26 augustus 2026: Bron: eClinicalMedicin
Eerstelijnsbehandeling met lutetium-177Lu-dotatate is een inwendige bestraling van vooral het beenmerg / ruggegraat plus octreotide (Sandostatin) in een langwerkende, herhaalbare vorm heeft een duurzame werkzaamheid aangetoond, ongeacht de tumorgradering of de plaats van oorsprong, bij patiënten met gevorderde, goed gedifferentieerde, somatostatinereceptor positieve GEP-NET tumoren = gastro-enteropancreatische neuro-endocriene tumoren.
De onderzoekers lichten het nut en de waarde van deze studie uitvoerig toe. Ik heb deze toelichting vertaald:
Bewijs vóór dit onderzoek:
Somatostatine-analogen waren eerder vastgesteld als de standaardbehandeling voor patiënten met gevorderde gastro-enteropancreatische neuro-endocriene tumoren (GEP-NET's) van graad 1 en 2, gebaseerd op de fase 3 PROMID- en CLARINET-studies.
Vervolgens bevestigde de fase 3 NETTER-1-studie de werkzaamheid en veiligheid van de radioligandtherapie lutetium-177Lu-dotatate in combinatie met octreotide langwerkend en herhaalbaar (LAR) 30 mg bij patiënten met gevorderde somatostatinereceptor positieve NET's van graad 1 en 2 van de middendarm die progressie vertoonden na behandeling met Somatostatine-analogen.
Op basis van deze resultaten werd lutetium-177Lu-dotatate de standaardbehandeling voor deze patiëntenpopulatie.
Ondanks deze vooruitgang ontbrak het aan gegevens ter ondersteuning van eerstelijnsbehandelingen voor patiënten met gevorderde, goed gedifferentieerde GEP-NET's van graad 2 en 3. Deze patiënten hebben een slechte prognose in vergelijking met patiënten met een lagergradige ziekte en vertegenwoordigen een aanzienlijke onvervulde klinische behoefte aan nieuwe behandelingen.
In deze context was NETTER-2 de eerste gerandomiseerde studie die een radioligandtherapie als eerstelijnsbehandeling voor welke maligniteit dan ook onderzocht.
De primaire analyse toonde aan dat lutetium-177Lu-dotatate plus octreotide LAR 30 mg de progressievrije overleving verlengde bij patiënten met nieuw gediagnosticeerde, gevorderde, goed gedifferentieerde,somatostatinereceptor positieve GEP-NET's van graad 2 en 3 in vergelijking met de controlegroep (hooggedoseerde octreotide LAR 60 mg).
Gezien de heterogeniteit van GEP-NET's is subgroepanalyse op basis van tumorgraad en primaire tumorlocatie bijzonder belangrijk om de behandelingseffecten in verschillende patiëntenpopulaties beter te begrijpen.
Toegevoegde waarde van deze studie:
Hoewel de primaire resultaten van NETTER-2 studie aangeven dat lutetium-177Lu-dotatate effectief is bij patiënten met gevorderde, goed gedifferentieerde, hogere graad 2 of graad 3, somatostatinereceptor-positieve GEP-NET's, is een uitgebreider inzicht in de behandelingseffecten in specifieke patiëntenpopulaties nodig.
In onze vooraf geplande analyses van patiëntsubgroepen uit NETTER-2 studie werd een voordeel in progressievrije overleving en objectieve responspercentage ten gunste van lutetium-177Lu-dotatate waargenomen in alle evalueerbare subgroepen, ongeacht de NET-graad (2 versus 3), de plaats van oorsprong (pancreas versus gastro-intestinaal) of de somatostatinereceptor opnamescore (3 versus 4).
Aanvullende post-hoc subgroepanalyses suggereren dat het voordeel in progressievrije overleving en objectieve responspercentage van lutetium-177Lu-dotatate ten opzichte van de controle consistent is, ongeacht de NET-graad en de plaats van oorsprong.
