{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T18:50:06Z","timestamp":1789498206597,"version":"build-2803163510"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2022,4,7]],"date-time":"2022-04-07T00:00:00Z","timestamp":1649289600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,4,7]],"date-time":"2022-04-07T00:00:00Z","timestamp":1649289600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Advanced Accelerator Applications (AAA), a Novartis Company"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Nucl Med Mol Imaging"],"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:title>Abstract\n<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>NETTER-R aimed to determine the efficacy, safety and tolerability of <jats:sup>177<\/jats:sup>Lu-DOTATATE in patients with progressive, advanced pancreatic neuroendocrine tumours (panNETs) using retrospective real-world data from multiple sites.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This international study retrospectively included patients with panNETs treated with <jats:sup>177<\/jats:sup>Lu-DOTATATE. The primary endpoint was progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints included overall survival (OS), safety and tumour response.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>In total, 110 patients with panNETs were studied; 65.5% received a cumulative dose of <jats:sup>177<\/jats:sup>Lu-DOTATATE 29.6\u00a0GBq\u2009\u00b1\u200910% (median: 7.4\u00a0GBq). In 62 patients with available RECIST v1.1 tumour response, the median PFS was 24.8\u00a0months (95% confidence interval [CI]: 17.5\u201334.5), and the objective response rate was 40.3% (95% CI: 28.1\u201353.6); all responses were partial. With a median follow up of 24.5\u00a0months (range: 2.0\u2013123.4\u00a0months) after the first cycle of <jats:sup>177<\/jats:sup>Lu-DOTATATE, the median OS in the full analysis set (<jats:italic>n<\/jats:italic>\u2009=\u2009110) was 41.4\u00a0months (95% CI: 28.6\u201350.2). PFS (hazard ratio [HR]: 3.672; <jats:italic>p<\/jats:italic>\u2009=\u20090.0009) and OS (HR: 3.360; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001) were longer in patients who received no chemotherapy prior to <jats:sup>177<\/jats:sup>Lu-DOTATATE than those who did. No treatment-emergent adverse events (TEAEs) led to treatment discontinuation. Grade 3 anaemia, lymphopenia and thrombocytopenia occurred in 0.9%, 5.4% and 0.9% of patients, respectively. No acute leukaemia or myelodysplastic syndrome was reported. Six patients (5.5%) had renal TEAEs. All renal grade\u2009\u2265\u20093 events were transient and did not lead to treatment modification.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>These results reinforce the role of <jats:sup>177<\/jats:sup>Lu-DOTATATE for the treatment of patients with advanced, somatostatin receptor-positive panNETs.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00259-022-05771-3","type":"journal-article","created":{"date-parts":[[2022,4,7]],"date-time":"2022-04-07T04:12:32Z","timestamp":1649304752000},"page":"3529-3537","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Efficacy and safety of 177Lu\u2011DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study"],"prefix":"10.1007","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8116-962X","authenticated-orcid":false,"given":"Dominique","family":"Clement","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaunak","family":"Navalkissoor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9835-8681","authenticated-orcid":false,"given":"Rajaventhan","family":"Srirajaskanthan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1279-2362","authenticated-orcid":false,"given":"Fr\u00e9d\u00e9ric","family":"Courbon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5274-4138","authenticated-orcid":false,"given":"Lawrence","family":"Dierickx","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0561-395X","authenticated-orcid":false,"given":"Amy","family":"Eccles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8521-5478","authenticated-orcid":false,"given":"Valerie","family":"Lewington","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mercedes","family":"Mitjavila","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9244-6872","authenticated-orcid":false,"given":"Juan Carlos","family":"Percovich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beno\u00eet","family":"Lequoy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4115-0115","authenticated-orcid":false,"given":"Beilei","family":"He","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1399-0504","authenticated-orcid":false,"given":"Ilya","family":"Folitar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4824-6600","authenticated-orcid":false,"given":"John","family":"Ramage","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,4,7]]},"reference":[{"key":"5771_CR1","doi-asserted-by":"publisher","first-page":"450","DOI":"10.5946\/ce.2013.46.5.450","volume":"46","author":"MI Park","year":"2013","unstructured":"Park MI. 