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Practice Guideline
. 2022 Jun 1;47(6):503-511.
doi: 10.1097/RLU.0000000000004182.

ACR-ACNM-ASTRO-SNMMI Practice Parameter for Lutetium-177 (Lu-177) DOTATATE Therapy

Affiliations
Practice Guideline

ACR-ACNM-ASTRO-SNMMI Practice Parameter for Lutetium-177 (Lu-177) DOTATATE Therapy

Charito Love et al. Clin Nucl Med. .

Abstract

Objectives: This practice parameter (PP) for Lutetium-177 (Lu-177) DOTATATE peptide receptor radionuclide therapy (PRRT) aims to guide authorized users in selection of appropriate adult candidates with gastroeneropancreatic neuroendocrine tumors (GEP-NETs) from foregut, midgut, and hindgut. The essential selection criteria include somatostatin receptor-positive GEP-NETs, which are usually inoperable and progressed despite standard therapy. Lu-177 DOTATATE is a radiopharmaceutical with high avidity for somatostatin receptors that are overexpressed by these tumors. This document ensures safe handling of Lu-177 DOTATATE by the authorized users and safe management of affected patients.

Methods: The document was developed according to the systematic process developed by the American College of Radiology (ACR) and described on the ACR Web site (https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards). The PP development was led by 2 ACR Committees on Practice Parameters (Nuclear Medicine and Molecular Imaging and Radiation Oncology) collaboratively with the American College of Nuclear Medicine, American Society of Radiation Oncology, and Society of Nuclear Medicine and Molecular Imaging.

Results: The Lu-177 DOTATATE PP reviewed pharmacology, indications, adverse effects, personnel qualifications, and required clinical evaluation before starting the treatment, as well as the recommended posttherapy monitoring, quality assurance, documentation, and appropriate radiation safety instructions provided in written form and explained to the patients.

Conclusions: Lu-177 DOTATATE is available for therapy of inoperable and/or advanced GEP-NETs when conventional therapy had failed. It can reduce tumor size, improve symptoms, and increase the progression free survival. The PP document provides clinical guidance for authorized users to assure an appropriate, consistent, and safe practice of Lu-177 DOTATATE.

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Conflict of interest statement

Conflicts of interest and sources of funding: N.B.D. reports a grant from Boston Scientific, consulting fees from Boston Scientific, and honoraria from MedLearning. L.B. reports a grant from AAA Novartis, and participation on an advisory board for AAA Novartis. R.K.J.B. reports participation on an advisory board for Covera Health. E.C.G. reports consulting fees from Advanced Accelerator Applications. R.F.H. reports funding from National Institutes of Health/National Cancer Institute, and a leadership role as Chairman of the Radiopharmaceutical Therapy Subcommittee of the American Association of Physicists in Medicine. T.A.H. reports grants or contracts from Philips and Clovis Oncology, consulting fees from Curium and ITM, and participation on advisory boards for Ipsen and Blue Earth Diagnostics. D.A.P. reports grants from Siemens, Nordic Nanovector, Progenics, and 511 Pharma, and consulting fees from Siemens, 511 Pharma, Progenics, Actinium, and Ipsen. B.S.-B. reports a grant from Blue Earth Diagnostics, honoraria from PETNET and Blue Earth Diagnostics, and a leadership role as Society of Nuclear Medicine and Molecular Imaging (SNMMI) co-chair of outreach committee secretary of American College of Nuclear Medicine, Central Chapter SNMMI, and Academic Council SNMMI. R.M.S. reports a grant from Endocyte Inc. For the remaining authors, none were declared.

References

    1. American College of Radiology. ACR-AAPM-SPR technical standard for therapeutic procedures using radiopharmaceuticals. Available at: https://www.acr.org/-/media/ACR/Files/Practice-Parameters/RadioPharm.pdf... . Accessed September 5, 2019.
    1. Yao JC, Hassan M, Phan A, et al. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol . 2008;26:3063–3072.
    1. Hamiditabar M, Ali M, Roys J, et al. Peptide receptor radionuclide therapy with 177 Lu-Octreotate in patients with somatostatin receptor expressing neuroendocrine tumors: six years’ assessment. Clin Nucl Med . 2017;42:436–443.
    1. Kwekkeboom DJ, de Herder WW, Kam BL, et al. Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival. J Clin Oncol . 2008;26:2124–2130.
    1. Bodei L, Kidd M, Paganelli G, et al. Long-term tolerability of PRRT in 807 patients with neuroendocrine tumours: the value and limitations of clinical factors. Eur J Nucl Med Mol Imaging . 2015;42:5–19.

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