{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T06:02:03Z","timestamp":1784354523837,"version":"3.55.0"},"reference-count":36,"publisher":"Siapec Servizi Srl","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pathologica"],"DOI":"10.32074\/1591-951x-1317","type":"journal-article","created":{"date-parts":[[2025,12,27]],"date-time":"2025-12-27T11:47:36Z","timestamp":1766836056000},"page":"496-507","source":"Crossref","is-referenced-by-count":1,"title":["Harmonization trial of FGFR1-3 testing strategies in cholangiocarcinoma patients: an Italian multicenter experience"],"prefix":"10.32074","volume":"117","author":[{"given":"Francesco","family":"Pepe","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianluca","family":"Russo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Scimone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucia","family":"Palumbo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Tommasi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosamaria","family":"Pinto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dario","family":"De Biase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thais","family":"Maloberti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adele","family":"Busico","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Santoro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico","family":"Salemi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Melucci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico","family":"Cozzolino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luisa","family":"Toffolatti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Bessi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Sarracino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilaria","family":"Tomaiuolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelo","family":"Minucci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppina","family":"Roscigno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Esposito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierlorenzo","family":"Pallante","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Lonardi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giancarlo","family":"Pruneri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giancarlo","family":"Troncone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo","family":"Fassan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Umberto","family":"Malapelle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"21774","published-online":{"date-parts":[[2025,12]]},"reference":[{"key":"10.32074\/1591-951X-1317_ref1","doi-asserted-by":"crossref","unstructured":"Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17:557-588. https:\/\/doi.org\/10.1038\/s41575-020-0310-z","DOI":"10.1038\/s41575-020-0310-z"},{"key":"10.32074\/1591-951X-1317_ref2","doi-asserted-by":"crossref","unstructured":"Sarcognato S, Sacchi D, Fassan M, et al. Cholangiocarcinoma. Pathologica. 2021;113:158-169. https:\/\/doi.org\/10.32074\/1591-951X-252","DOI":"10.32074\/1591-951X-252"},{"key":"10.32074\/1591-951X-1317_ref3","doi-asserted-by":"crossref","unstructured":"Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362(14):1273-1281. https:\/\/doi.org\/10.1056\/NEJMoa0908721","DOI":"10.1056\/NEJMoa0908721"},{"key":"10.32074\/1591-951X-1317_ref4","doi-asserted-by":"crossref","unstructured":"Stenzinger A, Vogel A, Lehmann U, et al. Molecular profiling in cholangiocarcinoma: A practical guide to next-generation sequencing. Cancer Treat Rev. 2024;122:102649. https:\/\/doi.org\/10.1016\/j.ctrv.2023.102649","DOI":"10.1016\/j.ctrv.2023.102649"},{"key":"10.32074\/1591-951X-1317_ref5","doi-asserted-by":"crossref","unstructured":"Simbolo M, Fassan M, Ruzzenente A, et al. Multigene mutational profiling of cholangiocarcinomas identifies actionable molecular subgroups. Oncotarget. 