Management of bone metastases in refractory prostate cancer - role of denosumab

Clinical Interventions in Aging

Volumn 7, Issue , 2012, Pages 363-372

  Paller, Channing J ^a   Carducci, Michael A ^a   Philips, George K ^b  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b GEORGETOWN UNIVERSITY   (United States)

Author keywords

Bone disease; Denosumab; Prostate cancer

Indexed keywords

ABIRATERONE; ALENDRONIC ACID; ANDROGEN; ATRASENTAN; CABAZITAXEL; CALCIUM; CLODRONIC ACID; DENOSUMAB; DOCETAXEL; ENZALUTAMIDE; OSTEOCLAST DIFFERENTIATION FACTOR; PAMIDRONIC ACID; PLACEBO; PROSTATE SPECIFIC ANTIGEN; RADIUM CHLORIDE RA 223; RECEPTOR ACTIVATOR OF NUCLEAR FACTOR KAPPA B; SIPULEUCEL T; VITAMIN D; ZIBOTENTAN; ZOLEDRONIC ACID;

ANDROGEN DEPRIVATION THERAPY; ANTINEOPLASTIC ACTIVITY; BONE DENSITY; BONE DISEASE; BONE FRAGILITY; BONE METASTASIS; BONE NECROSIS; BONE PAIN; BONE TURNOVER; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER DIAGNOSIS; CANCER EPIDEMIOLOGY; CANCER PROGNOSIS; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL EVALUATION; CLINICAL FEATURE; COMPUTER ASSISTED TOMOGRAPHY; DIAGNOSTIC ACCURACY; DISEASE CONTROL; DISEASE EXACERBATION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CONTROL; DRUG COST; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED DISEASE; DRUG MECHANISM; DRUG MEGADOSE; DRUG METABOLISM; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; ENZYME INHIBITION; FOOD AND DRUG ADMINISTRATION; FRACTURE; HUMAN; HYPOCALCEMIA; HYPOPHOSPHATEMIA; JAW OSTEONECROSIS; MALE; METASTASIS FREE SURVIVAL; METASTASIS POTENTIAL; MONOTHERAPY; OSTEOBLAST; OSTEOCLAST; OSTEOLYSIS; OSTEOPENIA; OSTEOPOROSIS; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROSTATE CANCER; PROTEIN BINDING; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK REDUCTION; SINGLE DRUG DOSE; TREATMENT RESPONSE; UNITED STATES; VITAMIN SUPPLEMENTATION;

ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; BONE NEOPLASMS; DIPHOSPHONATES; DISEASE-FREE SURVIVAL; HUMANS; HYPOCALCEMIA; IMIDAZOLES; MALE; ORCHIECTOMY; OSTEONECROSIS; PROSTATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RANK LIGAND;

EID: 84872283943     PISSN: 11769092     EISSN: 11781998     Source Type: Journal    
DOI: 10.2147/CIA.S27930     Document Type: Review

References (70)

