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Efficacy of [(177)Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study

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 [(177)Lu]Lu-DOTATATE in NENs with...

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Autores principales: Mitjavila, Mercedes, Jimenez-Fonseca, Paula, Belló, Pilar, Pubul, Virginia, Percovich, Juan Carlos, Garcia-Burillo, Amparo, Hernando, Jorge, Arbizu, Javier, Rodeño, Emilia, Estorch, Montserrat, Llana, Belén, Castellón, Maribel, García-Cañamaque, Lina, Gajate, Pablo, Riesco, Maria Carmen, Miguel, Maria Begoña, Balaguer-Muñoz, David, Custodio, Ana, Cano, Juana María, Repetto, Alexandra, Garcia-Alonso, Pilar, Muros, Maria Angustias, Vercher-Conejero, Jose Luis, Carmona-Bayonas, Alberto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10250456/
https://www.ncbi.nlm.nih.gov/pubmed/36877234
http://dx.doi.org/10.1007/s00259-023-06166-8
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author Mitjavila, Mercedes
Jimenez-Fonseca, Paula
Belló, Pilar
Pubul, Virginia
Percovich, Juan Carlos
Garcia-Burillo, Amparo
Hernando, Jorge
Arbizu, Javier
Rodeño, Emilia
Estorch, Montserrat
Llana, Belén
Castellón, Maribel
García-Cañamaque, Lina
Gajate, Pablo
Riesco, Maria Carmen
Miguel, Maria Begoña
Balaguer-Muñoz, David
Custodio, Ana
Cano, Juana María
Repetto, Alexandra
Garcia-Alonso, Pilar
Muros, Maria Angustias
Vercher-Conejero, Jose Luis
Carmona-Bayonas, Alberto
author_facet Mitjavila, Mercedes
Jimenez-Fonseca, Paula
Belló, Pilar
Pubul, Virginia
Percovich, Juan Carlos
Garcia-Burillo, Amparo
Hernando, Jorge
Arbizu, Javier
Rodeño, Emilia
Estorch, Montserrat
Llana, Belén
Castellón, Maribel
García-Cañamaque, Lina
Gajate, Pablo
Riesco, Maria Carmen
Miguel, Maria Begoña
Balaguer-Muñoz, David
Custodio, Ana
Cano, Juana María
Repetto, Alexandra
Garcia-Alonso, Pilar
Muros, Maria Angustias
Vercher-Conejero, Jose Luis
Carmona-Bayonas, Alberto
author_sort Mitjavila, Mercedes
collection PubMed
description 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 [(177)Lu]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 (177)Lu-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. [(177)Lu]Lu-DOTATATE exhibited scant severe toxicity. CONCLUSION: This study confirms the efficacy and safety of [(177)Lu]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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00259-023-06166-8.
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spelling pubmed-102504562023-06-10 Efficacy of [(177)Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study Mitjavila, Mercedes Jimenez-Fonseca, Paula Belló, Pilar Pubul, Virginia Percovich, Juan Carlos Garcia-Burillo, Amparo Hernando, Jorge Arbizu, Javier Rodeño, Emilia Estorch, Montserrat Llana, Belén Castellón, Maribel García-Cañamaque, Lina Gajate, Pablo Riesco, Maria Carmen Miguel, Maria Begoña Balaguer-Muñoz, David Custodio, Ana Cano, Juana María Repetto, Alexandra Garcia-Alonso, Pilar Muros, Maria Angustias Vercher-Conejero, Jose Luis Carmona-Bayonas, Alberto Eur J Nucl Med Mol Imaging Original Article 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 [(177)Lu]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 (177)Lu-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. [(177)Lu]Lu-DOTATATE exhibited scant severe toxicity. CONCLUSION: This study confirms the efficacy and safety of [(177)Lu]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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00259-023-06166-8. Springer Berlin Heidelberg 2023-03-06 2023 /pmc/articles/PMC10250456/ /pubmed/36877234 http://dx.doi.org/10.1007/s00259-023-06166-8 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Mitjavila, Mercedes
Jimenez-Fonseca, Paula
Belló, Pilar
Pubul, Virginia
Percovich, Juan Carlos
Garcia-Burillo, Amparo
Hernando, Jorge
Arbizu, Javier
Rodeño, Emilia
Estorch, Montserrat
Llana, Belén
Castellón, Maribel
García-Cañamaque, Lina
Gajate, Pablo
Riesco, Maria Carmen
Miguel, Maria Begoña
Balaguer-Muñoz, David
Custodio, Ana
Cano, Juana María
Repetto, Alexandra
Garcia-Alonso, Pilar
Muros, Maria Angustias
Vercher-Conejero, Jose Luis
Carmona-Bayonas, Alberto
Efficacy of [(177)Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study
title Efficacy of [(177)Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study
title_full Efficacy of [(177)Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study
title_fullStr Efficacy of [(177)Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study
title_full_unstemmed Efficacy of [(177)Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study
title_short Efficacy of [(177)Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study
title_sort efficacy of [(177)lu]lu-dotatate in metastatic neuroendocrine neoplasms of different locations: data from the septralu study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10250456/
https://www.ncbi.nlm.nih.gov/pubmed/36877234
http://dx.doi.org/10.1007/s00259-023-06166-8
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