Lutetium [ 177 Lu]-DOTA-TATE in gastroenteropancreatic-neuroendocrine tumours: rationale, design and baseline characteristics of the Italian prospective observational (REAL-LU) study.

Autor: Lastoria S; Division of Nuclear Medicine, IRCCS Istituto Nazionale Tumori, 'Fondazione Senatore Giovanni Pascale', Naples, Italy., Rodari M; Nuclear Medicine Unit, IRCCS-Humanitas Clinical and Research Hospital, Rozzano, MI, Italy., Sansovini M; Nuclear Medicine Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST), 'Dino Amadori', Meldola, Italy., Baldari S; Department of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, Messina, Italy. sbaldari@unime.it., D'Agostini A; U.O.C. Medicina Nucleare-Ospedale 'S.M. Goretti', Latina, Italy., Cervino AR; Nuclear Medicine Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy., Filice A; Nuclear Medicine Unit, AUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy., Salgarello M; Nuclear Medicine Department, Sacrocuore-Don Calabria Hospital, Negrar di Valpolicella, Italy., Perotti G; Nuclear Medicine Unit, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy., Nieri A; Nuclear Medicine Unit, Onco-Hematological Department, University Hospital of Ferrara, Ferrara, Italy., Campana D; Oncology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Pellerito RE; Nuclear Medicine Unit, Ordine Mauriziano Hospital, Turin, Italy., Pomposelli E; SC Medicina Nucleare, Azienda Ospedaliera-Universitaria SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy., Gaudieri V; Department of Advanced Biomedical Sciences, University ''Federico II'' of Naples, Naples, Italy., Storto G; IRCCS CROB Referral Cancer Center of Basilicata, Rionero in Vulture (Pz), Italy., Grana CM; Radiometabolic Therapy, Nuclear Medicine, IRCCS European Institute of Oncology, Milan, Italy., Signore A; Nuclear Medicine Unit, Department of Medical-Surgical Sciences and Translational Medicine, University Hospital Sant'Andrea, 'Sapienza' University of Rome, Rome, Italy., Boni G; Nuclear Medicine Therapy Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, 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., Seregni E; Nuclear Medicine Unit, IRCCS-Fondazione Istituto Nazionale dei Tumori, Milan, Italy.
Jazyk: angličtina
Zdroj: European journal of nuclear medicine and molecular imaging [Eur J Nucl Med Mol Imaging] 2024 Sep; Vol. 51 (11), pp. 3417-3427. Date of Electronic Publication: 2024 May 22.
DOI: 10.1007/s00259-024-06725-7
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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