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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In 32 GEP-NET patients, the first clinical experience on efficacy and safety showed 225Ac-DOTATATE TAT as a promising treatment option for patients who are refractory to 177Lu-DOTATATE therapy.
“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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Demirci, E., Selçuk, N. A., Beydağı, G., Ocak, M., Toklu, T., Akçay, K., & Kabasakal, L. (2023) · Molecular Imaging and Radionuclide Therapy · doi:10.4274/mirt.galenos.2023.38258 · Cited by 28 · see citing works
Wharton, L., McNeil, S., Merkens, H., Yuan, Z., de Voorde, M. V., Engudar, G., Ingham, A., Koniar, H., Rodríguez‐Rodríguez, C., Radchenko, V., et al. (2023) · Molecules · doi:10.3390/molecules28073155 · Cited by 27 · see citing works
“Targeted alpha therapy (TAT) utilising α-emitting radionuclides (225Ac, 227Th, 230U, 213Bi, 211At) is being intensively pursued in the emerging radiopharmaceutical sector as a potential alternative to conventional β-therapy for treatment of systemic malignancies, with several Phase II clinical trials underway ([225Ac]…”
BackgroundRecent advances in the development of 225Ac- and 211At-labeled radioligands for radiotheranostics
Munekane, M., Fuchigami, T., & Ogawa, K. (2024) · Analytical Sciences · doi:10.1007/s44211-024-00514-w · Cited by 25 · see citing works
Ku, E. J., Kim, K. J., Kim, J. H., Kim, M. K., Ahn, C. H., Lee, K. A., Lee, S. H., Lee, Y., Park, K. H., Choi, Y. M., et al. (2021) · Endocrinology and Metabolism · doi:10.3803/enm.2020.908 · Cited by 25 · see citing works
“PRRT as compassionate or off-label use [78,79].”
Ramirez, R. A., Cass, A. S., Das, S., Low, S., Mehrad, M., Rickman, O. B., Scherer, P. M., Thomas, K. E. H., & Gillaspie, E. A. (2022) · Translational Lung Cancer Research · doi:10.21037/tlcr-22-415 · Cited by 25 · see citing works
Towards Effective Targeted Alpha Therapy for Neuroendocrine Tumours: A Review
Gape, P. M. D., Schultz, M. K., Stasiuk, G. J., & Terry, S. Y. A. (2024) · Pharmaceuticals · doi:10.3390/ph17030334 · Cited by 25 · see citing works
“Following this, safety and efficacy will be assessed.”
BackgroundThe Different Strategies for the Radiolabeling of [211At]-Astatinated Radiopharmaceuticals
Gao, J., Li, M., Yin, J., Liu, M., Wang, H., Du, J., & Li, J. (2024) · Pharmaceutics · doi:10.3390/pharmaceutics16060738 · Cited by 23 · see citing works
“For example, 225 Ac-DOTATATE is a promising treatment option that introduces a new dimension in patients who are unresponsive to 177 Lu-DOTATATE therapy or have attained the maximum prescribed cycles of 177 Lu-DOTATATE therapy [8].”
BackgroundApproach to the Patient With Metastatic Pheochromocytoma and Paraganglioma
Alkaissi, H. R., Taïeb, D., Lin, F. I., Rivero, J. D., Wang, K., Clifton-Bligh, R. J., & Pacák, K. (2025) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgaf259 · Cited by 23 · see citing works
Radionuclide-based theranostics — a promising strategy for lung cancer
Zhu, T., Hsu, J. C., Guo, J., Chen, W., Cai, W., & Wang, K. (2023) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-023-06174-8 · Cited by 22 · see citing works
The five “W”s and “How” of Targeted Alpha Therapy: Why? Who? What? Where? When? and How?
