Novel bone protective agents in patients with prostate cancer

Nikolaos A. Kostakopoulos, Athanasios Papatsoris

Abstract


Prostate cancer is the most commonly diagnosed non-cutaneous cancer and the second leading cause of cancer death in men. The tissue tropism of prostate cancer for bone coupled with the skeletal- related adverse effects of Androgen Deprivation Therapy has led to heightened awareness of SREs in castration resistant prostate cancer. In the European Association of Urology updated 2015 guidelines on the management of castration resistant prostate cancer the grade of recommendation is ‘A’ for offering bone protective agents to patients with bone metastases (denosumab being superior to zoledronic acid). The results of larger ongoing studies that assess the efficacy, safety and cost-effectiveness of denosumab are warranted.

 

O καρκίνος του προστάτη αποτελεί τον πιο συχνά διαγνωζόμενο μη δερματικό καρκίνο και τη δεύτερη πιο συχνή αιτία θανάτου από καρκίνο στους άνδρες. Ο ιστικός τροπισμός του προστατικού καρκίνου για τα οστά σε συνδυασμό με τις σχετιζόμενες με τα οστά ανεπιθύμητες ενέργειες (SREs) της αντιανδρογονικής αγωγής, έχουν οδηγήσει σε αυξημένη προσοχή στα SREs στον ευνουχοάντοχο καρκίνο του προστάτη (CRPC). Σύμφωνα με τις πιο πρόσφατες οδηγίες της Ευρωπαικής Ουρολογικής Εταιρίας το 2015 για τη διαχείριση ασθενών με CRPC, προτείνεται με βαθμό σύστασης ¨Α¨, η προσφορά οστεοπροστατευτικών παραγόντων σε ασθενείς με οστικές μεταστάσεις (με το denosumab να υπερτερεί έναντι του ζολεδρονικού οξέος). Τα αποτελέσματα των σε εξέλιξη μελετών που επεξεργάζονται την αποτελεσματικότητα, ασφάλεια και κόστος του denosumab είναι εγγυήμενα.


Keywords


prostate cancer; castration; bone protective agents; denosumab; bisphosphonates; radium 223; abiraterone; enzalutamide; καρκίνος προστάτη; οστεοπροστασία; οστεοπροστατευτικοί παράγοντες; ευνουχοαντοχή

Full Text:

PDF

References


Heidenreich A, Aus G, Bolla M, et al. EAU guidelines on prostate cancer. Eur Urol 2008; 53:68 - 80.

Heidenreich A, Bastian PJ, Bellmunt J, et al. Guidelines on prostate cancer. In European Association of Urology (EAU) Guidelines, edition presented at the 28th Annual EAU Congress, Milan; 2013.

Saad F, Gleason DM, Murray R, et al. A randomized, placebo - controlled trial of zoledronic acid in patients with hormone refractory metastatic prostate carcinoma. J Natl Cancer Inst 2002;94(19):1458 - 68.

Marco RA, Sheth DS, Boland PJ, et al. Functional and oncological outcome of acetabular reconstruction for the treatment of metastatic disease. J Bone Joint Surg Am 2000;82(5):642 - 51.

Dy SM, Asch SM, Naeim A, et al. Evidence - based standards for cancer pain management. J Clin Oncol 2008;26(23):3879 - 85.

Aapro M, Abrahamsson PA, Body JJ, et al. Guidance on the use of bisphosphonates in solid tumours: recommendations of an international expert panel. Ann Oncol 2008;19(3):420 - 32.

Heidenreich A, et al. Therapies used in Prostate cancer Patients by European Urologists: Data on Indication with a Focus on Expectations, Percieved barriers and Guideline Compliance Related to the Use of Bisphosphonates. Urol Int 2012;89:30 - 38.

U.S. Food and Drug Administration. Denosumab (Xgeva, Amgen) approval for the prevention of skeletal - related events in patients with bone metastases from solid tumors. Updated July 2, 2013. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125320s007ltr.pdf. Accessed April 11, 2015.

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 - 23.

S Gillessen et al. Management of patients with advanced prostate cancer: Recommendations of the St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) 2015.