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While this was a non-interventional study that falls outside of the direct remit of the EU Clinical Trials Directive and therefore the ICH Guideline for Good Clinical Practice (ICH-GCP) does not strictly apply, the study was run according to the principles of the ICH-GCP where appropriate. The study was in accordance with the 1964 Helsinki Declaration and all its amendments up until the 64th World Medical Association (WMA) General Assembly (Fortaleza, Brazil, October 2013), the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP; ) and International Society for Pharmacoepidemiology (ISPE) ), the requirements of the General Data Protection Regulation (GDPR; ) and all applicable laws and regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All study participants (or next of kin in the case of deceased patients, where required according to local regulations) provided written voluntary informed consent to participate in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The authors affirm that the participants of this study provided consent for publication of their data.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"The NETTER-R study was funded by Advanced Accelerator Applications (AAA), a Novartis Company. Dominique Clement has no relevant financial or non-financial interests to disclose. Fr\u00e9d\u00e9ric Courbon has received honoraria from AAA; operated in an advisory role for AAA, Bayer, Vect-Horus and Ipsen; has received compensation to participate in a speakers\u2019 bureau for AAA, Bayer, Global Health Education Consortium (GHEC) and Ipsen; and has received reimbursement from AAA, Bayer, GHEC and Ipsen for travel and accommodation expenses. Lawrence Dierickx has received reimbursement from AAA and Curium for travel and accommodation expenses. Lawrence Dierickx has uncompensated relationships with Novartis and Ipsen. Amy Eccles has received research funding from AAA. Ilya Folitar and Beilei He are employed by Novartis, own stocks in Novartis and have received reimbursement from Novartis for travel and accommodation expenses. Beno\u00eet Lequoy is employed by Novartis and owns stocks in Novartis. Valerie Lewington has been paid honoraria by AAA, Ipsen and Bayer; operated in an advisory role for AAA, Ipsen, Bayer and Nordic Nanovector; received compensation to participate in a speakers\u2019 bureau for AAA, Ipsen and Bayer; and received research funding from AAA. Mercedes Mitjavila held an advisory role for AAA and Sirtex and received reimbursement from AAA and Curium for travel and accommodation expenses. Shaunak Navalkissoor has received compensation for a role in an advisory board of AAA. Juan Carlos Percovich operates in an advisory role for AAA and has received compensation to participate in a speakers\u2019 bureau for AAA. John Ramage has received compensation for a role in advisory boards of Novartis, Ipsen and AAA, as well as for participating in speakers\u2019 bureaus for Novartis, Ipsen and AAA; has received research funding from Novartis, Ipsen and AAA; and has received reimbursement from AAA and Ipsen for travel and accommodation expenses. Rajaventhan Srirajaskanthan has been paid honoraria by AAA and Novartis; has operated in an advisory role for AAA, Novartis and Ipsen; and has received research funding from Ipsen.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Data were collected either by an external researcher or a member of the patient\u2019s care team, as required according to local regulations. Prespecified information was collected in the study-specific electronic case report forms.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data collection"}},{"value":"United Kingdom\u2022 Common Law Duty of Confidentiality \u2022 NHS Code of Practice \u2022 UK Data Protection Act, 1998 \u2022 GDPR France\u2022 Research involving human subjects: Law n\u00b02012-300 of 5th March 2012, Ordinance n\u00b0 2016-800 of 16th June 2016, French Public Health Code \u2022 Data protection <u>, <\/u>\u2022 GDPR Spain\u2022 121\/000013 Proyecto de Ley Org\u00e1nica de Protecci\u00f3n de Datos de Car\u00e1cter Personal (came into force on 25th May 2018) \u2022 Local regulation for conduct post-authorisation studies\u2022 Orden SAS\/3470\/2009, 16th December 2009","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data collection and informed consent regulation"}}]}}