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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

Ballal, Sanjana, Yadav, Madhav Prasad, Bal, Chandrasekhar, Sahoo, Ranjit Kumar, Tripathi, Madhavi·2020·European Journal of Nuclear Medicine and Molecular Imaging

DOI 10.1007/s00259-019-04567-2

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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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“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]…”
Background
Recent 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
Diagnosis for Pheochromocytoma and Paraganglioma: A Joint Position Statement of the Korean Pheochromocytoma and Paraganglioma Task Force
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
“PRRT as compassionate or off-label use [78,79].”
A multidisciplinary approach to the work up and management of pulmonary carcinoid tumors and DIPNECH: a narrative review
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 27
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 26
“Following this, safety and efficacy will be assessed.”
Background
The 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
“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].”
Background
Approach 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 24
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
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
“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…”
Background
Whole-body and single-photon emission computed tomography/computed tomography postpeptide receptor alpha radionuclide therapy images of actinium 225-tetraazacyclododecanetetraacetic Acid–Octreotide as a primary modality of treatment in a patient with advanced rectal neuroendocrine tumor with metastases
Kamaleshwaran, 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
Gamma counting protocols for the accurate quantification of 225Ac and 213Bi without the need for a secular equilibrium between parent and gamma-emitting daughter
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
“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…”
Background
RYZ101 (Ac-225 DOTATATE) Opportunity beyond Gastroenteropancreatic Neuroendocrine Tumors: Preclinical Efficacy in Small-Cell Lung Cancer
Han, 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 24
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
“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…”
Background
A Physiologically Based Pharmacokinetic Model for In Vivo Alpha Particle Generators Targeting Neuroendocrine Tumors in Mice
Zaid, N. R. R., Kletting, P., Winter, G., Prasad, V., Beer, A. J., & Glatting, G. (2021) · Pharmaceutics · doi:10.3390/pharmaceutics13122132 · Cited by 20
“Keywords: murine PBPK model; neuroendocrine tumors; α-PRRT; in vivo alpha particle generators; [212Pb]Pb-DOTAMTATE”
BackgroundInfluential
225Ac-DOTATOC-Targeted Somatostatin Receptor α-Therapy in a Patient With Metastatic Neuroendocrine Tumor of the Thymus, Refractory to β-Radiation.
Zhang, J., Kulkarni, H. R., & Baum, R. P. (2021) · Clinical Nuclear Medicine · doi:10.1097/rlu.0000000000003792 · Cited by 19
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
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
Preclinical evaluation of [225Ac]Ac-crown-TATE – An alpha-emitting radiopharmaceutical for neuroendocrine tumors
Ingham, A., Wharton, L., Koniar, H., Merkens, H., McNeil, S., Sekar, S., Osooly, M., Rodríguez‐Rodríguez, C., Bénard, F., Schaffer, P. C., et al. (2024) · Nuclear Medicine and Biology · doi:10.1016/j.nucmedbio.2024.108944 · Cited by 18
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 21
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
Combination Therapies with PRRT
Yordanova, A., & Ahmadzadehfar, H. (2021) · Pharmaceuticals · doi:10.3390/ph14101005 · Cited by 17
Peptide receptor radionuclide therapy in neuroendocrine neoplasms and related tumors: from fundamentals to personalization and the newer experimental approaches
Loharkar, S., & Basu, S. (2023) · Expert Review of Precision Medicine and Drug Development · doi:10.1080/23808993.2023.2211090 · Cited by 16
Peptide receptor radionuclide therapy in advanced Pheochromocytomas and Paragangliomas: a systematic review and meta-analysis
Su, D., Yang, H., Chen, Q., & Chen, Y. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1141648 · Cited by 16
Preclinical investigation of [149Tb]Tb-DOTATATE and [149Tb]Tb-DOTA-LM3 for tumor-targeted alpha therapy
Mapanao, A. K., Busslinger, S. D., Mehta, A., Kegler, K., Favaretto, C., Grundler, P. V., Talip, Z., Köster, U., Johnston, K., Schibli, R., et al. (2025) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-024-07035-8 · Cited by 16
Somatostatin receptor radionuclide therapy in neuroendocrine tumors
Haider, M., Das, S., Al‐Toubah, T., Pellè, E., El-Haddad, G. E., & Strosberg, J. (2021) · Endocrine Related Cancer · doi:10.1530/erc-20-0360 · Cited by 16
Health-related quality of life in neuroendocrine neoplasia: a critical review
White, B. E., Druce, M. R., Grozinsky‐Glasberg, S., Srirajaskanthan, R., Gamper, E., Gray, D., Mújica-Mota, R., & Ramage, J. K. (2020) · Endocrine Related Cancer · doi:10.1530/erc-20-0066 · Cited by 16
Targeted alpha therapy: a critical review of translational dosimetry research with emphasis on actinium-225