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;377:813 - 22.

von Moos Roger, et al. Pain and health - related quality of life in patients with advanced solid tumours and bone metastases: intergrated results from three randomized, double - blind studies of denosumab and zolendronic acid. Support Care Cancer 2013;21:3497 - 3507.

Smith MR, et al. Randomized Controlled Trial of Early Zoledronic Acid in Men With Castration - Sensitive Prostate Cancer and Bone Metastases: Results of CALGB 90202 (Alliance). J Clin Oncol. 2014;32:1143 - 50.

Lipton A, Fizazi K., Stopeck A.T. 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;48:3082 - 92.

Hagiwara M, Delea TE, Cong Z, et al. Utilization of intravenous bisphosphonates in patients with bone metastases secondary to breast, lung,or prostate cancer. Support Care Cancer 2013; 22:103 - 113.

Stopeck A, et al. Cost - effectiveness of denosumab vs zoledronic acid for prevention of skeletal - related events in patients with solid tumors and bone metastases in the United States. J Med Econ 2012; 15:12 - 23.

Mottel N, Bellmunt J, Briers E, et al. Guidelines on prostate cancer. In European Association of Urology (EAU) Guidelines, edition presented at the 30th Annual EAU Congress. Madrid 2015.

Smith MR, et al. Denosumab and bone - metastasis - free survival in men with castration - resistant prostate cancer: results of a phase 3, randomised, placebo - controlled trial. Lancet 2012;379: 39 - 46.

Peddi P, et al. Denosumab in patients with cancer and skeletal metastases: a systematic review and meta - analysis. Cancer Treat Rev. 2013;39(1):97 - 104.

Dellis A, Papatsoris AG. Denosumab as a promising novel bone - targeted agent in castration resistant prostate cancer. Expert Opin Biol Ther. 2014;14(1):7 - 10.

Qi WX, Tang LN, He AN, et al. Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta - analysis of seven randomized controlled trials. Int J Clin Oncol 2013; Epub ahead of print.

Pazianas M. Osteonecrosis of the jaw and the role of macrophages. J Natl Cancer Inst 2010;103:232 - 40.

Vahtsevanos K, Kyrgidis A, Verrou E, et al. Longitudinal cohort study of risk factors in cancer patients of bisphosphonate - related osteonecrosis of the jaw. J Clin Oncol 2009;27(32):5356 - 62.

van Poznak CH, Temin S, Yee GC, et al. ASCO Clinical practice guideline update on the role of bone - modifying agents in metastatic breast cancer. JCO 2001;29(9):1221 - 7.

Snedecor SJ, Carter JA, Kaura S, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration - resistant prostate cancer: a cost - effectivenessanalysis. J Med Econ 2013;16(1):19 - 29.

Dellis A, Papatsoris A. Cost - effectiveness of denosumab as a bone protective agent for patients with castration resistant prostate cancer. Expert Rev Pharmacoecon Outcomes Res. 2016;25(6):697-707 [Epub ahead of print].

Dellis A, Papatsoris AG. The economics of abiraterone acetate for castration - resistant prostate cancer. Expert Rev Pharmacoecon Outcomes Res. 2014;14(2):175 - 9.

Logothetis CJ, Basch E, Molina A, et al. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal - related events in patients with metastatic castration - resistant prostate cancer: exploratory analysis of data from the COU - AA - 301 randomised trial. Lancet Oncol. 2012;13(12):1210 - 1217.

Smith MR, et al. Denosumab and Bone Metastasis - Free Survival in Men With Nonmetastatic Castration - Resistant Prostate Cancer: Exploratory Analyses by Baseline Prostate - Specific Antigen Doubling Time. J Clin Oncol. 2013; 31(30): 3800 - 3806.

Nilsson S. Radium - 223 dichloride for the treatment of bone metastatic castration - resistant prostate cancer: an evaluation of its safety. Expert Opin Drug Saf 2015; 14: 1127 - 36.

Smith DC, Smith MR, Small EJ, et al. Phase 2 study of Cabozantinib (XL 184) in a cohort of patients with castration - resistant prostate cancer (CRPC) and measurable soft tissue disease. J Clin Oncol 2012; 30.




DOI: http://dx.doi.org/10.19264/hj.v28i3.136