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Phase I Trial of Well-Differentiated Neuroendocrine Tumors (NETs) with Radiolabeled Somatostatin Antagonist 177Lu-Satoreotide Tetraxetan.
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Abstract
Abstract Purpose: Radiolabeled somatostatin receptor 2 (SSTR2) antagonists have shown higher tumor uptake and tumor-to-organ ratios than somatostatin agonists in preclinical models of neuroendocrine tumors (NETs). We performed a phase I study to evaluate the safety and efficacy of SSTR2 antagonist 177Lu-satoreotide tetraxetan. Patients and Methods: Twenty patients with advanced SSTR2-positive NETs were treated with 177Lu-satoreotide tetraxetan. Patients first underwent a dosimetry study with 177Lu-satoreotide tetraxetan to determine the therapeutic activity that could be safely administered. This activity was split into two equal cycles to be delivered 3 months apart. The maximum activity was 7.4 GBq per cycle. Results: Of 20 patients with NETs (one lung, seven small bowel, nine pancreatic, one gastric, one rectal, one kidney; mean prior treatments: three), six received one cycle of 177Lu- satoreotide tetraxetan and 14 received two cycles. Hematologic toxicity after cycle 1 was mild-moderate and reversed before cycle 2. However, grade 4 hematologic toxicity occurred in four of seven (57%) patients after cycle 2 of 177Lu-satoreotide tetraxetan. The study was suspended, and the protocol modified to limit the cumulative absorbed bone marrow dose to 1 Gy and to reduce prescribed activity for cycle 2 by 50%. The best overall response rate was 45% [5% complete response (1/20), 40% partial response (8/20)]; with 40% stable disease (8/20) and 15% progression of disease (3/20). Median progression-free survival (PFS) was 21.0 months (95% CI, 13.6–NR). Conclusions: In this trial of heavily treated NETs, preliminary data are promising for the use of 177Lu-satoreotide tetraxetan. Additional studies are ongoing to determine optimal therapeutic dose/schedule.
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“Unfortunately, grade 4 hematotoxicity was reported in 4 out of 7 patients after two cycles of 177Lu-DOTA-JR11, resulting in the suspension of this therapy protocol (138).”
From Alpha-peptide receptor radionuclide therapy using actinium-225 labeled somatostatin receptor agonists and antagonists (2022) · cites this paper as [138]
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Metadata
- Authors
- Reidy-Lagunes, D., Pandit-Taskar, N., O'Donoghue, J. A., Krebs, S., Staton, K. D., Lyashchenko, S. K., Lewis, J. S., Raj, N., Gönen, M., Lohrmann, C., Bodei, L., & Weber, W. A.
- Affiliations
- 1Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
- Memorial Sloan Kettering Cancer Center (US)
- 3Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York.
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2019-12-01
- Volume
- 25
- Issue
- 23
- Pages
- 6939-6947
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC8382090
- OpenAlex
- W2969596297
- Cited by
- 112
- References
- 34
- Citations by year
- 2026: 17 · 2025: 14 · 2024: 15 · 2023: 16 · 2022: 23 · 2021: 14 · 2020: 11 · 2019: 2
- FWCI
- 9.52
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- NIH NCI (P30 CA008748, K12 CA184746)
- Topics
- Health Sciences › Medicine › Oncology › Neuroendocrine Tumor Research Advances
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Medical Imaging Techniques and Applications
- Keywords
- well-differentiated neuroendocrine tumors, radiolabeled somatostatin analogs, peptide receptor radionuclide therapy, dosimetry, hematologic toxicity, bone marrow dose, progression-free survival, treatment efficacy and safety
- MeSH terms
- Adult, Aged, Chelating Agents, Female, Follow-Up Studies, Heterocyclic Compounds, 1-Ring, Humans, Lutetium, Male, Middle Aged, Neoplasm Metastasis, Prognosis, Radioisotopes, Octreotide, Receptors, Somatostatin, Neuroendocrine Tumors, Radiopharmaceuticals, Young Adult
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