{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T22:19:37Z","timestamp":1790720377324,"version":"4.1.0"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"11","license":[{"start":{"date-parts":[[2024,5,22]],"date-time":"2024-05-22T00:00:00Z","timestamp":1716336000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,5,22]],"date-time":"2024-05-22T00:00:00Z","timestamp":1716336000000},"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":["Eur J Nucl Med Mol Imaging"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>Gastroenteropancreatic\n-neuroendocrine tumours (GEP-NETs) are commonly treated with surgical resection or long-term therapies for tumour growth control. Lutetium [<jats:sup>177<\/jats:sup>Lu]-DOTA-TATE was approved for the treatment of GEP-NETs after the phase III NETTER 1trial demonstrated improved progression free survival, objective response rates and health-related quality of life (HRQoL) compared to high-dose somatostatin analogues.<\/jats:p>\n                <jats:p>No real-world data exist on prescribing habits and clinically significant endpoints for [<jats:sup>177<\/jats:sup>Lu]Lu-DOTA-TATE treatment in Italy. REAL-LU is a multicentre, long-term observational study in patients with unresectable\/metastatic GEP-NETs progressing on standard therapies in Italian clinical practice. A pre-specified interim analysis was performed at the end of the enrolment period, data from which are described herein.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Overall duration of REAL-LU will be approximately 48\u00a0months, with 12- and 36-month recruitment and follow-up periods, respectively. The primary objective is to evaluate [<jats:sup>177<\/jats:sup>Lu]Lu-DOTA-TATE effectiveness in terms of progression-free survival. Secondary objectives include safety, impact on HRQoL, and identification of prognostic factors. This pre-specified interim analysis describes patient profiles, at the end of enrollment, of those prescribed [<jats:sup>177<\/jats:sup>Lu]Lu-DOTA-TATE for GEP-NETs in Italy.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Among 161 evaluable patients, mean age was 64.7\u2009\u00b1\u200910.3\u00a0years at study entry, 83.8% presented with no clinical signs of disease at physical examination, and most had minor disease symptoms. All patients had metastatic disease, most commonly in the liver (83.9%) with a median of two metastatic sites. In 90.7% of patients, the disease was stage IV, and 68.3% had\u2009\u2265\u20091 target lesion. [<jats:sup>177<\/jats:sup>Lu]Lu-DOTA-TATE was prescribed mainly as second-line therapy (61.6%) and following surgery (58.4%). HRQoL assessments revealed high levels of functioning and low levels of symptoms at baseline; 50.0% of patients were symptom-free at study entry.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The characteristics of patients who received [177Lu]Lu-DOTA-TATE in Italy are similar to those of the GEP-NET population of NETTER 1 with trial but with a higher proportion of patients with a grade 2 (71%). With regard to the tumor grade profile, our study cohort appears to be closer to that of NETTER-2 study population which included patients with G2 or G3 advanced GEP-NETs (i.e. Ki-67\u2009\u2265\u200910% and\u2009\u2264\u200955%). Further analysis of effectiveness and safety can be anticipated as REAL-LU data mature.<\/jats:p>\n                <jats:p>Study Registration: ClinicalTrials.gov, NCT04727723; Study Registration Date: 25 January, 2021; <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT04727723?cond=NCT04727723&amp;rank=1\">https:\/\/clinicaltrials.gov\/study\/NCT04727723?cond=NCT04727723&amp;rank=1<\/jats:ext-link><\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00259-024-06725-7","type":"journal-article","created":{"date-parts":[[2024,5,22]],"date-time":"2024-05-22T02:01:25Z","timestamp":1716343285000},"page":"3417-3427","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Lutetium [177Lu]-DOTA-TATE in gastroenteropancreatic-neuroendocrine tumours: rationale, design and baseline characteristics of the Italian prospective 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Additionally, the strict monitoring and reporting requirements relating to [<sup>177<\/sup>Lu]Lu-DOTA-TATE use as stipulated by AIFA are being followed.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"Secondo Lastoria has received fees for participating on Advanced Accelerator Applications (AAA) advisory boards. Ettore Seregni has received speaker fees and fees for bureau services from AAA. Anna Rita Cervino participated in editorial project for Advanced Accelerator Applications (AAA). Angelina Filice participated in editorial projects for Advanced Accelerator Applications (AAA). All remaining authors declare no competing interests.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}