{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T23:56:03Z","timestamp":1790207763460,"version":"4.1.0"},"reference-count":37,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Ministero della Salute (Ricerca Corrente), Rome, Italy"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Cholangiocarcinoma (CCA) is a cancer with a low survival rate. New drugs targeting molecular alterations, oncogenic mutations, and gene fusions are being tested as second-line treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>This systematic review aims to summarize the results obtained with three new targeted therapies\u2014pemigatinib, futibatinib, and ivosidenib\u2014for the treatment of CCA, evaluating their safety and tolerability profiles in patients, compared to current standard therapies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data sources and methods:<\/jats:title>\n                    <jats:p>A systematic literature search was performed with a cutoff date of July 24, 2023, in MEDLINE, Embase, and the Cochrane Library. The authors also conducted an advanced search in the ClinicalTrials.gov database, evaluated conference abstracts, article bibliographies, and drug monographs. Studies involving the treatment of patients with pemigatinib, futibatinib, and ivosidenib were considered. The selected studies had to report adverse events (AEs) that occurred during treatment with these therapies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The most common AEs observed with pemigatinib, futibatinib, and ivosidenib were alopecia, diarrhea, fatigue, and dysgeusia. In addition, hyperphosphatemia, hypophosphatemia, and ocular disorders were observed with fibroblast growth factor receptor (FGFR) inhibitors, while the isocitrate dehydrogenase 1 (IDH1) inhibitor was associated with dose-dependent prolongation of the corrected QT interval (QTc). These AEs were effectively managed through dose adjustments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>FGFR2 and IDH1 inhibitors have good tolerability in the population examined. All AEs were optimally managed with dose modulation. Future studies should focus on identifying the most effective dosages to further enhance treatment safety.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20420986251347376","type":"journal-article","created":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T10:10:41Z","timestamp":1755598241000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Safety profiles of the new target therapies\u2014pemigatinib, futibatinib, and ivosidenib\u2014for the treatment of cholangiocarcinoma: a systematic review"],"prefix":"10.1177","volume":"16","author":[{"given":"Giulia","family":"Matranga","sequence":"first","affiliation":[{"name":"Master in Pharmacovigilance, Pharmacoepidemiology, Pharmacoeconomics, and Real-World Evidence, University of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1931-8330","authenticated-orcid":false,"given":"Anna","family":"Carollo","sequence":"additional","affiliation":[{"name":"Clinical Pharmacy Service, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS ISMETT), Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"Alaimo","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center, University of Messina, Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sofia","family":"Cutaia","sequence":"additional","affiliation":[{"name":"Medical Oncology Service, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS ISMETT), Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Rizzo","sequence":"additional","affiliation":[{"name":"Medical Oncology Service, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS ISMETT), Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7132-000X","authenticated-orcid":false,"given":"Alessio","family":"Provenzani","sequence":"additional","affiliation":[{"name":"Clinical Pharmacy Service, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS ISMETT), Via E.Tricomi n. 5, Palermo 90127, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,8,19]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrgastro.2016.51"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/liv.14095"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.5582\/irdr.2022.01109"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.3390\/cells9030688"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-017-14838-3"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2019.03.013"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdt540"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0908721"},{"key":"e_1_3_4_10_2","article-title":"78P 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)","volume":"33","author":"Oh D-Y","year":"2022","unstructured":"Oh D-Y, He AR, Qin S, et al. 78P 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). Ann Oncol 2022; 33: S1462\u2013S1463.","journal-title":"Ann Oncol"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2019.37.15_suppl.4003"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2022.11.030"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.critrevonc.2023.104146"},{"key":"e_1_3_4_14_2","unstructured":"PEMAZYRE (pemigatinib) [Internet]. [Cited 23 March 2025] https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/213736s002lbl.pdf (2022 accessed 24 July 2023)."},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-22-2036"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01330-y"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2023.2227561"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-19-2568"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1002\/cmdc.201800719"},{"key":"e_1_3_4_20_2","unstructured":"LYTGOBI (futibatinib) [Internet]. [Cited 23 March 2025] https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/214801s000lbl.pdf (2022 accessed 24 July 2023)."},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2020.06.018"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13585"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.21037\/jgo.2019.03.10"},{"key":"e_1_3_4_24_2","unstructured":"U.S. Food and Drug Administration. TIBSOVO\u00ae (ivosidenib tablets) for oral use. Initial U.S. approval. Silver Spring MD: U.S. Food and Drug Administration 2018."},{"key":"e_1_3_4_25_2","article-title":"The PRISMA 2020 statement: an updated guideline for reporting systematic reviews","volume":"372","author":"Page MJ","year":"2021","unstructured":"Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372: n71.","journal-title":"BMJ"},{"key":"e_1_3_4_26_2","article-title":"RoB 2: a revised tool for assessing risk of bias in randomised trials","volume":"366","author":"Sterne JAC","year":"2019","unstructured":"Sterne JAC, Savovi\u0107 J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019; 366: l4898.","journal-title":"BMJ"},{"key":"e_1_3_4_27_2","article-title":"ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions","volume":"355","author":"Sterne JA","year":"2016","unstructured":"Sterne JA, Hern\u00e1n MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ 2016; 355: i4919.","journal-title":"BMJ"},{"key":"e_1_3_4_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(20)30109-1"},{"key":"e_1_3_4_29_2","doi-asserted-by":"publisher","DOI":"10.1002\/cam4.5273"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2206834"},{"key":"e_1_3_4_31_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2021.3836"},{"key":"e_1_3_4_32_2","unstructured":"Common Terminology Criteria for Adverse Events (CTCAE)-Version 4.03 [Internet] https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/CTCAE_4.03\/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf (2010 accessed 24 July 2023)."},{"key":"e_1_3_4_33_2","unstructured":"Common Terminology Criteria for Adverse Events (CTCAE)-Version 5.0 [Internet] https:\/\/ctep.cancer.gov\/protocoldevelopment\/electronic_applications\/docs\/ctcae_v5_quick_reference_5x7.pdf (2017 accessed 24 July 2023)."},{"key":"e_1_3_4_34_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.10.013"},{"key":"e_1_3_4_35_2","doi-asserted-by":"publisher","DOI":"10.5009\/gnl15568"},{"key":"e_1_3_4_36_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.32771"},{"key":"e_1_3_4_37_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrclinonc.2011.156"},{"key":"e_1_3_4_38_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2013.10.016"}],"container-title":["Therapeutic Advances in Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20420986251347376","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/20420986251347376","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20420986251347376","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:40:59Z","timestamp":1777592459000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/20420986251347376"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8]]},"references-count":37,"alternative-id":["10.1177\/20420986251347376"],"URL":"https:\/\/doi.org\/10.1177\/20420986251347376","relation":{},"ISSN":["2042-0986","2042-0994"],"issn-type":[{"value":"2042-0986","type":"print"},{"value":"2042-0994","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8]]},"article-number":"20420986251347376"}}