Emerging therapies to prevent skeletal morbidity in men with prostate cancer

Journal of Clinical Oncology

Volumn 29, Issue 27, 2011, Pages 3705-3714

  Saylor, Philip J ^a   Lee, Richard J ^a   Smith, Matthew R ^a  

^a MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID; ANTINEOPLASTIC AGENT; ATRASENTAN; BISPHOSPHONIC ACID DERIVATIVE; CLODRONIC ACID; DASATINIB; DENOSUMAB; DOCETAXEL; ENDOTHELIN A RECEPTOR ANTAGONIST; ESTROGEN; MITOXANTRONE; NERIDRONIC ACID; PAMIDRONIC ACID; PREDNISONE; PROSTATE ANTIGEN; RADIOISOTOPE; RADIUM 223; RILOTUMUMAB; SELECTIVE ESTROGEN RECEPTOR MODULATOR; TOREMIFENE; UNCLASSIFIED DRUG; XL 184; ZIBOTENTAN; ZOLEDRONIC ACID;

ANALGESIA; ANDROGEN DEPRIVATION THERAPY; BONE DENSITY; BONE METASTASIS; CASTRATION RESISTANT PROSTATE CANCER; DRUG INDUCED DISEASE; FEMUR NECK; FRAGILITY FRACTURE; GLEASON SCORE; HUMAN; KIDNEY FAILURE; METASTASIS; MULTIPLE CYCLE TREATMENT; NEPHROTOXICITY; OSTEOCLAST ACTIVITY; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK REDUCTION; SECONDARY OSTEOPOROSIS; UNSPECIFIED SIDE EFFECT; VENOUS THROMBOEMBOLISM; VERTEBRA FRACTURE;

ANTIBODIES, MONOCLONAL; BONE DENSITY CONSERVATION AGENTS; BONE NEOPLASMS; DIPHOSPHONATES; HUMANS; MALE; PROSTATIC NEOPLASMS; RADIOPHARMACEUTICALS; RANK LIGAND;

EID: 80053077567     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.34.4994     Document Type: Review

References (73)

