Accessed 11 Oct 2023.

Powles T, O’Donnell PH, Massard C, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 open-label study. JAMA Oncol. 2017;3(9): e172411.

Article  PubMed  PubMed Central  Google Scholar 

Oh DY, Lee KH, Lee DW, et al. Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study. Lancet Gastroenterol Hepatol. 2022;7(6):522–32.

Article  PubMed  Google Scholar 

Lutzky J, Antonia SJ, Blake-Haskins A, et al. A phase 1 study of MEDI4736, an anti–PD-L1 antibody, in patients with advanced solid tumors [abstract no. 3001]. J Clin Oncol. 2014;32(Suppl. 15):3001.

Baverel PG, Dubois VFS, Jin CY, et al. Population pharmacokinetics of durvalumab in cancer patients and association with longitudinal biomarkers of disease status. Clin Pharmacol Ther. 2018;103(4):631–42.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Oh D-Y, Ruth He A, Qin S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. 2022;1(8):1–11.

Article  Google Scholar 

Valle JW, Qin S, Antonuzzo L, et al. Impact of mutation status on efficacy outcomes in TOPAZ-1: a phase III study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+GC) in advanced biliary tract cancer (BTC) [abstract no. 68O plus presentation]. Ann Oncol. 2022;33(Suppl. 9):S1457.

Oh DY, He AR, Qin S, et al. Updated overall survival (OS) from the phase III TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+GC) in patients (pts) with advanced biliary tract cancer (BTC) [abstract no. 56P plus poster]. Ann Oncol. 2022;33(Suppl. 7):S565–S6.

Burris HA, III, Okusaka T, Vogel A, et al. Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer [abstract no. 4070 plus poster]. J Clin Oncol. 2022;40(Suppl. 16):4070.

Rimini M, Fornaro L, Lonardi S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: an early exploratory analysis of real-world data. Liver Int. 2023;43(8):1803–12.

Article  CAS  PubMed  Google Scholar 

Paz-Ares L, Dvorkin M, Chen Y, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019;394(10212):1929–39.

Article  CAS  PubMed  Google Scholar 

Antonuzzo L, Takahashi H, Park JO, et al. Immune-mediated adverse event (imAE) incidence, timing and association with efficacy in the phase III TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+GC) in advanced biliary tract cancer (BTC) [abstract no. 57P plus poster]. Ann Oncol. 2022;33(Suppl. 7):S566-S7.

National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: biliary tract cancers (v2.2023). 2023. www.nccn.org/. Accessed 11 Oct 2023.