Bovendien bleken de behandelingseffecten op de progressievrije overleving en de objectieve responsratio in post-hoc analyses minimaal beïnvloed te worden na correctie voor baseline covariaten met behulp van multivariate regressiemodellen.
Onze resultaten bieden een uitgebreider inzicht in het effect van lutetium-177Lu-dotatate in verschillende populaties. Dit zal zorgprofessionals helpen om weloverwogen behandelbeslissingen te nemen en de uitkomsten voor patiënten met GEP-NET's van graad 2-3 te verbeteren.
Implicaties van al het beschikbare bewijs
Deze werkzaamheidsanalyses bieden aanvullende inzichten in het klinische voordeel van lutetium-177Lu-dotatate in verschillende patiëntsubgroepen. De bevindingen vullen de primaire uitkomsten van NETTER-2 studie aan en ondersteunen het gebruik van lutetium-177Lu-dotatate als eerstelijnsbehandeling bij patiënten met gevorderde, goed gedifferentieerde, somatostatinereceptor positieve GEP-NET's van graad 2-3, ongeacht de NET-graad (2 versus 3) of de plaats van oorsprong (pancreas versus gastro-intestinaal) en ongeacht de somatostatinereceptor opnamescore (3 versus 4).
Het volledige studierapport is gratis in te zien en te downloaden, zie hier het abstract:
[177Lu]Lu-DOTA-TATE plus long-acting octreotide in patients with newly diagnosed, advanced, grade 2–3, gastroenteropancreatic neuroendocrine tumours: preplanned and post-hoc efficacy analyses from the randomised, phase 3 NETTER-2 trial
Affiliations & Notes
Article Info
Publication History:
Received January 7, 2026; Revised June 29, 2026; Accepted July 8, 2026; Published August 7, 2026
DOI: 10.1016/j.eclinm.2026.104109 External LinkAlso available on ScienceDirect External Link
Copyright: © 2026 The Authors. Published by Elsevier Ltd.
Summary
Background
In the phase 3 NETTER-2 study, first-line [177Lu]Lu-DOTA-TATE (hereafter 177Lu-DOTATATE) significantly improved progression-free survival in patients with advanced, well-differentiated, higher grade 2–3 (Ki67 ≥10% and ≤55%), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Median progression-free survival was 22·8 months (95% CI 19·4–not estimable ) with 177Lu-DOTATATE vs 8·5 months (7·7–13·8) in the control arm. Here, we report subgroup analyses, including preplanned assessments of efficacy by NET grade (G) and site of origin; further post-hoc analyses are reported in the main text.
Methods
In this open-label, parallel-group study, patients from nine countries were randomised 2:1 to receive four cycles of 177Lu-DOTATATE plus octreotide long-acting repeatable (LAR) 30 mg every 8 weeks then octreotide LAR 30 mg every 4 weeks, or high-dose octreotide LAR 60 mg every 4 weeks. The primary endpoint (progression-free survival) was previously reported. Tumours were assessed at baseline, week 16, week 24, then every 12 weeks until disease progression or death. Preplanned subgroup analyses used blinded independent centrally reviewed data. The study is registered with ClinicalTrials.gov, NCT03972488, and is completed.
Findings
Between Jan 22, 2020, and Oct 13, 2022, 261 patients were screened; 35 were excluded due to screen failure, and 226 were randomised. 177Lu-DOTATATE (n = 151) reduced risk of disease progression/death vs control (n = 75) regardless of NET grade/origin (hazard ratio [95% CI]: G2 NET 0·31 [0·18–0·53]; G3 NET 0·27 [0·14–0·49]; pancreatic NET 0·34 [0·20–0·56]; gastrointestinal NET 0·23 [0·12–0·46]). Median progression-free survival in months (95% CI) with 177Lu-DOTATATE was: G2 NET 29·0 (21·8–NE); G3 NET 22·2 (13·9–27·8); pancreatic NET 19·4 (16·6–24·9); gastrointestinal NET NE (22·6–NE). 177Lu-DOTATATE improved objective response rate vs control regardless of NET grade/origin.
