{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,8]],"date-time":"2025-11-08T12:17:03Z","timestamp":1762604223082},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,6,18]],"date-time":"2020-06-18T00:00:00Z","timestamp":1592438400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,6,18]],"date-time":"2020-06-18T00:00:00Z","timestamp":1592438400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cancer Chemother Pharmacol"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>Therapeutic options are limited for advanced, metastatic biliary tract cancer. The pivotal NAPOLI-1 trial demonstrated the superior clinical benefit of nanoliposomal irinotecan (Nal-IRI) in gemcitabine-pretreated patients with metastatic pancreatic ductal adenocarcinoma; however, the antitumor activity of Nal-IRI in biliary tract cancer is unknown. This is the first report describing the efficacy of Nal-IRI in biliary tract cancer.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>In this multicenter retrospective cohort analysis, we identified patients with metastatic biliary tract adenocarcinoma who were treated with Nal-IRI in combination with 5-fluorouracil and folinic acid following tumor progression under standard therapy at one of the study centers between May 2016 and January 2019. We assessed disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>There were 14 patients; the median age at the time of diagnosis and the median age at the initiation of Nal-IRI were 59.3 and 60.0\u00a0years, respectively. Nal-IRI in combination with 5-fluorouracil and folinic acid was administered as second-, third-, fourth-, and fifth-line treatment in 6 (43%), 5 (36%), 2 (14%), and 1 (7%) patient with metastatic disease, respectively. The objective DCR with Nal-IRI was 50% (7\/14 patients). Six patients (43%) had partial response, and one patient (7%) had stable disease. Progressive disease was observed in seven patients. The median PFS and median OS following Nal-IRI initiation were 10.6 and 24.1\u00a0months, respectively.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>This retrospective analysis provides the first evidence that Nal-IRI might exhibit a clinical meaningful antitumor activity in metastatic biliary tract cancer.<\/jats:p>\n<\/jats:sec>","DOI":"10.1007\/s00280-020-04094-0","type":"journal-article","created":{"date-parts":[[2020,6,18]],"date-time":"2020-06-18T13:02:27Z","timestamp":1592485347000},"page":"109-115","update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["First evidence for the antitumor activity of nanoliposomal irinotecan with 5-fluorouracil and folinic acid in metastatic biliary tract cancer"],"prefix":"10.1007","volume":"86","author":[{"given":"Hossein","family":"Taghizadeh","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthias","family":"Unseld","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Schmiderer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Djanani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"Wilthoner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dieter","family":"Buchinger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerald W.","family":"Prager","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,6,18]]},"reference":[{"issue":"2","key":"4094_CR1","doi-asserted-by":"publisher","first-page":"104","DOI":"10.1080\/13651820701216216","volume":"9","author":"J Bridgewater","year":"2007","unstructured":"Bridgewater J, Imber C (2007) New advances in the management of biliary tract cancer. HPB (Oxford) 9(2):104\u2013111","journal-title":"HPB (Oxford)"},{"issue":"1","key":"4094_CR2","first-page":"28","volume":"11","author":"KK Ciombor","year":"2013","unstructured":"Ciombor KK, Goff LW (2013) Advances in the management of biliary tract cancers. Clin Adv Hematol Oncol 11(1):28\u201334","journal-title":"Clin Adv Hematol Oncol"},{"key":"4094_CR3","doi-asserted-by":"publisher","first-page":"e194","DOI":"10.14694\/EDBK_160831","volume":"35","author":"JA Bridgewater","year":"2016","unstructured":"Bridgewater JA et al (2016) Biliary tract cancer: epidemiology, radiotherapy, and molecular profiling. Am Soc Clin Oncol Educ Book 35:e194\u2013203","journal-title":"Am Soc Clin Oncol Educ Book"},{"issue":"3","key":"4094_CR4","doi-asserted-by":"publisher","first-page":"430","DOI":"10.21037\/jgo.2017.05.04","volume":"8","author":"DY Zhao","year":"2017","unstructured":"Zhao DY, Lim KH (2017) Current biologics for treatment of biliary tract cancers. J Gastrointest Oncol 8(3):430\u2013440","journal-title":"J Gastrointest Oncol"},{"issue":"14","key":"4094_CR5","doi-asserted-by":"publisher","first-page":"1273","DOI":"10.1056\/NEJMoa0908721","volume":"362","author":"J Valle","year":"2010","unstructured":"Valle J et al (2010) Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362(14):1273\u20131281","journal-title":"N Engl J Med"},{"issue":"15_suppl","key":"4094_CR6","doi-asserted-by":"publisher","first-page":"4003","DOI":"10.1200\/JCO.2019.37.15_suppl.4003","volume":"37","author":"A Lamarca","year":"2019","unstructured":"Lamarca A et al (2019) ABC-06|A randomised phase III, multi-centre, open-label study of active symptom control (ASC) alone or ASC with oxaliplatin\/5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced\/metastatic biliary tract cancers (ABC) previously-treated with cisplatin\/gemcitabine (CisGem) chemotherapy. J Clin Oncol 37(15_suppl):4003\u20134003","journal-title":"J Clin Oncol"},{"issue":"12","key":"4094_CR7","doi-asserted-by":"publisher","first-page":"2328","DOI":"10.1093\/annonc\/mdu162","volume":"25","author":"A Lamarca","year":"2014","unstructured":"Lamarca A et al (2014) Second-line chemotherapy in advanced biliary cancer: a systematic review. Ann Oncol 25(12):2328\u20132338","journal-title":"Ann Oncol"},{"issue":"4","key":"4094_CR8","doi-asserted-by":"publisher","first-page":"189","DOI":"10.1038\/nrgastro.2011.20","volume":"8","author":"T Patel","year":"2011","unstructured":"Patel T (2011) Cholangiocarcinoma\u2013controversies and challenges. Nat Rev Gastroenterol Hepatol 8(4):189\u2013200","journal-title":"Nat Rev Gastroenterol Hepatol"},{"issue":"2","key":"4094_CR9","doi-asserted-by":"publisher","first-page":"324","DOI":"10.21037\/jgo.2016.09.16","volume":"8","author":"S Sahu","year":"2017","unstructured":"Sahu S, Sun W (2017) Targeted therapy in biliary tract cancers-current limitations and potentials in the future. J Gastrointest Oncol 8(2):324\u2013336","journal-title":"J Gastrointest Oncol"},{"issue":"1","key":"4094_CR10","first-page":"42","volume":"31","author":"MC Bragazzi","year":"2018","unstructured":"Bragazzi MC et al (2018) New insights into cholangiocarcinoma: multiple stems and related cell lineages of origin. Ann Gastroenterol 31(1):42\u201355","journal-title":"Ann Gastroenterol"},{"issue":"17","key":"4094_CR11","doi-asserted-by":"publisher","first-page":"14744","DOI":"10.18632\/oncotarget.4539","volume":"6","author":"G Brandi","year":"2015","unstructured":"Brandi G et al (2015) Genetic heterogeneity in cholangiocarcinoma: a major challenge for targeted therapies. Oncotarget 6(17):14744\u201314753","journal-title":"Oncotarget"},{"key":"4094_CR12","doi-asserted-by":"publisher","first-page":"3001","DOI":"10.2147\/OTT.S105587","volume":"9","author":"H Zhang","year":"2016","unstructured":"Zhang H (2016) Onivyde for the therapy of multiple solid tumors. Onco Targets Ther 9:3001\u20133007","journal-title":"Onco Targets Ther"},{"issue":"3","key":"4094_CR13","doi-asserted-by":"publisher","first-page":"579","DOI":"10.1007\/s00280-014-2671-x","volume":"75","author":"TC Chang","year":"2015","unstructured":"Chang TC et al (2015) Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients. Cancer Chemother Pharmacol 75(3):579\u2013586","journal-title":"Cancer Chemother Pharmacol"},{"key":"4094_CR14","doi-asserted-by":"publisher","first-page":"1455","DOI":"10.2147\/OTT.S167590","volume":"12","author":"W Woo","year":"2019","unstructured":"Woo W, Carey ET, Choi M (2019) Spotlight on liposomal irinotecan for metastatic pancreatic cancer: patient selection and perspectives. Onco Targets Ther 12:1455\u20131463","journal-title":"Onco Targets Ther"},{"key":"4094_CR15","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1016\/j.ejca.2018.12.007","volume":"108","author":"A