2014;5(9):2839-2852. https:\/\/doi.org\/10.18632\/oncotarget.1943","DOI":"10.18632\/oncotarget.1943"},{"key":"10.32074\/1591-951X-1317_ref6","doi-asserted-by":"crossref","unstructured":"Vogel A, Ducreux M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline interim update on the management of biliary tract cancer. ESMO Open. 2025;10(1):104003. https:\/\/doi.org\/10.1016\/j.esmoop.2024.104003","DOI":"10.1016\/j.esmoop.2024.104003"},{"key":"10.32074\/1591-951X-1317_ref7","doi-asserted-by":"crossref","unstructured":"Spencer K, Pappas L, Baiev I, et al. Molecular profiling and treatment pattern differences between intrahepatic and extrahepatic cholangiocarcinoma. J Natl Cancer Inst. 2023;115(7):870-880. https:\/\/doi.org\/10.1093\/jnci\/djad046","DOI":"10.1093\/jnci\/djad046"},{"key":"10.32074\/1591-951X-1317_ref8","doi-asserted-by":"crossref","unstructured":"Silverman IM, Hollebecque A, Friboulet L, et al. Clinicogenomic Analysis of FGFR2-Rearranged Cholangiocarcinoma Identifies Correlates of Response and Mechanisms of Resistance to Pemigatinib. Cancer Discov. 2021;11(2):326-339. https:\/\/doi.org\/10.1158\/2159-8290.CD-20-0766","DOI":"10.1158\/2159-8290.CD-20-0766"},{"key":"10.32074\/1591-951X-1317_ref9","doi-asserted-by":"crossref","unstructured":"Graham RP, Barr Fritcher EG, Pestova E, et al. Fibroblast growth factor receptor 2 translocations in intrahepatic cholangiocarcinoma. Hum Pathol. 2014;45(8):1630-1638. https:\/\/doi.org\/10.1016\/j.humpath.2014.03.014","DOI":"10.1016\/j.humpath.2014.03.014"},{"key":"10.32074\/1591-951X-1317_ref10","doi-asserted-by":"crossref","unstructured":"Ross JS, Wang K, Gay L, et al. New routes to targeted therapy of intrahepatic cholangiocarcinomas revealed by next-generation sequencing. Oncologist. 2014;19(3):235-242. https:\/\/doi.org\/10.1634\/theoncologist.2013-0352","DOI":"10.1634\/theoncologist.2013-0352"},{"key":"10.32074\/1591-951X-1317_ref11","doi-asserted-by":"crossref","unstructured":"Goyal L, Kongpetch S, Crolley VE, Bridgewater J. Targeting FGFR inhibition in cholangiocarcinoma. Cancer Treat Rev. 2021;95:102170. https:\/\/doi.org\/10.1016\/j.ctrv.2021.102170","DOI":"10.1016\/j.ctrv.2021.102170"},{"key":"10.32074\/1591-951X-1317_ref12","doi-asserted-by":"crossref","unstructured":"Sasaki M, Sato Y, Nakanuma Y. Expression of fibroblast growth factor receptor 2 (FGFR2) in combined hepatocellular-cholangiocarcinoma and intrahepatic cholangiocarcinoma: clinicopathological study. Virchows Arch. 2024;484(6):915-923. https:\/\/doi.org\/10.1007\/s00428-024-03792-x","DOI":"10.1007\/s00428-024-03792-x"},{"key":"10.32074\/1591-951X-1317_ref13","doi-asserted-by":"crossref","unstructured":"Vogel A, Sahai V, Hollebecque A, et al. An open-label study of pemigatinib in cholangiocarcinoma: final results from FIGHT-202. ESMO Open. 2024;9(6):103488. https:\/\/doi.org\/10.1016\/j.esmoop.2024.103488","DOI":"10.1016\/j.esmoop.2024.103488"},{"key":"10.32074\/1591-951X-1317_ref14","doi-asserted-by":"crossref","unstructured":"Angerilli V, Fornaro L, Pepe F, et al. FGFR2 testing in cholangiocarcinoma: translating molecular studies into clinical practice. Pathologica. 2023;115(2):71-82. https:\/\/doi.org\/10.32074\/1591-951X-859","DOI":"10.32074\/1591-951X-859"},{"key":"10.32074\/1591-951X-1317_ref15","doi-asserted-by":"crossref","unstructured":"Parisi A, Delaunay B, Pinterpe G, et al. Pemigatinib for patients with previously treated, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements: A joint analysis of the French PEMI-BIL and Italian PEMI-REAL cohort studies. Eur J Cancer. 2024;200:113587. https:\/\/doi.org\/10.1016\/j.ejca.2024.113587","DOI":"10.1016\/j.ejca.2024.113587"},{"key":"10.32074\/1591-951X-1317_ref16","doi-asserted-by":"crossref","unstructured":"DeHaan RD, Kipp BR, Smyrk TC, et al. An assessment of chromosomal alterations detected by fluorescence in situ hybridization and p16 expression in sporadic and primary sclerosing cholangitis-associated cholangiocarcinomas. Hum Pathol. 