Interpretation
These findings support the use of first-line 177Lu-DOTATATE for patients with advanced, well-differentiated, higher grade 2–3 (Ki67 ≥10% and ≤55%), somatostatin receptor-positive GEP-NETs, and for whom chemotherapy is not considered the most appropriate treatment option, regardless of NET grade (2/3) or origin (pancreas/gastrointestinal).
Funding
Advanced Accelerator Applications, a Novartis Company.
Research in context
Evidence before this study
Somatostatin analogues were previously established as the standard of care for patients with advanced grade 1 and grade 2 gastroenteropancreatic neuroendocrine tumours (GEP-NETs) based on the phase 3 PROMID and CLARINET studies. Subsequently, the phase 3 NETTER-1 trial established the efficacy and safety of the radioligand therapy [177Lu]Lu-DOTA-TATE (hereafter 177Lu-DOTATATE) in combination with octreotide long-acting repeatable (LAR) 30 mg in patients with advanced somatostatin receptor (SSTR)-positive grade 1 and grade 2 midgut NETs who had progressed on somatostatin analogues. Based on these results 177Lu-DOTATATE became the standard of care in this patient population.
Despite these advances, there were a lack of data to support first-line treatment options for patients with advanced higher grade 2 and grade 3 well-differentiated GEP-NETs. These patients have a poor prognosis compared with those who have lower-grade disease and represent a significant clinical unmet need. In this context, NETTER-2 was the first randomised study to investigate a radioligand therapy as a first-line treatment for any malignancy. The primary analysis found that 177Lu-DOTATATE plus octreotide LAR 30 mg prolonged progression-free survival in patients with newly diagnosed, advanced, well-differentiated, higher grade 2 and grade 3, SSTR-positive GEP-NETs compared with control (high-dose octreotide LAR 60 mg). Given the heterogeneity of GEP-NETs, subgroup analysis by tumour grade and primary tumour site are particularly important to better understand treatment effects across different patient populations.
Added value of this study
While the primary results of NETTER-2 indicate that 177Lu-DOTATATE is efficacious in patients with advanced, well-differentiated, higher grade 2 or grade 3, somatostatin receptor-positive GEP-NETs, a more comprehensive understanding of treatment effects in specific patient populations is required. In our preplanned analyses of patient subgroups from NETTER-2, a progression-free survival and objective response rate benefit in favour of 177Lu-DOTATATE was observed across all evaluable subgroups regardless of NET grade (2 vs 3), site of origin (pancreas vs gastrointestinal), or somatostatin receptor uptake score (3 vs 4). Additional post-hoc subgroup analyses suggest that the progression-free survival and objective response rate benefit of 177Lu-DOTATATE vs control is consistent regardless of NET grade plus site of origin. Furthermore, in post-hoc analyses, treatment effects on progression-free survival and objective response rate appeared to be minimally affected when adjusted for baseline covariates using multivariate regression models. Our results provide a more comprehensive understanding of the effect of 177Lu-DOTATATE in different populations. This will help healthcare professionals to make informed treatment decisions and improve outcomes for patients with higher grade 2–3 GEP-NETs.
Implications of all the available evidence
These efficacy analyses provide additional insights into the clinical benefit of 177Lu-DOTATATE across different patient subgroups. The findings supplement the primary outcomes of NETTER-2 and support the use of first-line 177Lu-DOTATATE in patients with advanced, well-differentiated, higher grade 2–3, somatostatin receptor-positive GEP-NETs, regardless of NET grade (2 vs 3) or site of origin (pancreas vs gastrointestinal) and regardless of the somatostatin receptor uptake score (3 vs 4).