1. Jemal A, Siegel R, Xu J, et al: Cancer statistics, 2010. CA Cancer J Clin 60:277-300, 2010
2. Petrylak DP, Tangen CM, Hussain MH, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004 (Pubitemid 39315318)
3. Tannock IF, De Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004 (Pubitemid 39315317)
4. Gullberg B, Johnell O, Kanis JA: World-wide projections for hip fracture. Osteoporos Int 7:407- 413, 1997
5. US Department of Health and Human Services: Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD, US Department of Health and Human Services, Office of the Surgeon General, 2004
6. Bilezikian JP: Osteoporosis in men. J Clin Endocrinol Metab 84:3431-3434, 1999
7. Greenspan SL, Nelson JB, Trump DL, et al: Effect of once-weekly oral alendronate on bone loss in men receiving androgen deprivation therapy for prostate cancer: A randomized trial. Ann Intern Med 146:416-424, 2007 (Pubitemid 351650576)
8. Michaelson MD, Kaufman DS, Lee H, et al: Randomized controlled trial of annual zoledronic acid to prevent gonadotropin-releasing hormone agonistinduced bone loss in men with prostate cancer. J Clin Oncol 25:1038-1042, 2007 (Pubitemid 46596753)
9. Mittan D, Lee S, Miller E, et al: Bone loss following hypogonadism in men with prostate cancer treated with GnRH analogs. J Clin Endocrinol Metab 87:3656-3661, 2002 (Pubitemid 34879508)
10. Smith MR, McGovern FJ, Zietman AL, et al: Pamidronate to prevent bone loss during androgendeprivation therapy for prostate cancer. N Engl J Med 345:948-955, 2001
11. Shahinian VB, Kuo YF, Freeman JL, et al: Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med 352:154-164, 2005 (Pubitemid 40096612)
12. Smith MR, Lee WC, Brandman J, et al: Gonadotropin-releasing hormone agonists and fracture risk: A claims-based cohort study of men with nonmetastatic prostate cancer. J Clin Oncol 23: 7897-7903, 2005 (Pubitemid 46657388)
13. Kanis JA, Borgstrom F, De Laet, et al: Assessment of fracture risk. Osteoporos Int 16:581-589, 2005 (Pubitemid 40897454)
14. Boyle WJ, Simonet WS, Lacey DL: Osteoclast differentiation and activation. Nature 423:337-342, 2003 (Pubitemid 40852708)
15. Boyce BF, Xing L: Biology of RANK, RANKL, and osteoprotegerin. Arthritis Res Ther 9:S1, 2007 (suppl 1)
16. Greendale GA, Edelstein S, Barrett-Connor E: Endogenous sex steroids and bone mineral density in older women and men: The Rancho Bernardo Study. J Bone Miner Res 12:1833-1843, 1997
17. Khosla S, Melton LJ 3rd, Atkinson EJ, et al: Relationship of serum sex steroid levels to longitudinal changes in bone density in young versus elderly men. J Clin Endocrinol Metab 86:3555-3561, 2001 (Pubitemid 32755943)
18. Slemenda CW, Longcope C, Zhou L, et al: Sex steroids and bone mass in older men: Positive associations with serum estrogens and negative associations with androgens. J Clin Invest 100: 1755-1759, 1997 (Pubitemid 27431332)
19. Barrett-Connor E, Mueller JE, Von Mühlen DG, et al: Low levels of estradiol are associated with vertebral fractures in older men, but not women: The Rancho Bernardo Study. J Clin Endocrinol Metab 85:219-223, 2000 (Pubitemid 32268817)
20. LeBlanc ES, Nielson CM, Marshall LM, et al: The effects of serum testosterone, estradiol, and sex hormone binding globulin levels on fracture risk in older men. J Clin Endocrinol Metab 94:3337-3346, 2009
21. Mellström D, Johnell O, Ljunggren O, et al: Free testosterone is an independent predictor of BMD and prevalent fractures in elderly men: MrOS Sweden. J Bone Miner Res 21:529-535, 2006
22. Oefelein MG, Feng A, Scolieri MJ, et al: Reassessment of the definition of castrate levels of testosterone: Implications for clinical decision making. Urology 56:1021-1024, 2000
23. Smith MR: Obesity and sex steroids during gonadotropin-releasing hormone agonist treatment for prostate cancer. Clin Cancer Res 13:241-245, 2007
24. Roodman GD: Mechanisms of bone metastasis. N Engl J Med 350:1655-1664, 2004
25. Demers LM, Costa L, Lipton A: Biochemical markers and skeletal metastases. Cancer 88:2919- 2926, 2000 (suppl 12)
26. Cook RJ, Coleman R, Brown J, et al: Markers of bone metabolism and survival in men with hormone-refractory metastatic prostate cancer. Clin Cancer Res 12:3361-3367, 2006
27. Clarke NW, McClure J, George NJ: Osteoblast function and osteomalacia in metastatic prostate cancer. Eur Urol 24:286-290, 1993 (Pubitemid 23246064)
