Radium-223 Dichloride: A Review of Its Use in Patients with Castration-Resistant Prostate Cancer with Symptomatic Bone Metastases

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• 作者：Matt Shirley (1)
  Paul L. McCormack (1)
  
• 刊名：Drugs
• 出版年：2014
• 出版时间：April 2014
• 年：2014
• 卷：74
• 期：5
• 页码：579-586
• 全文大小：419 KB
• 参考文献：1. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin. 2011;61(2):69-0.
  2. Kirby M, Hirst C, Crawford ED. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract. 2011;65(11):1180-2.
  3. Alva A, Hussain M. The changing natural history of metastatic prostate cancer. Cancer J. 2013;19(1):19-4.
  4. Carles J, Castellano D, Climent Má, et al. Castration-resistant metastatic prostate cancer: current status and treatment possibilities. Clin Transl Oncol. 2012;14(3):169-6.
  5. El-Amm J, Aragon-Ching JB. The changing landscape in the treatment of metastatic castration-resistant prostate cancer. Ther Adv Med Oncol. 2013;5(1):25-0.
  6. Mukherji D, Eichholz A, De Bono JS. Management of metastatic castration-resistant prostate cancer: recent advances. Drugs. 2012;72(8):1011-8.
  7. Pochon S. Drugs in clinical development for prostate cancer: summary and table. Pharm Med. 2011;25(6):387-04.
  8. Amaral TMS, Macedo D, Fernandes I, et al. Castration-resistant prostate cancer: mechanisms, targets, and treatment. Prostate Cancer. 2012;2012(327253):1-1.
  9. Cookson MS, Roth BJ, Dahm P, et al. Castration-resistant prostate cancer: AUA guideline. J Urol. 2013;190(2):429-8.
  10. Omlin A, Pezaro C, Mukherji D, et al. Improved survival in a cohort of trial participants with metastatic castration-resistant prostate cancer demonstrates the need for updated prognostic nomograms. Eur Urol. 2013;64(2):300-.
  11. Saylor PJ, Lee RJ, Smith MR. Emerging therapies to prevent skeletal morbidity in men with prostate cancer. J Clin Oncol. 2011;29(27):3705-4.
  12. Lange PH, Vessella RL. Mechanisms, hypotheses and questions regarding prostate cancer micrometastases to bone. Cancer Metastasis Rev. 1999;17(4):331-.
  13. Saad F, Hotte SJ. Guidelines for the management of castrate-resistant prostate cancer. Can Urol Assoc J. 2010;4(6):380-.
  14. Lewington VJ. Bone-seeking radionuclides for therapy. J Nucl Med. 2005;46(1 Suppl):38S-7S.
  15. Lewis B, Sartor O. Radiation-based approaches for therapy and palliation of advanced prostate cancer. Curr Opin Urol. 2012;22(3):183-.
  16. US FDA. Xofigo (radium Ra 223 dichloride) injection: prescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203971lbl.pdf. Accessed 24 Feb 2014.
  17. European Medicines Agency. Xofigo: summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002653/WC500156172.pdf. Accessed 24 Feb 2014.
  18. Heier-Baardson H, Dornish M. Lack of protective effect by hypoxia on alpha particle radiation from radium-223 [abstract no. 855]. EJC Suppl. 2010;8(5):216.
  19. Henriksen G, Fisher DR, Roeske JC, et al. Targeting of osseous sites with α-emitting ²²³Ra: comparison with the β-emitter ⁸⁹Sr in mice. J Nucl Med. 2003;44(2):252-.
  20. Nilsson S, Larsen RH, Foss? SD, et al. First clinical experience with α-emitting radium-223 in the treatment of skeletal metastases. Clin Cancer Res. 2005;11(12):4451-.
  21. Nilsson S, Franzén L, Parker C, et al. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007;8(7):587-4.
  22. Chittenden S, Hindorf C, Aksnes A, et al. Dosimetry and pharmacokinetics of ²²³Ra chloride in patients with bone metastases due to hormone refractory prostate cancer [abstract no. P0019]. Eur J Nucl Med Mol Imaging. 2012;39(2 Suppl):S308-.
  23. Lewington V, Parker C, Hindorf C, et al. Radium-223 chloride, a first-in-class alpha-pharmaceutical for patients with castration-resistant prostate cancer (CRPC) and bone metastases: biodistribution/dosimetry compared to overall safety profile [abstract no. e15009]. J Clin Oncol. 2010;28(15 Suppl).
  24. Carrasquillo JA, O’Donoghue JA, Pandit-Taskar N, et al. Phase I pharmacokinetic and biodistribution study with escalating doses of ²²³Ra-dichloride in men with castration-resistant metastatic prostate cancer. Eur J Nucl Med Mol Imaging. 2013;40(9):1384-3.
  25. McDevitt MR, Sgouros G, Finn RD, et al. Radioimmunotherapy with alpha-emitting nuclides. Eur J Nucl Med. 1998;25(9):1341-1.
  26. Bruland ?S, Nilsson S, Fisher DR, et al. High-linear energy transfer irradiation targeted to skeletal metastases by the α-emitter ²²³Ra: adjuvant or alternative to conventional modalities? Clin Cancer Res. 2006;12(20 Suppl):6250s-s.
  27. Franken NAP, Hovingh S, Ten Cate R, et al. Relative biological effectiveness of high linear energy transfer α-particles for the induction of DNA-double-strand breaks, chromosome aberrations and reproductive cell death in SW-1573 lung tumour cells. Oncol Rep. 2012;27(3):769-4.
  28. Baidoo KE, Yong K, Brechbiel MW. Molecular pathways: targeted α-particle radiation therapy. Clin Cancer Res. 2013;19(3):530-.
