eanm-logo eanm-logo
European Nuclear Medicine Guide
eanm-logo eanm-logo
European Nuclear Medicine Guide
Chapter 3.3

References

 

1.     CHMP. Annex I Summary of Product Characteristics 2019. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002653/WC500156172.pdf

2.     Poeppel TD, Handkiewicz-Junak D, Andreeff M, Becherer A, Bockisch A, Fricke E, et al. EANM guideline for radionuclide therapy with radium-223 of metastatic castration-resistant prostate cancer. European Journal of Nuclear Medicine and Molecular Imaging 2018;45:824–845. https://doi.org/10.1007/s00259-017-3900-4.

3.     Coleman R, Aksnes A-K, Naume B, Garcia C, Jerusalem G, Piccart M, et al. A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease. Breast Cancer Res Treat 2014;145:411–8. https://doi.org/10.1007/s10549-014-2939-1.

4.     Ueno NT, Tahara RK, Fujii T, Reuben JM, Gao H, Saigal B, et al. Phase II study of Radium‐223 dichloride combined with hormonal therapy for hormone receptor‐positive, bone‐dominant metastatic breast cancer. Cancer Med 2019;9:1025–32. https://doi.org/10.1002/cam4.2780.

5.     Subbiah V, Anderson PM, Kairemo K, Hess KR, Huh WW, Ravi V, et al. Alpha particle Radium 223 dichloride in high-risk osteosarcoma: a phase I dose escalation trial. Clin Cancer Res 2019. https://doi.org/10.1158/1078-0432.CCR-18-3964.

6.     Hindorf C, Chittenden S, Aksnes A-K, Parker C, Flux GD. Quantitative imaging of 223Ra-chloride (Alpharadin) for targeted alpha-emitting radionuclide therapy of bone metastases. Nuclear Medicine Communications 2012;33:726–732. https://doi.org/10.1097/MNM.0b013e328353bb6e.

7.     Hoskin P, Sartor O, O’Sullivan JM, Johannessen DC, Helle SI, Logue J, et al. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology 2014;15:1397–1406. https://doi.org/10.1016/S1470-2045(14)70474-7.

8.     Tombal BF, Loriot Y, Saad F, McDermott RS, Elliott T, Rodriguez-Vida A, et al. Decreased fracture rate by mandating bone-protecting agents in the EORTC 1333/PEACE III trial comparing enzalutamide and Ra223 versus enzalutamide alone: An interim safety analysis. JCO 2019;37:5007–5007. https://doi.org/10.1200/JCO.2019.37.15_suppl.5007.

9.     Lassmann M, Nosske D. Dosimetry of 223Ra-chloride: dose to normal organs and tissues. European Journal of Nuclear Medicine and Molecular Imaging 2013;40:207–212. https://doi.org/10.1007/s00259-012-2265-y.

10.     Carrasquillo JA, O’Donoghue JA, Pandit-Taskar N, Humm JL, Rathkopf DE, Slovin SF, et al. Phase I pharmacokinetic and biodistribution study with escalating doses of 223Ra-dichloride in men with castration-resistant metastatic prostate cancer. European Journal of Nuclear Medicine and Molecular Imaging 2013;40:1384–1393. https://doi.org/10.1007/s00259-013-2427-6.

11.     Chittenden SJ, Hindorf C, Parker CC, Lewington VJ, Pratt BE, Johnson B, et al. A Phase 1, Open-Label Study of the Biodistribution, Pharmacokinetics, and Dosimetry of 223Ra-Dichloride in Patients with Hormone-Refractory Prostate Cancer and Skeletal Metastases. Journal of Nuclear Medicine 2015;56:1304–1309. https://doi.org/10.2967/jnumed.115.157123.

12.     Parker C, Nilsson S, Heinrich D, Helle SI, O’Sullivan JM, Foss\a SD, et al. Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer. New England Journal of Medicine 2013;369:213–223. https://doi.org/10.1056/NEJMoa1213755.

13.     Morris MJ, Loriot Y, Sweeney CJ, Fizazi K, Ryan CJ, Shevrin DH, et al. Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial. Eur J Cancer 2019;114:107–16. https://doi.org/10.1016/j.ejca.2019.04.007.

14.     Sternberg CN, Saad F, Graff JN, Peer A, Vaishampayan UN, Leung E, et al. A randomised phase II trial of three dosing regimens of radium-223 in patients with bone metastatic castration-resistant prostate cancer. Ann Oncol 2020;31:257–65. https://doi.org/10.1016/j.annonc.2019.10.025.

15.     Parker CC, Coleman RE, Sartor O, Vogelzang NJ, Bottomley D, Heinrich D, et al. Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial. European Urology 2017. https://doi.org/10.1016/J.EURURO.2017.06.021.

16.     Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, et al. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2019;20:408–19. https://doi.org/10.1016/S1470-2045(18)30860-X.

17.     Van den Wyngaert T, Tombal B. The changing role of radium-223 in metastatic castrate-resistant prostate cancer: has the EMA missed the mark with revising the label? Q J Nucl Med Mol Imaging 2019;63:170–82. https://doi.org/10.23736/S1824-4785.19.03205-9.