Wang-Gillam","year":"2019","unstructured":"Wang-Gillam A et al (2019) NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: final overall survival analysis and characteristics of long-term survivors. Eur J Cancer 108:78\u201387","journal-title":"Eur J Cancer"},{"issue":"1","key":"4094_CR16","doi-asserted-by":"publisher","first-page":"88","DOI":"10.1002\/cam4.566","volume":"5","author":"RB Schmuck","year":"2016","unstructured":"Schmuck RB et al (2016) Distal bile duct carcinomas and pancreatic ductal adenocarcinomas: postulating a common tumor entity. Cancer Med 5(1):88\u201399","journal-title":"Cancer Med"},{"issue":"7","key":"4094_CR17","doi-asserted-by":"publisher","first-page":"441","DOI":"10.1002\/jhbp.70","volume":"21","author":"Y Nakanuma","year":"2014","unstructured":"Nakanuma Y, Sato Y (2014) Hilar cholangiocarcinoma is pathologically similar to pancreatic duct adenocarcinoma: suggestions of similar background and development. J Hepatobiliary Pancreat Sci 21(7):441\u2013447","journal-title":"J Hepatobiliary Pancreat Sci"},{"issue":"3","key":"4094_CR18","doi-asserted-by":"publisher","first-page":"319","DOI":"10.1097\/01.coc.0000258124.72884.7a","volume":"30","author":"J Feisthammel","year":"2007","unstructured":"Feisthammel J et al (2007) Irinotecan with 5-FU\/FA in advanced biliary tract adenocarcinomas: a multicenter phase II trial. Am J Clin Oncol 30(3):319\u2013324","journal-title":"Am J Clin Oncol"},{"issue":"3","key":"4094_CR19","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1038\/s41416-018-0138-2","volume":"119","author":"Y Zheng","year":"2018","unstructured":"Zheng Y et al (2018) A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin. Br J Cancer 119(3):291\u2013295","journal-title":"Br J Cancer"},{"issue":"9 Suppl 8","key":"4094_CR20","first-page":"23","volume":"17","author":"P Bhargava","year":"2003","unstructured":"Bhargava P et al (2003) Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer: preliminary report. Oncology (Williston Park) 17(9 Suppl 8):23\u201326","journal-title":"Oncology (Williston Park)"},{"issue":"4","key":"4094_CR21","doi-asserted-by":"publisher","first-page":"501","DOI":"10.1023\/A:1011135014895","volume":"12","author":"PM Sanz-Altamira","year":"2001","unstructured":"Sanz-Altamira PM et al (2001) A phase II trial of irinotecan (CPT-11) for unresectable biliary tree carcinoma. Ann Oncol 12(4):501\u2013504","journal-title":"Ann Oncol"}],"container-title":["Cancer Chemotherapy and Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00280-020-04094-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00280-020-04094-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00280-020-04094-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,17]],"date-time":"2021-06-17T23:21:35Z","timestamp":1623972095000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00280-020-04094-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6,18]]},"references-count":21,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,7]]}},"alternative-id":["4094"],"URL":"https:\/\/doi.org\/10.1007\/s00280-020-04094-0","relation":{},"ISSN":["0344-5704","1432-0843"],"issn-type":[{"value":"0344-5704","type":"print"},{"value":"1432-0843","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,6,18]]},"assertion":[{"value":"20 March 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 June 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 June 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"The authors state that they have no conflicts to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Since this study is retrospective, only the data of the patients were analyzed. Complete anonymity was achieved for all patients. In Austria, there is no need for informed consent, when the conducted study is retrospective and the data are anonymized. Thus, none of the Institutional Ethics Committees required informed consent and all of them have approved this study (Number: 1131\/2019).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"All authors gave their consent for publication of this scientific article.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}