{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:30:54Z","timestamp":1787009454640,"version":"build-2736575974"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,10,20]],"date-time":"2024-10-20T00:00:00Z","timestamp":1729382400000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,3,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In the TOPAZ-1, patients with biliary tract cancers (BTC) and recurrence within 6 months after surgery were excluded, even if this event is frequently observed in clinical practice. Our study aimed to assess if the efficacy of cisplatin-gemcitabine-durvalumab (CGD) in this population is comparable to that reported in the phase 3 trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study cohort included patients with BTC who underwent surgery on the primary tumor, experienced disease recurrence occurring \u22646 months or &amp;gt;6 months after surgery or after the end of adjuvant therapy and started CGD. The primary objectives were overall survival (OS) and progression free survival (PFS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 178 patients were enrolled. No significant differences were observed between early and late relapse groups in OS (23.4 months vs not reached; HR 1.26; 95% CI, 0.67-2.37; P\u2005=\u2005.45) and PFS [7.0 months vs 9.8 months; HR 1.3(95% CI, 0.9-2.1) P\u2005=\u2005.13]. Overall response rate and disease control rate (P\u2005=\u2005.33 and P\u2005=\u2005.62) were comparable between the 2 groups, as the overall safety profile. In addition, we compared survival outcomes between the selected population and a historical cohort of patients with BTC treated with cisplatin-gemcitabine (CG) and found that despite the absence of statistical significance, CGD showed an outcome trend compared with CG regardless of the time of recurrence after surgery or adjuvant chemotherapy [(CG\u2005\u2264\u20056 vs CGD\u2005\u2264\u20056 months: HR 0.59, 95%CI, 0.35-1.01, P\u2005=\u2005.05; HR 0.70; 95%CI, 0.46-1.06, P\u2005=\u2005.09, OS and PFS, respectively) and (CG\u2005&amp;gt;\u20056 vs. CGD\u2005&amp;gt;\u20056 months: HR 0.50; 95%CI, 0.29-0.88, P\u2005=\u20050.0165; HR 0.54; 95%CI, 0.35-0.84, P\u2005=\u2005.0068, OS and PFS, respectively)].<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Our analysis suggests that CGD retains its efficacy independently of the timing of relapse after surgery or completion of adjuvant treatment in patients with advanced BTC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/oncolo\/oyae256","type":"journal-article","created":{"date-parts":[[2024,9,6]],"date-time":"2024-09-06T17:58:29Z","timestamp":1725645509000},"source":"Crossref","is-referenced-by-count":10,"title":["Efficacy of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population"],"prefix":"10.1093","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0408-5721","authenticated-orcid":false,"given":"Federica","family":"Lo Prinzi","sequence":"first","affiliation":[{"name":"Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico , Via Alvaro del Portillo, 200 - 00128 Roma ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Salani","sequence":"additional","affiliation":[{"name":"Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana , 56126 Pisa ,","place":["Italy"]},{"name":"Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa , 56126 Pisa ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margherita","family":"Rimini","sequence":"additional","affiliation":[{"name":"Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital , 20132 Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario Domenico","family":"Rizzato","sequence":"additional","affiliation":[{"name":"Department of Oncology, Veneto Institute of Oncology IOV - IRCCS , 35128 Padua ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo","family":"Antonuzzo","sequence":"additional","affiliation":[{"name":"Clinical Oncology Unit, Department of Experimental and Clinical Medicine, Careggi University Hospital, University of Florence , 50134 Florence ,","place":["Italy"]},{"name":"Thoracic Surgery Unit, Department of Experimental and Clinical Medicine, Careggi University Hospital, University of Florence , 50134 Florence ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Camera","sequence":"additional","affiliation":[{"name":"Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital , 20132 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 , Kashiwa 277-8577 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanne","family":"Vandeputte","sequence":"additional","affiliation":[{"name":"Digestive Oncology, University Hospitals Leuven , 3000 Leuven ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caterina","family":"Vivaldi","sequence":"additional","affiliation":[{"name":"Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana , 56126 Pisa ,","place":["Italy"]},{"name":"Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa , 56126 Pisa ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiziana","family":"Pressiani","sequence":"additional","affiliation":[{"name":"Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital , Rozzano, 20089 Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Lucchetti","sequence":"additional","affiliation":[{"name":"Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico , Via Alvaro del Portillo, 200 - 00128 Roma ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin Won","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine , Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620 ,","place":["Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oluseyi","family":"Abidoye","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Mayo Clinic , Phoenix, AZ 5777 ,","place":["United 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Scotland Centre ,\u00a0 Glasgow\u00a0G61 1BD ,\u00a0","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Pastorino","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale Policlinico San Martino, Medical Oncology Unit 1 , 16132 Genova ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Castet","sequence":"additional","affiliation":[{"name":"Gastrointestinal and Endocrine Tumor Unit, Vall d\u2019Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d\u2019Hebron, Vall d\u2019Hebron Barcelona Hospital Campus , 08035 Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emiliano","family":"Tamburini","sequence":"additional","affiliation":[{"name":"Department of Oncology and Palliative Care, Cardinale G Panico, Tricase City Hospital , 73039 Tricase 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,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianluca","family":"Masi","sequence":"additional","affiliation":[{"name":"Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana , 56126 Pisa ,","place":["Italy"]},{"name":"Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa , 56126 Pisa ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Lonardi","sequence":"additional","affiliation":[{"name":"Department of Oncology, Veneto Institute of Oncology IOV - IRCCS , 35128 Padua ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenza","family":"Rimassa","sequence":"additional","affiliation":[{"name":"Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital , Rozzano, 20089 Milan ,","place":["Italy"]},{"name":"Department of Biomedical Sciences, Humanitas University , 20072 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