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Broadening horizons with 225Ac-DOTATATE targeted alpha therapy for gastroenteropancreatic neuroendocrine tumour patients stable or refractory to 177Lu-DOTATATE PRRT: first clinical experience on the efficacy and safety
Abstract
Purpose The objective of this study was to investigate and present the early results on the efficacy, safety, and quality of life of 225 Ac-DOTATATE targeted alpha therapy (TAT) in patients with advanced, progressive, 177 Lu-DOTATATE refractory, and somatostatin receptor (SSTR) expressing metastatic GEP-NETs.Methods In this prospective study, we recruited patients with metastatic GEP-NETs who were stable or progressive disease on 177 Lu-DOTATATE therapy. Systemic TAT using 225 Ac-DOTATATE was performed in all the patients with 225 Ac-DOTATATE (100 kBq/kg body weight) at an interval of 8 weeks. The primary end point was to assess the objective response (measured by RECIST 1.1 and functional M.D. Anderson criteria). The secondary end points included biochemical response assessment as per the Italian Trials in Medical Oncology (ITMO), adverse event profile as per CTCAE v5.0, and clinical response assessment by the quality of life (assessed with EORTC QLQ-GI.NET21 patient-based questionnaire).Results Between April 2018 and March 2019, 32 patients (17 females, 15 males, mean age 52 ± 9.2 years, 35-72 years) with either stable disease after completing 177 Lu-DOTATATE therapy (14, 44%) or progressive disease on 177 Lu-DOTATATE therapy (18, 56%) were included in the study. The morphological response was assessed in 24/32 patients that revealed partial remission in 15 and stable disease in 9. There was no documented disease progression or deaths in the median follow-up of 8 months (range 2-13 months). There was a significant decrease in the plasma chromogranin level post-225 Ac-DOTATATE therapy (P < 0.0001).Conclusion Our short-term clinical results indicate 225 Ac-DOTATATE TAT as a promising treatment option which adds a new dimension in patients who are refractory to 177 Lu-DOTATATE therapy or have reached the maximum prescribed cycles of 177 Lu-DOTATATE therapy.
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“First clinical experience on efficacy and safety225Ac-DOTATATE TAT as a promising treatment option for patients who are refractory to 177Lu-DOTATATE therapy”
From Alpha-peptide receptor radionuclide therapy using actinium-225 labeled somatostatin receptor agonists and antagonists (2022) · cites this paper as [159]
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Metadata
- Authors
- Ballal, S., Yadav, M. P., Bal, C., Sahoo, R. K., & Tripathi, M.
- Affiliations
- All India Institute of Medical Sciences (IN)
- DR. B.R.A. Institute Rotary Cancer Hospital (IN)
- Corresponding author
- Bal, Chandrasekhar
- Venue
- European Journal of Nuclear Medicine and Molecular Imaging
- Published
- 2019-11-10
- Volume
- 47
- Issue
- 4
- Pages
- 934-946
- ISSN
- 1619-7070 (ISSN-L)
- 1619-7089
- OpenAlex
- W2984721232
- Cited by
- 215
- References
- 23
- Citations by year
- 2026: 24 · 2025: 42 · 2024: 31 · 2023: 34 · 2022: 36 · 2021: 34 · 2020: 14
- FWCI
- 15.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Nuclear Medicine and Molecular Imaging (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Neuroendocrine Tumor Research Advances
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Peptidase Inhibition and Analysis
- Keywords
- targeted alpha therapy, gastroenteropancreatic neuroendocrine tumors, 177Lu-DOTATATE, peptide receptor radionuclide therapy, somatostatin receptors, refractory disease, progressive disease, objective response, quality of life, chromogranin A, treatment safety, adverse events, metastatic neuroendocrine tumors
- MeSH terms
- Adult, Aged, Female, Humans, Intestinal Neoplasms, Male, Middle Aged, Organometallic Compounds, Pancreatic Neoplasms, Prospective Studies, Quality of Life, Stomach Neoplasms, Octreotide, Neuroendocrine Tumors
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