Data sharing statement
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymised to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Declaration of interests
DF reports grants or contracts from Camurus, honoraria from Advanced Accelerator Applications (a Novartis company) and Recordati Rare Diseases, advisory board participation for Recordati Rare Diseases, support for attending meetings from Camurus and Recordati Rare Diseases, and is the president elect of the Italian Society of Endocrinology. MP reports consulting fees from Advanced Accelerator Applications (a Novartis company), Boehringer Ingelheim, Ipsen, and ITM, honoraria from Advanced Accelerator Applications (a Novartis company), Boehringer Ingelheim, Ipsen, Lilly, Medscape, Merck, MSD, Novartis, Recordati, Sanofi, Serb, and Tairix, travel support from ENETS, Ipsen, and Recordati, safety monitoring committee membership for Advanced Accelerator Applications (a Novartis company), Crinetics, and the Gustave Roussy Institute (University Paris, Villejuif), and unpaid roles as AIO NET group leader of the German Cancer Foundation, ENETS advisory board member, ESMO education committee member, and as advisory board member for Netzwerk NET and INCA. KH reports grants or contracts from Novartis and SOFIE Biosciences, consulting fees from Advanced Accelerator Applications (a Novartis company), Amgen, AstraZeneca, Bain Capital, Bayer, Boston Scientific, Convergent, Curium, Debiopharm, EcoR1, Fusion, GE Healthcare, Immedica, Isotopen Technologien München, Janssen, Merck, Molecular Partners, NVision, Pfizer, POINT Biopharma, Radiopharm Theranostics, Rhine Pharma, Siemens Healthineers, SOFIE Biosciences, Telix, Theragnostics, and Y-mAbs, honoraria from PeerVoice, meeting support from Janssen, advisory board participation for Fusion and GE Healthcare, and stock or stock options for AdvanCell, Aktis Oncology, Convergent, NVision, Pharma15, and SOFIE Biosciences. PLK reports grants or contracts from Crinetics, Novartis, and RayzeBio. SM reports honoraria from Ipsen and Novartis Oncology, and support for attending meetings from Novartis Oncology. DH reports support for the present work from Novartis, grants or contracts from Camurus, Chimeric Therapeutics, Crinetics Pharmaceuticals, Genentech/Roche, ITM, Novartis, RayzeBio, and Thermo Fisher Scientific, consulting fees from AbbVie, Amryt, Boehringer Ingelheim, Camurus, Chimeric Therapeutics, Crinetics, Exelixis, HarbourBioMed, Harpoon Therapeutics, Ipsen, ITM, Lantheus, Novartis, Sanofi Aventis, TerSera, and Wren Laboratories, and participation on a Data Safety Monitoring Board for Alphamedix. BC reports advisory board participation for Advanced Accelerator Applications (a Novartis company) and Lantheus. JC reports grants or contracts from Advanced Accelerator Applications (a Novartis company), Bayer, Eisai, Esteve, Exelixis, Ipsen, Isotopen Technologien, Lilly, Merck Serono, Novartis, Pfizer, Roche/Genentech, and Sanofi, honoraria from Bayer, Eisai, Esteve, Hutchison MediPharma, Ipsen, Isotopen Technologien, Lilly, Merck Serono, Novartis, Pfizer, and Sanofi, and support for attending meetings from Eisai, Ipsen, and Pfizer. AG-B reports advisory/consulting fees from Advanced Accelerator Applications (a Novartis company), Bayer, and Sanofi, and speaker fees and meeting support from Novartis. ST reports consulting fees from Boehringer Ingelheim, Camurus, Deciphera, Esteve, Gentili, Ipsen, and Novartis. SL reports honoraria from, and advisory board participation for, Advanced Accelerator Applications (a Novartis company). D-YO reports grants or contracts from Array, AstraZeneca, BeiGene, Eli Lilly, Handok, Hanmi, MSD, Novartis, and Servier, and advisory board participation for AbbVie, Alligator Bioscience AB, ASLAN, Arcus Biosciences, Astellas, AstraZeneca, Basilea, Bayer, BeiGene, BMS/Celgene, Daewoong, Eutilex, Genentech/Roche, Halozyme, Hana