1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011;61(2):69-90.
2. Siegel R, Naishadham D, Jemal A. Cancer statistics. CA Cancer J Clin. 2012;62(1):10-29.
3. de Bono JS, Oudard S, Ozguroglu M, etal; for TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376(9747):1147-1154.
4. Bubendorf L, Schopfer A, Wagner U, etal. Metastatic patterns of prostate cancer: an autopsy study of 1,589 patients. Hum Pathol. 2000;31(5):578-583.
5. Scher HI, Morris MJ, Basch E, Heller G. End points and outcomes in castration-resistant prostate cancer: from clinical trials to clinical practice. J Clin Oncol. 2011;29(27):3695-3704.
6. Ryan CJ, Smith M, De Bono JS, etal. Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) [abstract]. J Clin Oncol. 2012;30(Suppl):LBA4518.
7. Parker C, Heinrich D, O'Sullivan J, etal. Overall survival benefit and safety profile of radium-223 chloride, a first-in-class alpha-pharmaceutical: results from a phase III randomized trial (ALSYMPCA) in patients with castration-resistant prostate cancer (CRPC) with bone metastases [abstract]. J Clin Oncol. 2012;Suppl 5:8.
8. De Bono JS, Fizazi K, Saad F, etal. Primary, secondary and quality-of-life endpoint results from the phase III AFFIRM study of MDV3100, an androgen receptor signaling inhibitor [abstract]. J Clin Oncol. 2012;30(Suppl):4519.
9. Smith MR, Kabbinavar F, Saad F, etal. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol. 2005;23(13):2918-2925.
10. Smith MR, Cook R, Lee KA, Nelson JB. Disease and host characteristics as predictors of time to first bone metastasis and death in men with progressive castration-resistant nonmetastatic prostate cancer. Cancer. 2011;117(10):2077-2085.
11. Smith MR, Saad F, Coleman R, etal. 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(9810):39-46.
12. Fizazi K, Carducci M, Smith M, etal. 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.
13. Roodman GD. Mechanisms of bone metastasis. N Engl J Med. 2004;350(16):1655-1664.
14. Venkitaraman R, Sohaib SA, Barbachano Y, etal. Detection of occult spinal cord compression with magnetic resonance imaging of the spine. Clin Oncol (R Coll Radiol). 2007;19(7):528-531.
15. Even-Sapir E, Metser U, Mishani E, Lievshitz G, Lerman H, Leibovitch I. The detection of bone metastases in patients with high-risk prostate cancer: 99mTc-MDP Planar bone scintigraphy, single-and multi-field-of-view SPECT, 18F-fluoride PET, and 18F-fluoride PET/CT. J Nucl Med. 2006;47(2):287-297.
16. Blair HC, Teitelbaum SL, Ghiselli R, Gluck S. Osteoblastic bone resorption by a polarized vacuolar proton pump. Science. 1989;245(4920): 855-857.
17. Brown JE, Cook RJ, Major P, etal. Bone turnover markers as predictors of skeletal complications in prostate cancer, lung cancer, and other solid tumors. J Natl Cancer Inst. 2005;97(1):59-69.
18. Smith MR, Saad F, Egerdie B, etal. Denosumab and changes in bone turnover markers during androgen deprivation therapy for prostate cancer. J Bone Miner Res. 2011;26(12):2827-2833.
19. Paller CJ, Shiels MS, Rohrmann S, etal. Relationship of sex steroid hormones with bone mineral density (BMD) in a nationally representative sample of men. Clin Endocrinol (Oxf). 2009;70(1):26-34.
20. Gennari L, Nuti R, Bilezikian JP. Aromatase activity and bone homeostasis in men. J Clin Endocrinol Metab. 2004;89(12):5898-5907.
21. Smith MR, McGovern FJ, Zietman AL, etal. Pamidronate to prevent bone loss during androgen-deprivation therapy for prostate cancer. N Engl J Med. 2001;345(13):948-955.
22. Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med. 2005;352(2): 154-164.
23. Saylor PJ, Morton RA, Hancock ML, Barnette KG, Steiner MS, Smith MR. Factors associated with vertebral fractures in men treated with androgen deprivation therapy for prostate cancer. J Urol. 2011; 186(2):482-486.
24. Alibhai SM, Duong-Hua M, Cheung AM, etal. Fracture types and risk factors in men with prostate cancer on androgen deprivation therapy: a matched cohort study of 19,079 men. J Urol. 2010;184(3):918-923.
25. Jones CU, Hunt D, McGowan DG, etal. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011;365(2):107-118.
26. Bolla M, de Reijke TM, Van Tienhoven G, etal; for EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009;360(24):2516-2527.
