NANETS2025 18th Annual Multidisciplinary NET Medical Symposium NANETS 2025 Clinical – Nuclear Medicine/Interventional Radiology/Imaging (22 abstracts)
Efficacy and safety of [177Lu]Lu-edotreotide ([177Lu]Lu-DOTATOC) for the treatment of neuroendocrine tumors (NETs) – a systematic literature review (SLR) and meta-analysis
Julia Fricke 1 , Holger Amthauer 2 , Azorin-Vega Erika Patricia 3 , Richard Paul Baum 4 , Dieter Hörsch 5 , Riccardo Laudicella 6 , Tristan Ruhwedel 2 , Martin Alexander Walter 7 , Vikalp Maheshwari 8 , Berna Degirmenci Polack 9 , Spiegl Simon Florian 10 & Guillaume P Nicolas 1
1University Hospital Basel, Division of Nuclear Medicine, ENETS Centre of Excellence (CoE), Basel, Switzerland; 2Charité – Universitätsmedizin Berlin, corporate member of the Free University of Berlin and of Humboldt University of Berlin, Department of Nuclear Medicine, Berlin, Germany; 3Instituto Nacional de Investigaciones Nucleares (ININ), Department of Radioactive Materials, State of Mexico, Mexico; 4Curanosticum Wiesbaden-Frankfurt, Advanced Theranostics Center for Radiomolecular Precision Oncology and Deutsche Klinik für Diagnostik (DKD HELIOS Klinik), Wiesbaden, Germany; 5Zentralklinik Bad Berka GmbH, Bad Berka, Germany; 6University of Messina, Nuclear Medicine, Department of Biomedical and Dental Sciences and Morpho-Functional Imaging, Messina, Italy; 7St. Anna Hospital, Department of Nuclear Medicine and University of Lucerne, Lucerne, Switzerland; 8Parexel International, Hyderabad, India; 9ITM USA Inc., Princeton, US; 10ITM Oncologics GmbH, Garching/Munich, Germany
Background: [177Lu]Lu-edotreotide represents a promising radiopharmaceutical therapy (RPT) currently undergoing clinical evaluation for its efficacy in the management of patients with advanced NETs. No meta-analysis of data has previously been published for [177Lu]Lu-edotreotide in this clinical setting.
Methods: PubMed, EMBASE, Cochrane databases, and abstracts from select congresses were searched for eligible [177Lu]Lu-edotreotide studies (PROSPERO 2024 CRD42024518028). Meta-analyses were performed using fixed and random-effects models. The primary outcome was the objective response rate (ORR; complete + partial response) in the subgroup of patients with gastroenteropancreatic NETs (GEP-NETs) and in those with any NETs, irrespective of origin (All-NETs). Secondary outcomes included disease control rate (DCR; best overall response of complete response + partial response + stable disease), median progression-free survival (mPFS), and median overall survival (mOS). Safety/tolerability data for [177Lu]Lu-edotreotide were reviewed but not analyzed. Unpublished/updated data were requested from the authors where needed, to permit additional analyses.
Results: Of 591 unique publications identified in the searches, eight studies were eligible for inclusion, all in the advanced disease setting (5/8 included patients with progressive NETs). Updated data were included from 4/8 studies (maximum n = 294 GEP-NETs; n = 489 All-NETs). Most patients had grade 1/2 NETs (grade 1: 11%–63%; 2: 30%–79%; 3: 4%–11%). The response was assessed using RECIST-based criteria in 4/8 studies. There was high heterogeneity (I² >70%) across meta-analysis outcomes/patient populations, therefore, results from the more conservative random-effects model were prioritized. Patients with GEP-NETs had better RPT efficacy outcomes than those with All-NETs (Table). Safety/tolerability data were inconsistently reported, but grade 3/4 hematological, renal and hepatic toxicities were rarely noted during [177Lu]Lu-edotreotide treatment. No secondary malignancies were reported in patients receiving RPT with [177Lu]Lu-edotreotide alone.
| GEP-NETs | All-NETs | |
| ORR, % (95% CI) | 34 (17–54) [n = 222] | 19 (8–32) [n = 423] |
| DCR, % (95% CI) | 78 (60–92) [n = 222] | 57 (33–79) [n = 423] |
| mPFS, months (95% CI) | 24.9 (17.6–32.2) [n = 294] | 18.6 (12.5–24.8) [n = 267] |
| mOS, months (95% CI) | 44.8 (36.8–52.8) [n = 256] | 39.1 (25.1–53.0) [n = 408] |
| CI = confidence interval; n = number of patients in analysis | ||
Conclusions: Overall, these results show favorable efficacy for [177Lu]Lu-edotreotide in patients with advanced NETs, especially in those with GEP-NETs. Response and PFS outcomes were encouraging in relation to recent phase 3 [177Lu]Lu-edotreotide data from COMPETE. The safety/tolerability profile of [177Lu]Lu-edotreotide also appears to be good and in line with the findings in COMPETE.
Abstract ID #33271
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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