Pharm, Hanmi, Idience, IQVIA, J-Pharma, LG Chem, Merck Serono, Mirati Therapeutics, Moderna, MSD, Novartis, Pfizer, Revolution Medicine, Taiho, Tallac Therapeutics, Turning Point, Yuhan, and Zymeworks. CY reports support for the present work from Novartis, grants or contracts from AstraZeneca, Bayer, Boehringer Ingelheim, Boryung, CKD Pharm, Ipsen, Lunit Inc, Ono Pharmaceuticals, and Servier, and honoraria from AstraZeneca, Autem Therapeutics, Bayer, Boehringer Ingelheim, Boryung, Bristol Myers Squibb, Celgene, Eisai, Elevar Therapeutics, HLB, Ipsen, MSD, Novartis, Qurient, Roche, and Servier. SF has nothing to declare. TRH reports grants from Advanced Accelerator Applications (a Novartis company), Camurus, Crinetics, ITM, Perspective Therapeutics, Rezolute, and Thermo Fisher Scientific, consulting fees from Abdera Therapeutics, Advanced Accelerator Applications (a Novartis company), Boehringer Ingelheim, Camurus, Crinetics, Curium, Exelixis, ITM, Perspective Therapeutics, Sanofi, and TerSera, honoraria from Banner MD Anderson, Binaytera Foundation, ISGIO Physicians’ Education Resource® LLC (PER®), and MD Education Ltd, and was president of NANETs from October 2023 to November 2024. MS has nothing to declare. LG reports honoraria from Advanced Accelerator Applications (a Novartis company). ED reports honoraria from GE, Ipsen, Janssen, and Novartis, support for attending meetings from GE and Novartis, advisory board participation for Ipsen and Novartis, and has an unpaid role as general secretary of the French Society of Nuclear Medicine. AF reports honoraria from GE Healthcare and Novartis, advisory board participation for Novartis, and support for meeting attendance from Bayer, GE Healthcare, and Novartis. IF and YZ report employment by Novartis and stock or stock options for Novartis. WWdH reports advisory board participation for Camurus, Ipsen, and Novartis, receiving travel grants from Recordati, and participation on data safety monitoring boards for trials sponsored by Erasmus MC and Rare Thyroid Therapeutics International AB. SS reports support for the present work from Advanced Accelerator Applications (a Novartis company), grants or contracts from Novartis, consulting fees from Camurus, Ipsen, and Novartis, and meeting attendance support from Ipsen and Novartis.
Acknowledgements
This study was funded by Advanced Accelerator Applications, a Novartis company. We thank all patients and their families, research nurses, trial coordinators, and operations staff for their contributions. We are also grateful to Paola Santoro for her contribution to the conduct of the study. Medical writing support, including development of a draft outline and subsequent drafts in consultation with the authors, collating author comments, copyediting, fact checking, and referencing, was provided by Ryan Riley, PhD, and Lauren McNally, MSci, CMPP, at Aspire Scientific Limited (Manchester, UK). Funding for medical writing support for this Article was provided by Advanced Accelerator Applications, a Novartis company.
Appendix A Supplementary data (3)
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- Peptide Receptor Radionuclide Therapie (PRRT) geeft uitstekende resultaten - 4 tot 6 jaar langere overleving - bij patiënten met neuro endocriene tumoren
- Sandostatine LAR (langwerkend octreotide-acetaat). werkt uitstekend bij patiënten met Carcinoid Syndroom - Carcinoide tumoren, aldus studie uit Engeland, maar wordt ook in Rotterdam - Erasmus Medisch Centrum toegepast.
- Hoge dosis radioactief jodium - ook wel bekend als inwendige bestraling - als aanvulling gegeven aan patiënten met uitgezaaide carcinoid, waarbij alle andere medicijnen en aanpak niets hielp geeft significant betere resultaten op langere overlevingstijd
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