A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours
© 2023. The Author(s)..
PURPOSE: We present the results of an open-label, phase I/II study evaluating the safety and efficacy of the novel somatostatin receptor (SSTR) antagonist [177Lu]Lu-satoreotide tetraxetan in 40 patients with previously treated, progressive neuroendocrine tumours (NETs), in which dosimetry was used to guide maximum administered activity.
METHODS: This study was conducted in two parts. Part A consisted of 15 patients who completed three cycles of [177Lu]Lu-satoreotide tetraxetan at a fixed administered activity and peptide amount per cycle (4.5 GBq/300 µg). Part B, which included 25 patients who received one to five cycles of [177Lu]Lu-satoreotide tetraxetan, evaluated different administered activities (4.5 or 6.0 GBq/cycle) and peptide amounts (300, 700, or 1300 μg/cycle), limited to a cumulative absorbed radiation dose of 23 Gy to the kidneys and 1.5 Gy to the bone marrow.
RESULTS: Median cumulative administered activity of [177Lu]Lu-satoreotide tetraxetan was 13.0 GBq over three cycles (13.1 GBq in part A and 12.9 GBq in part B). Overall, 17 (42.5%) patients experienced grade ≥ 3 treatment‑related adverse events; the most common were lymphopenia, thrombocytopenia, and neutropenia. No grade 3/4 nephrotoxicity was observed. Two patients developed myeloid neoplasms considered treatment related by the investigator. Disease control rate for part A and part B was 94.7% (95% confidence interval [CI]: 82.3-99.4), and overall response rate was 21.1% (95% CI: 9.6-37.3).
CONCLUSION: [177Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT02592707. Registered October 30, 2015.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:51 |
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| Enthalten in: |
European journal of nuclear medicine and molecular imaging - 51(2023), 1 vom: 29. Dez., Seite 183-195 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wild, Damian [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 29.11.2023 Date Revised 01.01.2024 published: Print-Electronic ClinicalTrials.gov: NCT02592707 Citation Status MEDLINE |
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| doi: |
10.1007/s00259-023-06383-1 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM362184275 |
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| 100 | 1 | |a Wild, Damian |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 29.11.2023 | ||
| 500 | |a Date Revised 01.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02592707 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a PURPOSE: We present the results of an open-label, phase I/II study evaluating the safety and efficacy of the novel somatostatin receptor (SSTR) antagonist [177Lu]Lu-satoreotide tetraxetan in 40 patients with previously treated, progressive neuroendocrine tumours (NETs), in which dosimetry was used to guide maximum administered activity | ||
| 520 | |a METHODS: This study was conducted in two parts. Part A consisted of 15 patients who completed three cycles of [177Lu]Lu-satoreotide tetraxetan at a fixed administered activity and peptide amount per cycle (4.5 GBq/300 µg). Part B, which included 25 patients who received one to five cycles of [177Lu]Lu-satoreotide tetraxetan, evaluated different administered activities (4.5 or 6.0 GBq/cycle) and peptide amounts (300, 700, or 1300 μg/cycle), limited to a cumulative absorbed radiation dose of 23 Gy to the kidneys and 1.5 Gy to the bone marrow | ||
| 520 | |a RESULTS: Median cumulative administered activity of [177Lu]Lu-satoreotide tetraxetan was 13.0 GBq over three cycles (13.1 GBq in part A and 12.9 GBq in part B). Overall, 17 (42.5%) patients experienced grade ≥ 3 treatment‑related adverse events; the most common were lymphopenia, thrombocytopenia, and neutropenia. No grade 3/4 nephrotoxicity was observed. Two patients developed myeloid neoplasms considered treatment related by the investigator. Disease control rate for part A and part B was 94.7% (95% confidence interval [CI]: 82.3-99.4), and overall response rate was 21.1% (95% CI: 9.6-37.3) | ||
| 520 | |a CONCLUSION: [177Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov, NCT02592707. Registered October 30, 2015 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Clinical Trial, Phase I | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Neuroendocrine tumours | |
| 650 | 4 | |a Peptide receptor radionuclide therapy | |
| 650 | 4 | |a Somatostatin receptor antagonist | |
| 650 | 4 | |a [177Lu]Lu-satoreotide tetraxetan | |
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| 700 | 1 | |a Navalkissoor, Shaunak |e verfasserin |4 aut | |
| 700 | 1 | |a Haug, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Nicolas, Guillaume P |e verfasserin |4 aut | |
| 700 | 1 | |a Pais, Ben |e verfasserin |4 aut | |
| 700 | 1 | |a Ansquer, Catherine |e verfasserin |4 aut | |
| 700 | 1 | |a Beauregard, Jean-Mathieu |e verfasserin |4 aut | |
| 700 | 1 | |a McEwan, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Lassmann, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Pennestri, Daniele |e verfasserin |4 aut | |
| 700 | 1 | |a Volteau, Magali |e verfasserin |4 aut | |
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