2007;38(3):491-499. https:\/\/doi.org\/10.1016\/j.humpath.2006.09.004","DOI":"10.1016\/j.humpath.2006.09.004"},{"key":"10.32074\/1591-951X-1317_ref17","doi-asserted-by":"crossref","unstructured":"Neumann O, Lehmann U, Bartels S, et al. First proficiency testing for NGS-based and combined NGS- and FISH-based detection of FGFR2 fusions in intrahepatic cholangiocarcinoma. J Pathol Clin Res. 2023;9(2):100-107. https:\/\/doi.org\/10.1002\/cjp2.308","DOI":"10.1002\/cjp2.308"},{"key":"10.32074\/1591-951X-1317_ref18","doi-asserted-by":"crossref","unstructured":"Pepe F, Russo G, Venuta A, et al. Non-Small Cell Lung Cancer Testing on Reference Specimens: An Italian Multicenter Experience. Oncol Ther. 2024;12(1):73-95. https:\/\/doi.org\/10.1007\/s40487-023-00252-5.","DOI":"10.1007\/s40487-023-00252-5"},{"key":"10.32074\/1591-951X-1317_ref19","doi-asserted-by":"crossref","unstructured":"De Luca C, Pepe F, Russo G, et al. Technical Validation of a Fully Integrated NGS Platform in the Real-World Practice of Italian Referral Institutions. Journal of Molecular Pathology. 2023; 4(4):259-274. https:\/\/doi.org\/10.3390\/jmp4040022","DOI":"10.3390\/jmp4040022"},{"key":"10.32074\/1591-951X-1317_ref20","doi-asserted-by":"crossref","unstructured":"Nero C, Duranti S, Giacomini F, et al. Integrating a Comprehensive Cancer Genome Profiling into Clinical Practice: A Blueprint in an Italian Referral Center. J Pers Med. 2022;12(10):1746. Published 2022 Oct 20. https:\/\/doi.org\/10.3390\/jpm12101746","DOI":"10.3390\/jpm12101746"},{"key":"10.32074\/1591-951X-1317_ref21","doi-asserted-by":"crossref","unstructured":"Giac\u00f2 L, Palluzzi F, Guido D, et al. A Computational Framework for Comprehensive Genomic Profiling in Solid Cancers: The Analytical Performance of a High-Throughput Assay for Small and Copy Number Variants. Cancers (Basel). 2022;14(24):6152. Published 2022 Dec 13. https:\/\/doi.org\/10.3390\/cancers14246152","DOI":"10.3390\/cancers14246152"},{"key":"10.32074\/1591-951X-1317_ref22","doi-asserted-by":"crossref","unstructured":"Pisapia P, L\u2019Imperio V, Galuppini F, et al. The evolving landscape of anatomic pathology. Crit Rev Oncol Hematol. 2022;178:103776. https:\/\/doi.org\/10.1016\/j.critrevonc.2022.103776","DOI":"10.1016\/j.critrevonc.2022.103776"},{"key":"10.32074\/1591-951X-1317_ref23","doi-asserted-by":"crossref","unstructured":"Bekaii-Saab TS, Valle JW, Van Cutsem E, et al. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020;16(30):2385-2399. https:\/\/doi.org\/10.2217\/fon-2020-0429","DOI":"10.2217\/fon-2020-0429"},{"key":"10.32074\/1591-951X-1317_ref24","doi-asserted-by":"crossref","unstructured":"Maruki Y, Morizane C, Arai Y, et al. Molecular detection and clinicopathological characteristics of advanced\/recurrent biliary tract carcinomas harboring the FGFR2 rearrangements: a prospective observational study (PRELUDE Study). J Gastroenterol. 2021;56(3):250-260. https:\/\/doi.org\/10.1007\/s00535-020-01735-2","DOI":"10.1007\/s00535-020-01735-2"},{"key":"10.32074\/1591-951X-1317_ref25","doi-asserted-by":"crossref","unstructured":"Chrzanowska NM, Kowalewski J, Lewandowska MA. Use of Fluorescence In Situ Hybridization (FISH) in Diagnosis and Tailored Therapies in Solid Tumors. Molecules. 2020;25(8):1864. Published 2020 Apr 17. https:\/\/doi.org\/10.3390\/molecules25081864","DOI":"10.3390\/molecules25081864"},{"key":"10.32074\/1591-951X-1317_ref26","doi-asserted-by":"crossref","unstructured":"Mosele F, Remon J, Mateo J, et al. Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2020;31(11):1491-1505. https:\/\/doi.org\/10.1016\/j.annonc.2020.07.014","DOI":"10.1016\/j.annonc.2020.07.014"},{"key":"10.32074\/1591-951X-1317_ref27","doi-asserted-by":"crossref","unstructured":"Benson AB, D\u2019Angelica MI, Abbott DE, et al. Hepatobiliary Cancers, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021;19(5):541-565. Published 2021 May 1. https:\/\/doi.org\/10.6004\/jnccn.2021.0022","DOI":"10.6004\/jnccn.2021.0022"},{"key":"10.32074\/1591-951X-1317_ref28","doi-asserted-by":"crossref","unstructured":"Zhang X, Bai Q, Wang Y, et al. FGFR2 fusion\/rearrangement analysis in intrahepatic cholangiocarcinoma using DNA\/RNA-based NGS and FISH. Virchows Arch. Published online April 8, 2025. https:\/\/doi.org\/10.1007\/s00428-025-04067-9","DOI":"10.1007\/s00428-025-04067-9"},{"key":"10.32074\/1591-951X-1317_ref29","doi-asserted-by":"crossref","unstructured":"Katoh M. Fibroblast growth factor receptors as treatment targets in clinical oncology. Nat Rev Clin Oncol. 2019;16(2):105-122. https:\/\/doi.org\/10.1038\/s41571-018-0115-y","DOI":"10.1038\/s41571-018-0115-y"},{"key":"10.32074\/1591-951X-1317_ref30","doi-asserted-by":"crossref","unstructured":"Nibid L, Sabarese G, Righi D, et al. Feasibility of Comprehensive Genomic Profiling (CGP) in Real-Life Clinical Practice. Diagnostics (Basel). 2023;13(4):782. Published 2023 Feb 19. https:\/\/doi.org\/10.3390\/diagnostics13040782.","DOI":"10.3390\/diagnostics13040782"},{"key":"10.32074\/1591-951X-1317_ref31","doi-asserted-by":"crossref","unstructured":"Lowery MA, Ptashkin R, Jordan E, et al. Comprehensive Molecular Profiling of Intrahepatic and Extrahepatic Cholangiocarcinomas: Potential Targets for Intervention. Clin Cancer Res. 2018;24(17):4154-4161. https:\/\/doi.org\/10.1158\/1078-0432.CCR-18-0078","DOI":"10.1158\/1078-0432.CCR-18-0078"},{"key":"10.32074\/1591-951X-1317_ref32","doi-asserted-by":"crossref","unstructured":"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):127-140. https:\/\/doi.org\/10.1016\/j.annonc.2022.10.506","DOI":"10.1016\/j.annonc.2022.10.506"},{"key":"10.32074\/1591-951X-1317_ref33","doi-asserted-by":"crossref","unstructured":"Rimassa L, Khan S, Groot Koerkamp B, et al. Mapping the landscape of biliary tract cancer in Europe: challenges and controversies. Lancet Reg Health Eur. 2025;50:101171. Published 2025 Feb 19. https:\/\/doi.org\/10.1016\/j.lanepe.2024.101171","DOI":"10.1016\/j.lanepe.2024.101171"},{"key":"10.32074\/1591-951X-1317_ref34","doi-asserted-by":"crossref","unstructured":"Rimassa L, Lamarca A, O\u2019Kane GM, et al. New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe. Lancet Reg Health Eur. 2025;50:101170. Published 2025 Feb 19. https:\/\/doi.org\/10.1016\/j.lanepe.2024.101170","DOI":"10.1016\/j.lanepe.2024.101170"},{"key":"10.32074\/1591-951X-1317_ref35","doi-asserted-by":"crossref","unstructured":"Gray ER, Mordaka JM, Christoforou ER, et al. Ultra-sensitive molecular detection of gene fusions from RNA using ASPYRE. BMC Med Genomics. 2022;15(1):215. Published 2022 Oct 12. https:\/\/doi.org\/10.1186\/s12920-022-01363-0","DOI":"10.1186\/s12920-022-01363-0"},{"key":"10.32074\/1591-951X-1317_ref36","doi-asserted-by":"crossref","unstructured":"Barua S, Wang G, Mansukhani M, et al. Key considerations for comprehensive validation of an RNA fusion NGS panel. Pract Lab Med. 2020;21:e00173. Published 2020 Jun 8. https:\/\/doi.org\/10.1016\/j.plabm.2020.e00173","DOI":"10.1016\/j.plabm.2020.e00173"}],"container-title":["Pathologica"],"original-title":[],"link":[{"URL":"https:\/\/www.pathologica.it\/article\/view\/1317","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,27]],"date-time":"2025-12-27T11:47:58Z","timestamp":1766836078000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.pathologica.it\/article\/view\/1317"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12]]},"references-count":36,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025,10]]}},"URL":"https:\/\/doi.org\/10.32074\/1591-951x-1317","relation":{},"ISSN":["1591-951X"],"issn-type":[{"value":"1591-951X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12]]},"article-number":"5"}}