Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study
Mercedes Mitjavila 1 , Paula Jimenez-Fonseca 2 , Pilar Belló 3 , Virginia Pubul 4 , Juan Carlos Percovich 5 , Amparo Garcia-Burillo 6 , Jorge Hernando 7 , Javier Arbizu 8 , Emilia Rodeño 9 , Montserrat Estorch 10 , Belén Llana 11 , Maribel Castellón 12 , Lina García-Cañamaque 13 , Pablo Gajate 14 , Maria Carmen Riesco 15 , Maria Begoña Miguel 16 , David Balaguer-Muñoz 17 , Ana Custodio 18 , Juana María Cano 19 , Alexandra Repetto 20 , Pilar Garcia-Alonso 21 , Maria Angustias Muros 22 , Jose Luis Vercher-Conejero 23 , Alberto Carmona-Bayonas 24
Background: Peptide receptor radionuclide therapy (PRRT) is one of the most promising therapeutic strategies in neuroendocrine neoplasms (NENs). Nevertheless, its role in certain tumor sites remains unclear.
This study sought to elucidate the efficacy and safety of [177Lu]Lu-DOTATATE in NENs with different locations and evaluate the effect of the tumor origin, bearing in mind other prognostic variables.
Advanced NENs overexpressing somatostatin receptors (SSTRs) on functional imaging, of any grade or location, treated at 24 centers were enrolled. The protocol consisted of four cycles of 177Lu-DOTATATE 7.4 GBq iv every 8 weeks (NCT04949282).
Results: The sample comprised 522 subjects with pancreatic (35%), midgut (28%), bronchopulmonary (11%), pheochromocytoma/ paraganglioma (PPGL) (6%), other gastroenteropancreatic (GEP) (11%), and other non-gastroenteropancreatic (NGEP) (9%) NENs. The best RECIST 1.1 responses were complete response, 0.7%; partial response, 33.2%; stable disease, 52.1%; and tumor progression, 14%, with activity conditioned by the tumor subtype, but with benefit in all strata.
Median progression-free survival (PFS) was 31.3 months (95% CI, 25.7-not reached [NR]) in midgut, 30.6 months (14.4-NR) in PPGL, 24.3 months (18.0-NR) in other GEP, 20.5 months (11.8-NR) in other NGEP, 19.8 months (16.8-28.1) in pancreatic, and 17.6 months (14.4-33.1) in bronchopulmonary NENs. [177Lu]Lu-DOTATATE exhibited scant severe toxicity.
Conclusion: This study confirms the efficacy and safety of [177Lu]Lu-DOTATATE in a wide range of SSTR-expressing NENs, regardless of location, with clinical benefit and superimposable survival outcomes between pNENs and other GEP and NGEP tumor subtypes different from midgut NENs.
CITA DEL ARTÍCULO Eur J Nucl Med Mol Imaging. 2023 Mar 6. doi: 10.1007/s00259-023-06166-8