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Efficacy and safety of (177)Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study

PURPOSE: NETTER-R aimed to determine the efficacy, safety and tolerability of (177)Lu-DOTATATE in patients with progressive, advanced pancreatic neuroendocrine tumours (panNETs) using retrospective real-world data from multiple sites. METHODS: This international study retrospectively included patien...

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Autores principales: Clement, Dominique, Navalkissoor, Shaunak, Srirajaskanthan, Rajaventhan, Courbon, Frédéric, Dierickx, Lawrence, Eccles, Amy, Lewington, Valerie, Mitjavila, Mercedes, Percovich, Juan Carlos, Lequoy, Benoît, He, Beilei, Folitar, Ilya, Ramage, John
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9308585/
https://www.ncbi.nlm.nih.gov/pubmed/35389069
http://dx.doi.org/10.1007/s00259-022-05771-3
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author Clement, Dominique
Navalkissoor, Shaunak
Srirajaskanthan, Rajaventhan
Courbon, Frédéric
Dierickx, Lawrence
Eccles, Amy
Lewington, Valerie
Mitjavila, Mercedes
Percovich, Juan Carlos
Lequoy, Benoît
He, Beilei
Folitar, Ilya
Ramage, John
author_facet Clement, Dominique
Navalkissoor, Shaunak
Srirajaskanthan, Rajaventhan
Courbon, Frédéric
Dierickx, Lawrence
Eccles, Amy
Lewington, Valerie
Mitjavila, Mercedes
Percovich, Juan Carlos
Lequoy, Benoît
He, Beilei
Folitar, Ilya
Ramage, John
author_sort Clement, Dominique
collection PubMed
description PURPOSE: NETTER-R aimed to determine the efficacy, safety and tolerability of (177)Lu-DOTATATE in patients with progressive, advanced pancreatic neuroendocrine tumours (panNETs) using retrospective real-world data from multiple sites. METHODS: This international study retrospectively included patients with panNETs treated with (177)Lu-DOTATATE. The primary endpoint was progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints included overall survival (OS), safety and tumour response. RESULTS: In total, 110 patients with panNETs were studied; 65.5% received a cumulative dose of (177)Lu-DOTATATE 29.6 GBq ± 10% (median: 7.4 GBq). In 62 patients with available RECIST v1.1 tumour response, the median PFS was 24.8 months (95% confidence interval [CI]: 17.5–34.5), and the objective response rate was 40.3% (95% CI: 28.1–53.6); all responses were partial. With a median follow up of 24.5 months (range: 2.0–123.4 months) after the first cycle of (177)Lu-DOTATATE, the median OS in the full analysis set (n = 110) was 41.4 months (95% CI: 28.6–50.2). PFS (hazard ratio [HR]: 3.672; p = 0.0009) and OS (HR: 3.360; p < 0.0001) were longer in patients who received no chemotherapy prior to (177)Lu-DOTATATE than those who did. No treatment-emergent adverse events (TEAEs) led to treatment discontinuation. Grade 3 anaemia, lymphopenia and thrombocytopenia occurred in 0.9%, 5.4% and 0.9% of patients, respectively. No acute leukaemia or myelodysplastic syndrome was reported. Six patients (5.5%) had renal TEAEs. All renal grade ≥ 3 events were transient and did not lead to treatment modification. CONCLUSIONS: These results reinforce the role of (177)Lu-DOTATATE for the treatment of patients with advanced, somatostatin receptor-positive panNETs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00259-022-05771-3.
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spelling pubmed-93085852022-07-25 Efficacy and safety of (177)Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study Clement, Dominique Navalkissoor, Shaunak Srirajaskanthan, Rajaventhan Courbon, Frédéric Dierickx, Lawrence Eccles, Amy Lewington, Valerie Mitjavila, Mercedes Percovich, Juan Carlos Lequoy, Benoît He, Beilei Folitar, Ilya Ramage, John Eur J Nucl Med Mol Imaging Original Article PURPOSE: NETTER-R aimed to determine the efficacy, safety and tolerability of (177)Lu-DOTATATE in patients with progressive, advanced pancreatic neuroendocrine tumours (panNETs) using retrospective real-world data from multiple sites. METHODS: This international study retrospectively included patients with panNETs treated with (177)Lu-DOTATATE. The primary endpoint was progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints included overall survival (OS), safety and tumour response. RESULTS: In total, 110 patients with panNETs were studied; 65.5% received a cumulative dose of (177)Lu-DOTATATE 29.6 GBq ± 10% (median: 7.4 GBq). In 62 patients with available RECIST v1.1 tumour response, the median PFS was 24.8 months (95% confidence interval [CI]: 17.5–34.5), and the objective response rate was 40.3% (95% CI: 28.1–53.6); all responses were partial. With a median follow up of 24.5 months (range: 2.0–123.4 months) after the first cycle of (177)Lu-DOTATATE, the median OS in the full analysis set (n = 110) was 41.4 months (95% CI: 28.6–50.2). PFS (hazard ratio [HR]: 3.672; p = 0.0009) and OS (HR: 3.360; p < 0.0001) were longer in patients who received no chemotherapy prior to (177)Lu-DOTATATE than those who did. No treatment-emergent adverse events (TEAEs) led to treatment discontinuation. Grade 3 anaemia, lymphopenia and thrombocytopenia occurred in 0.9%, 5.4% and 0.9% of patients, respectively. No acute leukaemia or myelodysplastic syndrome was reported. Six patients (5.5%) had renal TEAEs. All renal grade ≥ 3 events were transient and did not lead to treatment modification. CONCLUSIONS: These results reinforce the role of (177)Lu-DOTATATE for the treatment of patients with advanced, somatostatin receptor-positive panNETs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00259-022-05771-3. Springer Berlin Heidelberg 2022-04-07 2022 /pmc/articles/PMC9308585/ /pubmed/35389069 http://dx.doi.org/10.1007/s00259-022-05771-3 Text en © The Author(s) 2022 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
Clement, Dominique
Navalkissoor, Shaunak
Srirajaskanthan, Rajaventhan
Courbon, Frédéric
Dierickx, Lawrence
Eccles, Amy
Lewington, Valerie
Mitjavila, Mercedes
Percovich, Juan Carlos
Lequoy, Benoît
He, Beilei
Folitar, Ilya
Ramage, John
Efficacy and safety of (177)Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study
title Efficacy and safety of (177)Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study
title_full Efficacy and safety of (177)Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study
title_fullStr Efficacy and safety of (177)Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study
title_full_unstemmed Efficacy and safety of (177)Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study
title_short Efficacy and safety of (177)Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study
title_sort efficacy and safety of (177)lu‑dotatate in patients with advanced pancreatic neuroendocrine tumours: data from the netter-r international, retrospective study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9308585/
https://www.ncbi.nlm.nih.gov/pubmed/35389069
http://dx.doi.org/10.1007/s00259-022-05771-3
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