{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T12:24:47Z","timestamp":1789043087298,"version":"build-2803163510"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2020,10,14]],"date-time":"2020-10-14T00:00:00Z","timestamp":1602633600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,10,14]],"date-time":"2020-10-14T00:00:00Z","timestamp":1602633600000},"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":["Endocrine"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>In the phase III CLARINET study (NCT00353496), lanreotide autogel\/depot (lanreotide) significantly improved progression-free survival (PFS) vs placebo in patients with non-functioning intestinal or pancreatic neuroendocrine tumours (NETs). The aim of CLARINET open-label extension (OLE) (NCT00842348) was to evaluate long-term safety and efficacy of lanreotide in these patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120\u2009mg every 28 days. Computed tomography or magnetic resonance imaging scans were conducted every 6 months and assessed locally for PD (the final scan was also assessed centrally).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Overall, 89 patients took part in the OLE (lanreotide, <jats:italic>n<\/jats:italic>\u2009=\u200942; placebo, <jats:italic>n<\/jats:italic>\u2009=\u200947). Median (range) exposure to lanreotide in patients who received lanreotide in the core study and OLE (LAN\u2013LAN group) was 59.0 (26.0\u2013102.3) months. In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study. Median [95% CI] PFS in the LAN\u2013LAN group was 38.5 [30.9; 59.4] months. In placebo-treated patients with PD at the end of the core study, time to death or subsequent PD during the OLE was 19 [10.1; 26.7] months.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This study provides new evidence on the long-term safety profile and sustained anti-tumour effects of lanreotide autogel\/depot in indolent and progressive metastatic intestinal or pancreatic NETs.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s12020-020-02475-2","type":"journal-article","created":{"date-parts":[[2020,10,14]],"date-time":"2020-10-14T14:03:14Z","timestamp":1602684194000},"page":"502-513","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":77,"title":["Lanreotide autogel\/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study"],"prefix":"10.1007","volume":"71","author":[{"given":"Martyn E.","family":"Caplin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne","family":"Pavel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandria T.","family":"Phan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaros\u0142aw B.","family":"\u0106wik\u0142a","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Sedl\u00e1\u010dkov\u00e1","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuan-Mai Truong","family":"Thanh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward M.","family":"Wolin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Ruszniewski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the CLARINET Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,10,14]]},"reference":[{"issue":"3","key":"2475_CR1","doi-asserted-by":"publisher","first-page":"224","DOI":"10.1056\/NEJMoa1316158","volume":"371","author":"ME Caplin","year":"2014","unstructured":"M.E. Caplin, M. Pavel, J.B. Cwikla, A.T. Phan, M. Raderer, E. Sedlackova, G. Cadiot, E.M. Wolin, J. Capdevila, L. Wall, G. Rindi, A. Langley, S. Martinez, J. Blumberg, P. Ruszniewski, C. Investigators, Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med 371(3), 224\u2013233 (2014). https:\/\/doi.org\/10.1056\/NEJMoa1316158","journal-title":"N Engl J Med"},{"key":"2475_CR2","unstructured":"Ipsen Biopharmaceuticals, I.: Somatuline Depot Prescribing Information. https:\/\/www.ipsen.com\/websites\/Ipsen_Online\/wp-content\/uploads\/sites\/9\/2019\/06\/24155556\/Somatuline_Depot_Full_Prescribing_Information.pdf (2019). Accessed Jul 2019"},{"key":"2475_CR3","unstructured":"Ipsen Ltd.: Somatuline\u00ae Autogel\u00ae summary of product characteristics. https:\/\/www.medicines.org.uk\/emc\/product\/8257\/smpc (2019). 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M.P.: Honoraria for presentation and advisory boards\u2014Ipsen; research grants\u2014Ipsen to former institution (Charit\u00e9 University Medicine, Berlin). A.T.P.: Research funding\u2014Ipsen, Sanofi and Incyte; consulting\/advisory fees\u2014Ipsen and Roche; speaker fees\u2014Lexicon, Novartis and Ipsen. JBC: Research funding and travel grant\u2014Ipsen. E.S.: Travel grants and speaker fees\u2014Ipsen and Novartis. E.M.W.: Consultancy\/advisory fees\u2014Ipsen, Novartis, Lexicon and Progenics. P.R.: Research funding\u2014Ipsen; speaker fees \u2013 Ipsen, Novartis, AAA, ITM; consultancy\u2014Ipsen, Novartis, AAA, ITM. X-MTT: Ipsen employee.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was conducted under the provisions of the Declaration of Helsinki [], and in accordance with the International Conference on Harmonisation Consolidated Guideline on Good Clinical Practice []. The study also adhered to all local regulatory requirements. Protocol amendments after the start of the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all patients before enrolment into the OLE, prior to any study-specific procedures.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}