Lutetium [(177)Lu]-DOTA-TATE in gastroenteropancreatic-neuroendocrine tumours: rationale, design and baseline characteristics of the Italian prospective observational (REAL-LU) study. in European journal of nuclear medicine and molecular imaging / Eur J Nucl Med Mol Imaging. 2024 Sep;51(11):3417-3427. doi: 10.1007/s00259-024-06725-7. Epub 2024 Ma
2024
AOU Alessandria
AO Ordine Mauriziano
Tipo pubblicazione
Observational Study
Autori/Collaboratori (21)Vedi tutti...
Seregni E
Nuclear Medicine Unit, IRCCS-Fondazione Istituto Nazionale dei Tumori, Milan, Italy.
Dondi F
Nuclear Medicine, ASST Spedali Civili di Brescia, Brescia, Italy.
Simontacchi G
SODc Radiotherapy, Department of Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
et alii...
Abstract
PURPOSE: Gastroenteropancreatic -neuroendocrine tumours (GEP-NETs) are commonly treated with surgical resection or long-term therapies for tumour growth control. Lutetium [(177)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. No real-world data exist on prescribing habits and clinically significant endpoints for [(177)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. METHODS: Overall duration of REAL-LU will be approximately 48 months, with 12- and 36-month recruitment and follow-up periods, respectively. The primary objective is to evaluate [(177)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 [(177)Lu]Lu-DOTA-TATE for GEP-NETs in Italy. RESULTS: Among 161 evaluable patients, mean age was 64.7?±?10.3 years 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???1 target lesion. [(177)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. CONCLUSION: 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???10% and???55%). Further analysis of effectiveness and safety can be anticipated as REAL-LU data mature. STUDY REGISTRATION: ClinicalTrials.gov, NCT04727723; Study Registration Date: 25 January, 2021; https://clinicaltrials.gov/study/NCT04727723?cond=NCT04727723&rank=1.
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PMID : 38772998
DOI : 10.1007/s00259-024-06725-7
Keywords
Peptide receptor radionuclide therapy; Italy; Quality of Life; Radiopharmaceuticals/therapeutic use; Gastroenteropancreatic-neuroendocrine tumours; Lutetium/therapeutic use; Adult; Organometallic Compounds/therapeutic use; Intestinal Neoplasms/radiotherapy; Aged; Octreotide/analogs & derivatives/therapeutic use; Prospective Studies; Middle Aged; Italy; Stomach Neoplasms/radiotherapy; Pancreatic Neoplasms/radiotherapy; Female; Male; Neuroendocrine Tumors/radiotherapy/pathology; Humans; REAL-LU; Real-world; [177Lu]Lu-DOTA-TATE;