28. Brown JE, Cook RJ, Major P, et al: Bone turnover markers as predictors of skeletal complications in prostate cancer, lung cancer, and other solid tumors. J Natl Cancer Inst 97:59-69, 2005
29. Rogers MJ, Watts DJ, Russell RG: Overview of bisphosphonates. Cancer 80:1652-1660, 1997 (suppl 8)
30. Roodman GD, Dougall WC: RANK ligand as a therapeutic target for bone metastases and multiple myeloma. Cancer Treat Rev 34:92-101, 2008 (Pubitemid 351181016)
31. Bekker PJ, Holloway DL, Rasmussen AS, et al: A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res 19: 1059-1066, 2004 (Pubitemid 41110556)
32. Paes FM, Serafini AN: Systemic metabolic radiopharmaceutical therapy in the treatment of metastatic bone pain. Semin Nucl Med 40:89-104, 2010
33. 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 377:813-822, 2011
34. Bayer HealthCare: Bayer's investigational compound radium-223 chloride met its primary endpoint of significantly improving overall survival in a phase III trial in patients with castration-resistant prostate cancer that has spread to the bone. http:// pharma.bayer.com/html/pdf/news-room115.pdf
35. Nelson JB, Love W, Chin JL, et al: Phase 3, randomized, controlled trial of atrasentan in patients with nonmetastatic, hormone-refractory prostate cancer. Cancer 113:2478-2487, 2008
36. Carducci MA, Saad F, Abrahamsson PA, et al: A phase 3 randomized controlled trial of the efficacy and safety of atrasentan in men with metastatic hormone-refractory prostate cancer. Cancer 110: 1959-1966, 2007 (Pubitemid 350036854)
37. Diamond TH, Winters J, Smith A, et al: The antiosteoporotic efficacy of intravenous pamidronate in men with prostate carcinoma receiving combined androgen blockade: A double blind, randomized, placebocontrolled crossover study. Cancer 92:1444-1450, 2001 (Pubitemid 32947828)
38. Smith MR, Eastham J, Gleason DM, et al: Randomized controlled trial of zoledronic acid to prevent bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer. J Urol 169:2008-2012, 2003
39. Morabito N, Gaudio A, Lasco A, et al: Neridronate prevents bone loss in patients receiving androgen deprivation therapy for prostate cancer. J Bone Miner Res 19:1766-1770, 2004
40. Smith MR, Egerdie B, Hernaaposndez Toriz N, et al: Denosumab in men receiving androgen-deprivation therapy for prostate cancer.NEngl JMed361:745-755, 2009
41. Smith MR, Fallon MA, Lee H: Raloxifene to prevent gonadotropin-releasing hormone agonistinduced bone loss in men with prostate cancer: A randomized controlled trial. J Clin Endocrinol Metab 89:3841-3846, 2004 (Pubitemid 39071482)
42. Smith MR, Malkowicz SB, Chu F, et al: Toremifene increases bone mineral density in men receiving androgen deprivation therapy for prostate cancer: Interim analysis of a multicenter phase 3 clinical study. J Urol 179:152-155, 2008 (Pubitemid 350216737)
43. Smith MR, Morton RA, Barnette KG, et al: Toremifene to reduce fracture risk in men receiving androgen deprivation therapy for prostate cancer. J Urol 184:1316-1321, 2010
44. Seeman E, Bianchi G, Khosla S, et al: Bone fragility in men: Where are we? Osteoporos Int 17:1577-1583, 2006 (Pubitemid 44477616)
45. National Comprehensive Cancer Network: National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Prostate Cancer, 2010. http://www.nccn.org/professionals/physician-gls/PDF/prostate.pdf
46. Adler RA, Hastings FW, Petkov VI: Treatment thresholds for osteoporosis in men on androgen deprivation therapy: T-score versus FRAX. Osteoporos Int 21:647-653, 2010
47. Saylor PJ, Kaufman DS, Michaelson MD, et al: Application of a fracture risk algorithm to men treated with androgen deprivation therapy for prostate cancer. J Urol 183:2200-2205, 2010
48. Mason MD, Sydes MR, Glaholm J, et al: Oral sodium clodronate for nonmetastatic prostate cancer: Results of a randomized double-blind placebocontrolled trial - Medical Research Council PR04 (ISRCTN61384873). J Natl Cancer Inst 99:765-776, 2007 (Pubitemid 47073523)
49. Dearnaley DP, Mason MD, Parmar MK, et al: 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 10:872-876, 2009
50. Smith MR, Kabbinavar F, Saad F, et al: Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol 23:2918-2925, 2005 (Pubitemid 46224110)