  29. Lassmann M, Nosske D. Dosimetry of ²²³Ra-chloride: dose to normal organs and tissues. Eur J Nucl Med Mol Imaging. 2013;40(2):207-2.
  30. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213-3.
  31. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-5.
  32. Parker C, Heinrich D, O’Sullivan JM, et al. Overall survival benefit of radium-223 chloride (Alpharadin? in the treatment of patients with symptomatic bone metastases in castration-resistant prostate cancer (CRPC): a phase III randomized trial (ALSYMPCA) [abstract no. 1LBA]. Eur J Cancer. 2011;47(Suppl 2):3.
  33. Vogelzang N, Parker C, Nilsson S, et al. Updated analysis of radium-223 dichloride impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase 3 randomized trial (ALSYMPCA) [abstract no. 11 plus poster]. J Clin Oncol. 2013;31(6 Suppl):11.
  34. Parker C, O’Bryan-Tear CG, Bolstad B, et al. Alkaline phosphatase (ALP) normalization and overall survival in patients with bone metastases from castration-resistant prostate cancer (CRPC) treated with radium-223 [abstract no. 49]. J Clin Oncol. 2011;29(7 Suppl):49.
  35. Nilsson S, Sartor AO, Bruland OS, et al. Pain analyses from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in castration-resistant prostate cancer (CRPC) patients with bone metastases [abstract no. 5038]. J Clin Oncol. 2013;31(15 Suppl):5038.
  36. Tomblyn M, Nilsson S, Vogelzang N, et al. Pain and quality of life (QoL) analyses from the phase 3 randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in castration-resistant prostate cancer (CRPC) patients with bone metastases [abstract no. 714]. J Urol. 2013;189(4 Suppl):e293.
  37. Esper P, Mo F, Chodak G, et al. Measuring quality of life in men with prostate cancer using the Functional Assessment of Cancer Therapy-Prostate instrument. Urology. 1997;50(6):920-.
  38. Parker CC, Pascoe S, Chodacki A, et al. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013;63(2):189-7.
  39. Edge SB, Byrd DR, Compton CC, et al., editors. AJCC Cancer Staging Manual. 7th ed. New York: Springer; 2010.
  40. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guideline^?): prostate cancer (Version 1.2014). 2014. http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed 24 Feb 2014.
  41. Harrison MR, Wong TZ, Armstrong AJ, et al. Radium-223 chloride: a potential new treatment for castration-resistant prostate cancer patients with metastatic bone disease. Cancer Manag Res. 2013;5(1):1-4.
  42. Bayer. A re-treatment safety study of radium-223 dichloride in subjects with castration-resistant prostate cancer with bone metastases who received an initial course of six doses of radium-223 dichloride 50?kBq/kg every four weeks [ClinicalTrials.gov identifier: NCT01934790]. US National Institutes of Health, ClinicalTrials.gov (online). 2014. http://clinicaltrials.gov/ct2/show/NCT01934790?term=NCT01934790&rank=1. Accessed 24 Feb 2014.
  43. Bayer. A randomized open-label phase IIa study evaluating the efficacy and safety of radium-223 dichloride in combination with abiraterone acetate or enzalutamide in subjects with CRPC who have bone metastases [ClinicalTrials.gov identifier: NCT02034552]. US National Institutes of Health. ClinicalTrials.gov (online). 2014. http://clinicaltrials.gov/ct2/show/record/NCT02034552?term=NCT02034552&rank=1. Accessed 24 Feb 2014.
  44. Algeta ASA. A phase I/IIa study of safety and efficacy of Alpharadin^? with docetaxel in patients with bone metastasis from castration-resistant prostate cancer [ClinicalTrials.gov identifier: NCT01106352]. US National Institutes of Health. ClinicalTrials.gov (online). 2014. http://clinicaltrials.gov/ct2/show/record/NCT01106352?term=NCT01106352&rank=1. Accessed 24 Feb 2014.
  
• 作者单位：Matt Shirley (1)
  Paul L. McCormack (1)
  
  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand
  
• ISSN：1179-1950

文摘

Radium-223 dichloride (Xofigo?; formerly Alpharadin? [hereafter referred to as radium-223] is a first-in-class alpha particle-emitting radiopharmaceutical that has recently been approved for the treatment of patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastatic disease. Radium-223 is a calcium mimetic, which targets bone, delivering cytotoxic radiation to the sites of bone metastases. In the recently reported Alpharadin?in Symptomatic Prostate Cancer (ALSYMPCA) phase III study, radium-223 was associated with significantly improved overall survival compared with placebo, making it the first bone-targeted CRPC therapy for which an overall survival benefit has been demonstrated. The ALSYMPCA study also demonstrated the beneficial effects of radium-223 on disease-related symptomatic skeletal events, pain and health-related quality of life. Radium-223 was generally well tolerated, being associated with low rates of myelosuppression and generally mild gastrointestinal adverse events. Thus, radium-223 is a valuable addition to the treatment options for this poor-prognosis population.