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• W4366000434 abstract "Biliary tract cancers have increased in incidence in many parts of the world, particularly cases of intrahepatic disease. 1 Saha SK Zhu AX Fuchs CS Brooks GA Forty-year trends in cholangiocarcinoma incidence in the U.S.: intrahepatic disease on the rise. Oncologist. 2016; 21: 594-599 Crossref PubMed Scopus (443) Google Scholar , 2 Banales JM Cardinale V Carpino G et al. Expert consensus document: cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol. 2016; 13: 261-280 Crossref PubMed Scopus (791) Google Scholar The incidence of cholangiocarcinoma varies geographically, with 1·6 cases per 100 000 people in the USA, for example, but substantially higher rates in parts of east Asia. 2 Banales JM Cardinale V Carpino G et al. Expert consensus document: cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol. 2016; 13: 261-280 Crossref PubMed Scopus (791) Google Scholar Most patients present with advanced disease not amenable to surgery and require systemic therapy. For more than 10 years, gemcitabine and cisplatin was the internationally accepted first-line treatment for patients with locally advanced and metastatic biliary tract cancer, as per the ABC-02 study. 3 Valle J Wasan H Palmer DH et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010; 362: 1273-1281 Crossref PubMed Scopus (2855) Google Scholar Despite doublet chemotherapy, outcomes are poor, with a median overall survival of between 4·6 and 11·7 months according to a systematic review of multiple studies. 4 Park JO Oh D-Y Hsu C et al. Gemcitabine plus cisplatin for advanced biliary tract cancer: a systematic review. Cancer Res Treat. 2015; 47: 343-361 Crossref PubMed Scopus (62) Google Scholar This therefore represents an area of high unmet need. In 2022, the TOPAZ-1 study showed a significant improvement in median overall survival in patients receiving durvalumab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone (hazard ratio [HR] 0·80 [95% CI 0·66–0·97]; p=0·021). 5 Do-Youn O Aiwu RH Shukui Q et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. 2022; 1EVIDoa2200015 Google Scholar This combination was subsequently approved by the US Food and Drug Administration in September, 2022, providing a new standard of care. Further progress has been made through the use of drugs targeting IDH1, 6 Abou-Alfa GK Macarulla T Javle MM et al. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020; 21: 796-807 Summary Full Text Full Text PDF PubMed Scopus (453) Google Scholar HER2, 7 Javle M Borad MJ Azad NS et al. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021; 22: 1290-1300 Summary Full Text Full Text PDF PubMed Scopus (111) Google Scholar and FGFR2, 8 Abou-Alfa GK Sahai V Hollebecque A et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020; 21: 671-684 Summary Full Text Full Text PDF PubMed Scopus (680) Google Scholar but fewer than half of patients have targetable alterations 9 Nakamura H Arai Y Totoki Y et al. Genomic spectra of biliary tract cancer. Nat Genet. 2015; 47: 1003-1010 Crossref PubMed Scopus (776) Google Scholar and these therapies are reserved for second-line use in most circumstances. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trialBased on a statistically significant, clinically meaningful improvement in overall survival compared with gemcitabine and cisplatin without any new safety signals, pembrolizumab plus gemcitabine and cisplatin could be a new treatment option for patients with previously untreated metastatic or unresectable biliary tract cancer. Full-Text PDF" @default.
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• W4366000434 date "2023-06-01" @default.
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• W4366000434 title "Pembrolizumab plus chemotherapy as first-line treatment for advanced biliary tract cancer" @default.
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