Castillo, D., Saint‐Hubert, M. D., Crabbé, M., Struelens, L., & Koole, M. J. B. (2020) · The Quarterly Journal of Nuclear Medicine and Molecular Imaging · doi:10.23736/s1824-4785.20.03266-5 · Cited by 15
Clinical Pharmacology of Radiotheranostics in Oncology
Beek, E. T. T., Burggraaf, J., Teunissen, J. J. M., & Vriens, D. (2022) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.2598 · Cited by 16
Strategies Towards Improving Clinical Outcomes of Peptide Receptor Radionuclide Therapy
Minczeles, N. S., Hofland, J., de Herder, W. W., & Brabander, T. (2021) · Current Oncology Reports · doi:10.1007/s11912-021-01037-7 · Cited by 15
Alpha Before Beta: Exceptional Response to First-Line 225Ac-DOTATATE in a Patient of Metastatic Neuroendocrine Tumor With Extensive Skeletal Involvement.
Satapathy, S., Sood, A., Das, C. K., Kavanal, A. J., & Mittal, B. R. (2022) · Clinical Nuclear Medicine · doi:10.1097/rlu.0000000000003823 · Cited by 14
Comparison of Radionuclide Drug Conjugates With Boron Neutron Capture Therapy: An Overview of Targeted Charged Particle Radiation Therapy
Zhang, Y., Coghi, P. S., Ren, Z., Hosmane, N. S., & Zhu, Y. (2024) · Medicinal Research Reviews · doi:10.1002/med.22093 · Cited by 16
The Role of Artificial Intelligence in Advancing Theranostics Dosimetry for Cancer Therapy: a Review
Woo, S. (2025) · Nuclear Medicine and Molecular Imaging · doi:10.1007/s13139-025-00939-9 · Cited by 14
Recent Advances in Radiopharmaceutical Theranostics of Pheochromocytoma and Paraganglioma
Zhang, X., Wakabayashi, H., Hiromasa, T., Kayano, D., & Kinuya, S. (2023) · Seminars in Nuclear Medicine · doi:10.1053/j.semnuclmed.2022.12.005 · Cited by 15
177Lu-labeled somatostatin receptor targeted radionuclide therapy dosimetry in meningioma: a systematic review
Boursier, C., Zaragori, T., Imbert, L., & Verger, A. (2024) · The Quarterly Journal of Nuclear Medicine and Molecular Imaging · doi:10.23736/s1824-4785.24.03571-4 · Cited by 14
Clinical Experience with Targeted Alpha-Emitter Peptide Receptor Radionuclide Therapy (α-PRRT) for Somatostatin Receptor-Positive Neuroendocrine Tumors
Leupe, H., Cauwenbergh, M., Cleeren, F., Dekervel, J., Verslype, C., & Deroose, C. M. (2025) · Pharmaceuticals · doi:10.3390/ph18111608 · Cited by 14
Efficacy and Safety of 225Ac-DOTATATE in the Treatment of Neuroendocrine Neoplasms With High SSTR Expression
Yang, H., Zhang, Y., Li, H., Feng, Y., Yang, X.-Q., & Chen, Y. (2024) · Clinical Nuclear Medicine · doi:10.1097/rlu.0000000000005149 · Cited by 15
Decoding Pancreatic Neuroendocrine Tumors: Molecular Profiles, Biomarkers, and Pathways to Personalized Therapy
Galasso, L., Vitale, F., Giansanti, G., Esposto, G., Borriello, R., Mignini, I., Nicoletti, A., Verme, L. Z. D., Gasbarrini, A., Ainora, M. E., et al. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26167814 · Cited by 13
Advances With 225Ac-DOTATATE Targeted Alpha Therapy in Somatostatin Receptor Positive Neuroendocrine Tumors
Chandekar, K. R., & Bal, C. S. (2025) · Seminars in Nuclear Medicine · doi:10.1053/j.semnuclmed.2025.06.008 · Cited by 14
Subclinical Hypothyroidism After 225Ac-DOTATATE Therapy in a Case of Metastatic Neuroendocrine Tumor: Unknown Adverse Effect of PRRT
Kavanal, A. J., Satapathy, S., Sood, A., Khosla, D., & Mittal, B. R. (2022) · Clinical Nuclear Medicine · doi:10.1097/rlu.0000000000003893 · Cited by 11
Current status and future of targeted peptide receptor radionuclide positron emission tomography imaging and therapy of gastroenteropancreatic-neuroendocrine tumors
Grey, N., Silosky, M. S., Lieu, C. H., & Chin, B. B. (2022) · World Journal of Gastroenterology · doi:10.3748/wjg.v28.i17.1768 · Cited by 12
Development of [225Ac]Ac-DOTA-C595 as radioimmunotherapy of pancreatic cancer: in vitro evaluation, dosimetric assessment and detector calibration
Hull, A., Hsieh, W., Borysenko, A., Tieu, W., Bartholomeusz, D. L., & Bezak, E. (2023) · EJNMMI Radiopharmacy and Chemistry · doi:10.1186/s41181-023-00209-z · Cited by 11
Survival impact of [225Ac]Ac-DOTATOC alpha-therapy in a preclinical model of pancreatic neuroendocrine tumor liver micrometastases
Lugat, A., Chouin, N., Chocteau, F., Esnault, M., Marionneau‐Lambot, S., Gouard, S., Frampas, É., Faivre-Chauvet, A., Bourgeois, M., Morgenstern, A., et al. (2024) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-024-06918-0 · Cited by 11
“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.”
Influential
In 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
Emerging Therapeutic Radiopharmaceuticals and Their Theranostic Pairs
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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 10

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
ORCID: Bal, Chandrasekhar
Sahoo, Ranjit Kumar
Tripathi, Madhavi
Venue: European Journal of Nuclear Medicine and Molecular Imaging
Publisher: Springer Science and Business Media LLC
Published: 2019-11-10
Volume: 47
Issue: 4
Pages: 934-946
ISSN: 1619-7070 (ISSN-L)
1619-7089
DOI: 10.1007/s00259-019-04567-2
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
Licence: www.springer.com/tdm (tdm)
www.springer.com/tdm (vor)
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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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

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