271
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Routine use of denosumab for prevention of skeletal-related events in patients with bone metastases from prostate carcinoma in Bulgaria: a prospective observational study

, , ORCID Icon, &
Article: 2366490 | Received 24 Mar 2024, Accepted 06 Jun 2024, Published online: 01 Jul 2024

References

  • International Agency for Research on Cancer. Cancer Fact Sheets: Bulgaria 2020. Available from: https://gco.iarc.fr/today/data/factsheets/populations/100-bulgaria-fact-sheets.pdf.
  • Lu J, Hu D, Zhang Y, et al. Current comprehensive understanding of denosumab (the RANKL neutralizing antibody) in the treatment of bone metastasis of malignant tumors, including pharmacological mechanism and clinical trials. Front Oncol. 2023;13:1. doi: 10.3389/fonc.2023.1133828.
  • Ottosson F, Baco E, Lauritzen PM, et al. The prevalence and locations of bone metastases using whole-body MRI in treatment-naïve intermediate- and high-risk prostate cancer. Eur Radiol. 2021;31(5):2747–10. doi: 10.1007/s00330-020-07363-x.
  • 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):213–223. doi: 10.1056/NEJMoa1213755.
  • Pound CR, Partin AW, Eisenberger MA, et al. Natural history of progression after PSA elevation following radical prostatectomy. JAMA. 1999;281(17):1591–1597. doi: 10.1001/jama.281.17.1591.
  • Phillips WJ, Saad F, Leigh J, et al. Real-world evaluation of primary versus secondary prevention of skeletal-related events in metastatic castration-resistant prostate cancer. Oncologist. 2024:oyae036 (Online ahead of print). doi: 10.1093/oncolo/oyae036.
  • Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377(9768):813–822. doi: 10.1016/S0140-6736(10)62344-6.
  • Nørgaard M, Jensen AØ, Jacobsen JB, et al. Skeletal related events, bone metastasis and survival of prostate cancer: a population based cohort study in Denmark (1999 to 2007). J Urol. 2010;184(1):162–167. doi: 10.1016/j.juro.2010.03.034.
  • Saad F, Gleason DM, Murray R, et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst. 2004;96(11):879–882. doi: 10.1093/jnci/djh141.
  • Coleman R, Hadji P, Body J-J, et al. Bone health in cancer: ESMO Clinical Practice Guidelines. Ann Oncol. 2020;31(12):1650–1663. doi: 10.1016/j.annonc.2020.07.019.
  • European Medicines Agency. Xgeva(R) (denosumab) – Summary of product characteristics: European Medicines Agency [Internet]. 2022 [updated 2022 July25]. Available from https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf.
  • Lipton A, Fizazi K, Stopeck AT, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. Eur J Cancer. 2012;48(16):3082–3092. doi: 10.1016/j.ejca.2012.08.002.
  • Stopeck AT, Lipton A, Body J-J, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28(35):5132–5139. doi: 10.1200/JCO.2010.29.7101.
  • Henry D, Vadhan-Raj S, Hirsh V, et al. Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors. Support Care Cancer. 2014;22(3):679–687. doi: 10.1007/s00520-013-2022-1.
  • Hegemann M, Bedke J, Stenzl A, et al. Denosumab treatment in the management of patients with advanced prostate cancer: clinical evidence and experience. Ther Adv Urol. 2017;9(3-4):81–88. doi: 10.1177/1756287216686018.
  • Scher HI, Morris MJ, Basch E, et al. End points and outcomes in castration-resistant prostate cancer: from clinical trials to clinical practice. J Clin Oncol. 2011;29(27):3695–3704. doi: 10.1200/JCO.2011.35.8648.
  • Cramer JA, Roy A, Burrell A, et al. Medication compliance and persistence: terminology and definitions. Value Health. 2008;11(1):44–47. doi: 10.1111/j.1524-4733.2007.00213.x.
  • Jacobson D, Cadieux B, Higano CS, et al. Risk factors associated with skeletal-related events following discontinuation of denosumab treatment among patients with bone metastases from solid tumors: a real-world machine learning approach. J Bone Oncol. 2022;34:100423. doi: 10.1016/j.jbo.2022.100423.
  • Haslbauer F, Petzer A, Safanda M, et al. Prospective observational study to evaluate the persistence of treatment with denosumab in patients with bone metastases from solid tumors in routine clinical practice: final analysis. Support Care Cancer. 2020;28(4):1855–1865. doi: 10.1007/s00520-019-04988-7.
  • Diel IJ, Greil R, Janssen J, et al. Medication adherence with denosumab in patients with bone metastases from solid tumors treated in routine clinical settings: a retrospective study. Support Care Cancer. 2022;30(11):9267–9278. doi: 10.1007/s00520-022-07333-7.
  • Porubská M, Němcová A. Persistence of denosumab in Slovak patients with bone metastases – a prospective observational study. Klin Onkol. 2023;36(1):54–64. doi: 10.48095/ccko202354.
  • MD Anderson Cancer Center. The Brief Pain Inventory. 1991. Available from: https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html.
  • Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health. 1999;14(1):1–24. doi: 10.1080/08870449908407311.
  • Verbrugghe M, Timmers L, Boons CC, et al. Adherence to oral anticancer agents: healthcare providers’ perceptions, beliefs and shared decision making in Belgium and the Netherlands. Acta Oncol. 2016;55(4):437–443. doi: 10.3109/0284186X.2015.1119307.
  • Morote J, Aguilar A, Planas J, et al. Definition of castrate resistant prostate cancer: new insights. Biomedicines. 2022;10(3):689. doi: 10.3390/biomedicines10030689.
  • Hernandez RK, Quigley J, Pirolli M, et al. Patients with bone metastases from solid tumors initiating treatment with a bone-targeted agent in 2011: a descriptive analysis using oncology clinic data in the US. Support Care Cancer. 2014;22(10):2697–2705. doi: 10.1007/s00520-014-2251-y.
  • Qian Y, Bhowmik D, Kachru N, et al. Longitudinal patterns of bone-targeted agent use among patients with solid tumors and bone metastases in the United States. Support Care Cancer. 2017;25(6):1845–1851. doi: 10.1007/s00520-017-3583-1.
  • Diel I, Ansorge S, Hohmann D, et al. Real-world use of denosumab and bisphosphonates in patients with solid tumours and bone metastases in Germany. Support Care Cancer. 2020;28(11):5223–5233. doi: 10.1007/s00520-020-05357-5.
  • AlZahrani M, Clemons M, Vandermeer L, et al. Real-world practice patterns and attitudes towards de-escalation of bone-modifying agents in patients with bone metastases from breast and prostate cancer: a physician survey. J Bone Oncol. 2021;26:100339. doi: 10.1016/j.jbo.2020.100339.
  • Abousaud AI, Barbee MS, Davis CC, et al. Safety and efficacy of extended dosing intervals of denosumab in patients with solid cancers and bone metastases: a retrospective study. Ther Adv Med Oncol. 2020;12:1758835920982859. doi: 10.1177/1758835920982859.
  • Kettle JK, Patel PB. Feasibility of extended dosing intervals of denosumab. J Oncol Pharm Pract. 2017;24(5):343–347. doi: 10.1177/1078155217703791.
  • Marshall VK, Given BA. Factors associated with medication beliefs in patients with cancer: an integrative review. Oncol Nurs Forum. 2018;45(4):508–526. doi: 10.1188/18.Onf.508-526.