27. Messing EM, Manola J, Sarosdy M, Wilding G, Crawford ED, Trump D. Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer. N Engl J Med. 1999;341(24):1781-1788.
28. Tannock IF, de Wit R, Berry WR, etal; for TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351(15):1502-1512.
29. de Bono JS, Logothetis CJ, Molina A, etal; for COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364(21):1995-2005.
30. Carducci MA, Saad F, Abrahamsson PA, etal; for Atrasentan Phase III Study Group Institutions. A phase 3 randomized controlled trial of the efficacy and safety of atrasentan in men with metastatic hormone-refractory prostate cancer. Cancer. 2007;110(9):1959-1966.
31. Nelson JB, Fizazi K, Miller K, etal. Phase III study of the efficacy and safety of zibotentan (ZD4054) in patients with bone metastatic castration resistant prostate cancer (CRPC) [abstract]. J Clin Oncol. 2011;29(Suppl 7):117.
32. Yu EY, Massard C, Gross ME, etal. Once-daily dasatinib: expansion of phase II study evaluating safety and efficacy of dasatinib in patients with metastatic castration-resistant prostate cancer. Urology. 2011;77(5):1166-1171.
33. Sartor O. Overview of samarium sm 153 lexidronam in the treatment of painful metastatic bone disease. Rev Urol. 2004;6 Suppl 10:S3-S12.
34. Dearnaley DP, Mason MD, Parmar MK, Sanders K, Sydes MR. Adjuvant therapy with oral sodium clodronate in locally advanced and metastatic prostate cancer: long-term overall survival results from the MRC PR04 and PR05 randomised controlled trials. Lancet Oncol. 2009;10(9):872-876.
35. Michaelson MD, Kaufman DS, Lee H, etal. Randomized controlled trial of annual zoledronic acid to prevent gonadotropin-releasing hormone agonist-induced bone loss in men with prostate cancer. J Clin Oncol. 2007;25(9):1038-1042.
36. Greenspan SL, Nelson JB, Trump DL, Resnick NM. Effect of once-weekly oral alendronate on bone loss in men receiving androgen deprivation therapy for prostate cancer: a randomized trial. Ann Intern Med. 2007;146(6):416-424.
37. Small EJ, Smith MR, Seaman JJ, Petrone S, Kowalski MO. Combined analysis of two multicenter, randomized, placebo-controlled studies of pamidronate disodium for the palliation of bone pain in men with metastatic prostate cancer. J Clin Oncol. 2003;21(23):4277-4284.
38. Saad F, Gleason DM, Murray R, etal; for Zoledronic Acid Prostate Cancer Study Group. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst. 2002;94(19):1458-1468.
39. Kostenuik PJ, Nguyen HQ, McCabe J, etal. Denosumab, a fully human monoclonal antibody to RANKL, inhibits bone resorption and increases BMD in knock-in mice that express chimeric (murine/human) RANKL. J Bone Miner Res. 2009;24(2):182-195.
40. Amgen. XGEVA (denosumab) Injection, for Subcutaneous Use: US Prescribing Information [document on the Internet]. Thousand Oaks, CA: Amgen; [updated 2011]. Available from: http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf. Accessed on May 2, 2012.
41. Fizazi K, Lipton A, Mariette X, etal. Randomized phase II trial of denosumab in patients with bone metastases from prostate cancer, breast cancer, or other neoplasms after intravenous bisphosphonates. J Clin Oncol. 2009;27(10):1564-1571.
42. Henry DH, Costa L, Goldwasser F, etal. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29(9):1125-1132.
43. Lewiecki EM, Bilezikian JP. Denosumab for the treatment of osteoporosis and cancer-related conditions. Clin Pharmacol Ther. 2012;91(1):123-133.
44. Seeman E, Delmas PD, Hanley DA, etal. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010;25(8):1886-1894.
45. Stopeck AT, Lipton A, Body JJ, etal. 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.
46. Lipton A, Steger GG, Figueroa J, etal. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol. 2007;25(28): 4431-4437.
47. Body JJ, Facon T, Coleman RE, etal. A study of the biological receptor activator of nuclear factor-kappaB ligand inhibitor, denosumab, in patients with multiple myeloma or bone metastases from breast cancer. Clin Cancer Res. 2006;12(4):1221-1228.
48. Coleman RE. Risks and benefits of bisphosphonates. Br J Cancer. 2008;98(11):1736-1740.
