{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T16:54:58Z","timestamp":1792083298172,"version":"4.4.0"},"reference-count":50,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T00:00:00Z","timestamp":1751500800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Cisplatin, gemcitabine, and durvalumab combination is a standard first-line treatment for advanced biliary tract cancer. This study aimed to assess the impact of genetic alterations on outcomes in patients with advanced biliary tract cancer treated with cisplatin, gemcitabine, and durvalumab in real-world clinical practice.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients with unresectable, locally advanced, or metastatic biliary tract cancer treated with cisplatin and gemcitabine plus durvalumab across 39 centers in 11 countries in Europe, the United States, and Asia were included in this analysis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The cohort included 513 patients with advanced biliary tract cancer. The 5 most frequently altered genes were TP53 (22.1%), KRAS (13.7%), CDKN2A\/B (13.6%), ARID1A (12.2%), and IDH1 (9.2%). In multivariate analysis, SMAD4 mutations were associated with improved progression-free survival (PFS) (hazard ratio [HR]\u2009=\u20090.49, P\u2009=\u2009.018) and overall survival (HR\u2009=\u20090.11, P\u2009=\u2009.023), while TP53 mutations were linked to worse PFS (HR\u2009=\u20091.62, P\u2009=\u2009.0047) and TERT mutations to worse overall survival (HR\u2009=\u20098.92, P\u2009=\u2009.0012). No other genomic alterations were statistically associated with outcomes. Subgroup analysis showed that TP53 mutations negatively affected PFS and overall survival in intrahepatic cholangiocarcinoma, while KRAS mutations were associated with poorer PFS in extrahepatic cholangiocarcinoma. No gene alterations were linked to outcomes in gallbladder cancer.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This large-scale analysis, with comprehensive molecular profiling, supports the positive prognostic impact of SMAD4 mutations for PFS and overall survival and highlights the negative prognostic roles of TP53 (PFS) and TERT (overall survival) mutations, providing valuable insights for personalized treatment strategies in biliary tract cancer.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jnci\/djaf155","type":"journal-article","created":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T14:22:01Z","timestamp":1751552521000},"page":"2029-2043","source":"Crossref","is-referenced-by-count":6,"title":["The impact of molecular alterations in patients with advanced biliary tract cancer receiving cisplatin, gemcitabine, and durvalumab: a large, real-life, worldwide population"],"prefix":"10.1093","volume":"117","author":[{"given":"Margherita","family":"Rimini","sequence":"first","affiliation":[{"name":"Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital , Milan,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo","family":"Fornaro","sequence":"additional","affiliation":[{"name":"Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana , Pisa,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0408-5721","authenticated-orcid":false,"given":"Federica","family":"Lo Prinzi","sequence":"additional","affiliation":[{"name":"Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico , Roma 200-00128,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8322-2842","authenticated-orcid":false,"given":"Mario Domenico","family":"Rizzato","sequence":"additional","affiliation":[{"name":"Department of Oncology, Veneto Institute of Oncology IOV\u2014IRCCS , Padua,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4857-4276","authenticated-orcid":false,"given":"Anna","family":"Saborowski","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School , Hannover,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3349-5604","authenticated-orcid":false,"given":"Lorenzo","family":"Antonuzzo","sequence":"additional","affiliation":[{"name":"Clinical Oncology Unit, Careggi University Hospital , and , Florence,","place":["Italy"]},{"name":"Department of Experimental and Clinical Medicine, University of Florence , and , Florence,","place":["Italy"]},{"name":"Department of Experimental and Clinical Medicine, University of Florence , Florence,","place":["Italy"]},{"name":"Thoracic Surgery Unit, Careggi University Hospital , Florence,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4493-6380","authenticated-orcid":false,"given":"Federico","family":"Rossari","sequence":"additional","affiliation":[{"name":"Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital , Milan,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoyuki","family":"Satake","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East , 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