51. Wirth M, Tammela T, Debruyne F, et al: Effectiveness of Zoledronic acid for the prevention of bone metastases in high-risk prostate cancer patients: A randomised, open label, multicenter study of the European Association of Urology (EAU) in Cooperation with the Scandinavian Prostate Cancer Group (SPCG) and the Arbeitsgemeinschaft Urologische Onkologie (AUO)-A report of the ZEUS study. 2008 Genitourinary Cancers Symposium (abstr 184)
52. Dearnaley DP, Sydes MR, Mason MD, et al: A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PR05 Trial). J Natl Cancer Inst 95:1300- 1311, 2003
53. Small EJ, Smith MR, Seaman JJ, et al: 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 21:4277-4284, 2003 (Pubitemid 46621802)
54. Ernst DS, Tannock IF, Winquist EW, et al: Randomized, double-blind, controlled trial of mitoxantrone/ prednisone and clodronate versus mitoxantrone/ prednisone and placebo in patients with hormone-refractory prostate cancer and pain. J Clin Oncol 21:3335-3342, 2003 (Pubitemid 46613484)
55. 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 94:1458-1468, 2002
56. Saad F, Gleason DM, Murray R, et al: Longterm efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst 96:879-882, 2004 (Pubitemid 38807610)
57. Stopeck AT, Lipton A, Body JJ, 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 28:5132-5139, 2010
58. Henry DH, Costa L, Goldwasser F, et al: 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 29:1125-1132, 2010
59. Hoff AO, Toth BB, Altundag K, et al: Frequency and risk factors associated with osteonecrosis of the jaw in cancer patients treated with intravenous bisphosphonates. J Bone Miner Res 23:826-836, 2008 (Pubitemid 351768801)
60. Advisory Task Force on Bisphosphonate- Related Osteonecrosis of the Jaws, American Association of Oral and Maxillofacial Surgeons: American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg 65:369-376, 2007
61. Nilsson S, Franzeaposn L, Parker C, et al: Bonetargeted radium-223 in symptomatic, hormonerefractory prostate cancer: A randomised, multicentre, placebo-controlled phase II study. Lancet Oncol 8:587- 594, 2007
62. Battistini B, Chailler P, D'Orléans-Juste P, et al: Growth regulatory properties of endothelins. Peptides 14:385-399, 1993
63. Nelson JB, Nguyen SH, Wu-Wong JR, et al: New bone formation in an osteoblastic tumor model is increased by endothelin-1 overexpression and decreased by endothelin A receptor blockade. Urology 53:1063-1069, 1999 (Pubitemid 29196330)
64. Nelson JB, Chan-Tack K, Hedican SP, et al: Endothelin-1 production and decreased endothelin B receptor expression in advanced prostate cancer. Cancer Res 56:663-668, 1996 (Pubitemid 26059878)
65. Nelson JB, Carducci MA: The role of endothelin-1 and endothelin receptor antagonists in prostate cancer. BJU Int 85:45-48, 2000 (suppl 2)
66. James ND, Caty A, Borre M, et al: Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: A double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol 55:1112-1123, 2009
67. James ND, Caty A, Payne H, et al: Final safety and efficacy analysis of the specific endothelin A receptor antagonist zibotentan (ZD4054) in patients with metastatic castration-resistant prostate cancer and bone metastases who were pain-free or mildly symptomatic for pain: A double-blind, placebocontrolled, randomized Phase II trial. BJU Int 106: 966-973, 2010
68. Saad F, Lipton A: SRC kinase inhibition: Targeting bone metastases and tumor growth in prostate and breast cancer. Cancer Treat Rev 36:177-184, 2010
69. Asim M, Siddiqui IA, Hafeez BB, et al: Src kinase potentiates androgen receptor transactivation function and invasion of androgen-independent prostate cancer C4-2 cells. Oncogene 27:3596- 3604, 2008
70. Boyer B, Bourgeois Y, Poupon MF: Src kinase contributes to the metastatic spread of carcinoma cells. Oncogene 21:2347-2356, 2002 (Pubitemid 34407294)
71. Yu EY, Wilding G, Posadas E, et al: Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res 15:7421-7428, 2009
72. Zhang S, Zhau HE, Osunkoya AO, et al: Vascular endothelial growth factor regulates myeloid cell leukemia-1 expression through neuropilin-1- dependent activation of c-MET signaling in human prostate cancer cells. Mol Cancer 9:9, 2010
73. Smith DC, Spira A, De Grève J, et al: Phase 2 study of XL184 in a cohort of patients with castration resistant prostate cancer (CRPC) and measurable soft tissue disease. 22nd European Organisation for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR) Symposium on Molecular Targets and Cancer Therapeutics, Berlin, Germany, November 16-19, 2010