49. Lipton A, Steger GG, Figueroa J, etal. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res. 2008;14(20):6690-6696.
50. Amgen Incorporated. Prolia™ (Denosumab) injection, for subcutaneous use: US prescribing information [online]. Thousand Oaks, CA: Amgen Inc; 2010. http://pi.amgen.com/united_states/prolia/prolia_pi.pdf. Accessed May 1, 2012.
51. Amgen Incorporated. XGEVA (denosumab) injection, for subcutaneous use: US prescribing information [online]. Thousand Oaks, CA: Amgen Inc; 2010. http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf. Accessed May 1, 2012
52. Amgen Incorporated. Prolia 60 mg Solution for Injection in a Pre-filled Syringe: EU Summary of Product Characteristics. Breda, The Netherlands: Amgen Europe BV; 2010.
53. Bekker PJ, Holloway DL, Rasmussen AS, etal. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004;19(7):1059-1066.
54. Cummings SR, San Martin J, McClung MR, etal; for FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361(8):756-765.
55. Smith MR, Egerdie B, Hernandez Toriz N, etal; for Denosumab HALT Prostate Cancer Study Group. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med. 2009;361(8):745-755.
56. Adler RA, Gill RS. Clinical utility of denosumab for treatment of bone loss in men and women. Clin Interv Aging. 2011;6:119-124.
57. National Osteoperosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2010.
58. Rothstein A. Denosumab Safety: Division of Reproductive and Urologic Products, Center of Drug Evaluation and Research at the Food and Drug Administration [document on the Internet]; [updated 2009]. Available from: http://courses.washington.edu/bonephys/denosumab/Rothstein%20FDA%20deno%20safety.pdf. Accessed on May 2, 2012.
59. Shore N, Smith R, Jievaltas M, etal. Effect of denosumab versus zoledronic acid in patients with castrate-resistant prostate cancer and bone metastases: subgroup analyses by prior SRE and baseline pain. J Clin Oncol. 2011;29(Suppl):4533.
60. Body JJ, Lipton A, Gralow J, etal. Effects of denosumab in patients with bone metastases with and without previous bisphosphonate exposure. J Bone Miner Res. 2010;25(3):440-446.
61. Hale C. ODAC votes to nix Amgen's drug Xgeva for proposed prostate cancer indication. Cancer Lett. 2012;38(7):1.
62. Goldberg P. Xgeva doesn't meet the bar in controversial indication. Cancer Lett. 2012;38(18):8.
63. Mason MD, Sydes MR, Glaholm J, etal; for Medical Research Council PR04 Collaborators. Oral sodium clodronate for nonmetastatic prostate cancer-results of a randomized double-blind placebo-controlled trial: Medical Research Council PR04 (ISRCTN61384873). J Natl Cancer Inst. 2007;99(10):765-776.
64. Nelson JB, Love W, Chin JL, etal; for Atrasentan Phase 3 Study Group. Phase 3, randomized, controlled trial of atrasentan in patients with nonmetastatic, hormone-refractory prostate cancer. Cancer. 2008;113(9):2478-2487.
65. Lee RJ, Smith MR. Osteoclast-targeted therapy for metastatic prostate cancer. Therapy. 2008;5(1):63-72.
66. Snedecor SJ, Carter JA, Kaura S, Botteman M. Cost-effectiveness of zoledronic acid (ZOL) versus denosumab (Dmab) in prevention of skeletal-related events (SREs) in castration-resistant prostate cancer metastatic to the bone (mCRPC). J Clin Oncol. 2011;29(Suppl):4581.
67. Xie J, Namjoshi M, Wu EQ, etal. Economic evaluation of denosumab compared with zoledronic acid in hormone-refractory prostate cancer patients with bone metastases. J Manag Care Pharm. 2011;17(8):621-643.
68. Gyrta T. Amgen's Xgeva hits resistance over cost-benefit debate [article on the Internet]. New York: Dow Jones News Service [updated April 5, 2011; cited February 18, 2012]. Available from: http://www.advfn.com/news_Amgens-Xgeva-Hits-Resistance-Over-Cost-Benefit-Debate_47174840.html. Accessed February 18, 2012. May 2,2012.
69. Gibiansky L, Sutjandra L, Doshi S, etal. Population pharmacokinetic analysis of denosumab in patients with bone metastases from solid tumours. Clin Pharmacokinet. 2012;51(4):247-260.
70. EMC. XGEVA pharmacological properties [homepage on the Internet]. Cambridge: Medicines Compendium; [updated 2012]. Available from: http://www.medicines.org.uk/emc/medicine/24755/SPC/xgeva/. Accessed on May 2, 2012.