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European Journal of Nuclear Medicine and Molecular Imaging

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Open Access 01-01-2018 | Letter to the Editor

From fixed activities to personalized treatments in radionuclide therapy: lost in translation?

Authors: G. D. Flux, K. Sjogreen Gleisner, C. Chiesa, M. Lassmann, N. Chouin, J. Gear, M. Bardiès, S. Walrand, K. Bacher, U. Eberlein, M. Ljungberg, L. Strigari, E. Visser, M. W. Konijnenberg

Published in: European Journal of Nuclear Medicine and Molecular Imaging | Issue 1/2018

Excerpt

We read with interest the letter by Giammarile et al. [1] addressing our editorial in which we proposed that the European Medicines Agency should allow the option of a dosimetry-based approach to the treatment of cancer with radionuclide therapy [2]. Our editorial was intended to draw attention to the potential legal issues of recommending an approach to treatment that could contravene the European Council Directive 2013/59 [3] and national legislation, as the directive (article 56) states that “For all medical exposure of patients for radiotherapeutic¹ purposes, exposures of target volumes shall be individually planned and their delivery appropriately verified...”. This directive is intended to “lay down basic safety standards for the protection of dangers arising from exposure to ionizing radiation” and emphasizes the need for ‘justification’ and ‘optimization’ of intentional radiation exposures of patients. …

According to the Directive (article 4, definition (81)) “radiotherapeutic” means pertaining to radiotherapy, including nuclear medicine for therapeutic purposes”

Giammarile F, Muylle K, Bolton RD, Kunikowska J, Haberkorn U, Oyen W. Dosimetry in clinical radionuclide therapy: the devil is in the detail. Eur J Nucl Med Mol Imaging. 2017; https://doi.org/10.1007/s00259-017-3820-3.

Chiesa C, Sjogreen Gleisner K, Flux G, Gear J, Walrand S, Bacher K, et al. The conflict between treatment optimization and registration of radiopharmaceuticals with fixed activity posology in oncological nuclear medicine therapy. Eur J Nucl Med Mol Imaging. 2017; https://doi.org/10.1007/s00259-017-3707-3.

Council Directive 2013/59/Euratom. Off J Eur Union. 2014;57. doi:https://doi.org/10.3000/19770677.L_2014.013.eng.

Strigari L, Konijnenberg M, Chiesa C, Bardies M, Du Y, Gleisner KS, et al. The evidence base for the use of internal dosimetry in the clinical practice of molecular radiotherapy. Eur J Nucl Med Mol Imaging. 2014;41:1976–88. https://doi.org/10.1007/s00259-014-2824-5.CrossRefPubMed

Garin E, Rolland Y, Pracht M, Le Sourd S, Laffont S, Mesbah H, et al. High impact of macroaggregated albumin-based tumour dose on response and overall survival in hepatocellular carcinoma patients treated with 90 Y-loaded glass microsphere radioembolization. Liver Int. 2017;37:101–10. https://doi.org/10.1111/liv.13220.CrossRefPubMed

Brans B, Bodei L, Giammarile F, Linden O, Luster M, Oyen WJ, et al. Clinical radionuclide therapy dosimetry: the quest for the "Holy Gray". Eur J Nucl Med Mol Imaging. 2007;34:772–86. https://doi.org/10.1007/s00259-006-0338-5.CrossRefPubMedPubMedCentral

Strigari L, Sciuto R, Rea S, Carpanese L, Pizzi G, Soriani A, et al. Efficacy and toxicity related to treatment of hepatocellular carcinoma with 90Y-SIR spheres: radiobiologic considerations. J Nucl Med. 2010;51:1377–85. https://doi.org/10.2967/jnumed.110.075861.CrossRefPubMed

Sundlov A, Sjogreen-Gleisner K, Svensson J, Ljungberg M, Olsson T, Bernhardt P, et al. Individualised 177Lu-DOTATATE treatment of neuroendocrine tumours based on kidney dosimetry. Eur J Nucl Med Mol Imaging. 2017; https://doi.org/10.1007/s00259-017-3678-4.

Ilan E, Sandstrom M, Wassberg C, Sundin A, Garske-Roman U, Eriksson B, et al. Dose response of pancreatic neuroendocrine tumors treated with peptide receptor radionuclide therapy using 177Lu-DOTATATE. J Nucl Med. 2015;56:177–82. https://doi.org/10.2967/jnumed.114.148437.CrossRefPubMed

10.

Minguez P, Flux G, Genolla J, Delgado A, Rodeno E, Gleisner KS. Whole-remnant and maximum-voxel SPECT/CT dosimetry in I-131-NaI treatments of differentiated thyroid cancer. Med Phys. 2016;43 https://doi.org/10.1118/1.4961742.

11.

Gustafsson J, Brolin G, Cox M, Ljungberg M, Johansson L, Gleisner KS. Uncertainty propagation for SPECT/CT-based renal dosimetry in (177)Lu peptide receptor radionuclide therapy. Phys Med Biol. 2015;60:8329–46. https://doi.org/10.1088/0031-9155/60/21/8329.CrossRefPubMed

12.

Flux GD, Guy MJ, Beddows R, Pryor M, Flower MA. Estimation and implications of random errors in whole-body dosimetry for targeted radionuclide therapy. Phys Med Biol. 2002;47:3211–23.CrossRefPubMed

13.

Chiesa C, Botta F, Coliva A, Maccauro M, Devizzi L, Guidetti A, et al. Absorbed dose and biologically effective dose in patients with high-risk non-Hodgkin's lymphoma treated with high-activity myeloablative 90Y-ibritumomab tiuxetan (Zevalin). Eur J Nucl Med Mol Imaging. 2009;36:1745–57. https://doi.org/10.1007/s00259-009-1141-x.CrossRefPubMed

14.

Wierts R, Brans B, Havekes B, Kemerink GJ, Halders SG, Schaper NN, et al. Dose-response relationship in differentiated thyroid cancer patients undergoing radioiodine treatment assessed by means of 124I PET/CT. J Nucl Med. 2016;57:1027–32. https://doi.org/10.2967/jnumed.115.168799.CrossRefPubMed

15.

Bergsma H, Konijnenberg MW, van der Zwan WA, Kam BL, Teunissen JJ, Kooij PP, et al. Nephrotoxicity after PRRT with Lu-DOTA-octreotate. Eur J Nucl Med Mol Imaging. 2016; https://doi.org/10.1007/s00259-016-3382-9.

16.

Buffa FM, Flux GD, Guy MJ, O'Sullivan JM, McCready VR, Chittenden SJ, et al. A model-based method for the prediction of whole-body absorbed dose and bone marrow toxicity for Re-186-HEDP treatment of skeletal metastases from prostate cancer. Eur J Nucl Med Mol Imaging. 2003;30:1114–24. https://doi.org/10.1007/s00259-003-1197-y.CrossRefPubMed

Title: From fixed activities to personalized treatments in radionuclide therapy: lost in translation?
Authors: G. D. Flux
K. Sjogreen Gleisner
C. Chiesa
M. Lassmann
N. Chouin
J. Gear
M. Bardiès
S. Walrand
K. Bacher
U. Eberlein
M. Ljungberg
L. Strigari
E. Visser
M. W. Konijnenberg
Publication date: 01-01-2018
Publisher: Springer Berlin Heidelberg
Published in: European Journal of Nuclear Medicine and Molecular Imaging / Issue 1/2018
Print ISSN: 1619-7070
Electronic ISSN: 1619-7089
DOI: https://doi.org/10.1007/s00259-017-3859-1

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