Sollini, M., Marzo, K., Chiti, A., & Kirienko, M. (2020) · RENDICONTI LINCEI · doi:10.1007/s12210-020-00900-2 · Cited by 21 · see citing works
“Recently, short-term results of a prospective study recruiting patients with metastatic gastroenteropancreatic neuroendocrine tumors stable or progressive on 177Lu-DOTATATE therapy showed partial response or stable disease (24/32 and 9/32, respectively) in all cases after 225Ac-DOTATATE treatment (100 kBq/ kg body wei…”
BackgroundKamaleshwaran, K., Suneelkumar, M., Madhusairam, R., Radhakrishnan, E. K., Arunpandiyan, S., & Arnold, V. (2020) · Indian Journal of Nuclear Medicine · doi:10.4103/ijnm.ijnm_58_20 · Cited by 21 · see citing works
Castillo, D., Saint‐Hubert, M. D., Ahenkorah, S., Vargas, C. S., Ooms, M., Struelens, L., & Koole, M. J. B. (2022) · EJNMMI Radiopharmacy and Chemistry · doi:10.1186/s41181-022-00174-z · Cited by 20 · see citing works
“and induce radiation related side effects, such that RDE is often assumed to be the main cause of radiotoxicity for the organs at risk (OAR) and one of the main reasons for limiting the amount of activity of 225Ac-labeled radionuclides administered to patients (Ballal et al. 2020; Kratochwil et al. 2017, 2015; Khreish…”
BackgroundHan, G., Hwang, E., Lin, F., Clift, R., Kim, D., Guest, M., Bischoff, E. D., Moran, S. E., & Li, G. (2023) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-23-0029 · Cited by 21 · see citing works
Radionuclide Theranostics in Neuroendocrine Neoplasms: An Update
Franco, M. D., Zanoni, L., Fortunati, E., Fanti, S., & Ambrosini, V. (2024) · Current Oncology Reports · doi:10.1007/s11912-024-01526-5 · Cited by 21 · see citing works
“SST-targeting tracers labeled with alpha emitters [212Pb], [213Bi] [108], and [225Ac] [109] have been developed for their promising characteristics, i.e., higher linear energy transfer and lower tissue penetration (40–100 µm) compared to beta-emitters, allowing to deliver higher cytotoxic radiation…”
BackgroundZaid, N. R. R., Kletting, P., Winter, G., Prasad, V., Beer, A. J., & Glatting, G. (2021) · Pharmaceutics · doi:10.3390/pharmaceutics13122132 · Cited by 20 · see citing works
“Keywords: murine PBPK model; neuroendocrine tumors; α-PRRT; in vivo alpha particle generators; [212Pb]Pb-DOTAMTATE”
BackgroundInfluentialZhang, J., Kulkarni, H. R., & Baum, R. P. (2021) · Clinical Nuclear Medicine · doi:10.1097/rlu.0000000000003792 · Cited by 19 · see citing works
Quality of life in patients with gastroenteropancreatic tumours: A systematic literature review
Watson, C., Tallentire, C. W., Ramage, J. K., Srirajaskanthan, R., Leeuwenkamp, O. R., & Fountain, D. (2020) · World Journal of Gastroenterology · doi:10.3748/wjg.v26.i25.3686 · Cited by 19 · see citing works
Targeted alpha-particle therapy in neuroendocrine neoplasms: A systematic review
Koh, T. T., Bezak, E., Chan, D. L. H., & Cehic, G. (2021) · World Journal of Nuclear Medicine · doi:10.4103/wjnm.wjnm_160_20 · Cited by 18 · see citing works
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Radiopharmaceuticals for Cancer Diagnosis and Therapy
Taunk, N. K., Escorcia, F. E., Lewis, J. S., & Bodei, L. (2024) · The Cancer Journal · doi:10.1097/ppo.0000000000000720 · Cited by 17 · see citing works
Advances in Molecular Imaging and Radionuclide Therapy of Neuroendocrine Tumors
Yordanova, A., Biersack, H., & Ahmadzadehfar, H. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9113679 · Cited by 17 · see citing works
Combination Therapies with PRRT
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Somatostatin receptor radionuclide therapy in neuroendocrine tumors
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Health-related quality of life in neuroendocrine neoplasia: a critical review
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Clinical Pharmacology of Radiotheranostics in Oncology
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Strategies Towards Improving Clinical Outcomes of Peptide Receptor Radionuclide Therapy
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The Role of Artificial Intelligence in Advancing Theranostics Dosimetry for Cancer Therapy: a Review
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Recent Advances in Radiopharmaceutical Theranostics of Pheochromocytoma and Paraganglioma
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“Indeed, SSTR expression in AR42J cells and tumors is known and has been previously studied [31–33], but to our knowledge this is the first time that a comparison of [ 68 Ga] Ga-DOTATOC and [ 18 F]F-FDG by PET/MRI is carried out in a mouse model of NET liver metastases.”
InfluentialIn vivo quantitative SPECT imaging of actinium-226: feasibility and proof-of-concept
Koniar, H., Wharton, L., Ingham, A., Rodríguez‐Rodríguez, C., Kunz, P., Radchenko, V., Yang, H., Rahmim, A., Uribe, C., & Schaffer, P. C. (2024) · Physics in Medicine and Biology · doi:10.1088/1361-6560/ad5c37 · Cited by 11 · see citing works
Emerging Therapeutic Radiopharmaceuticals and Their Theranostic Pairs
Carbo‐Bague, I., & Ramogida, C. F. (2021) · Wiley eBooks · doi:10.1002/9781119951438.eibc2763 · Cited by 12 · see citing works
Astatine-211 and actinium-225: two promising nuclides in targeted alpha therapy
Zuo, D., Wang, H. Z., Yu, B., Li, H., Gan, L., & Chen, W. (2024) · Acta Biochimica et Biophysica Sinica · doi:10.3724/abbs.2024206 · Cited by 9 · see citing works
- 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 › Epidemiology › Neuroendocrine Tumor Research Advances
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Health Sciences › Medicine › Oncology › 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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