A comprehensive review of denosumab for bone metastasis in patients with solid tumors

References

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin 2015;65:5-29
   PubMed Web of Science ®Google Scholar
• Coleman RE. Skeletal complications of malignancy. Cancer 1997;80(8 Suppl):1588-94
   PubMed Web of Science ®Google Scholar
• Langer C, Hirsh V. Skeletal morbidity in lung cancer patients with bone metastases: demonstrating the need for early diagnosis and treatment with bisphosphonates. Lung Cancer 2010;67:4-11
   PubMed Web of Science ®Google Scholar
• Coleman RE, Rubens RD. The clinical course of bone metastases from breast cancer. Br J Cancer 1987;55:61-6
   PubMed Web of Science ®Google Scholar
• Reed SD, Radeva JI, Glendenning GA, et al. Cost-effectiveness of zoledronic acid for the prevention of skeletal complications in patients with prostate cancer. J Urol 2004;171:1537-42
   PubMed Web of Science ®Google Scholar
• Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 2001;27:165-76
   PubMed Web of Science ®Google Scholar
• Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Canc Res 2006;12(20 Pt 2):6243-9s
   PubMed Web of Science ®Google Scholar
• Yong M, Jensen AO, Jacobsen JB, et al. Survival in breast cancer patients with bone metastases and skeletal-related events: a population-based cohort study in Denmark (1999–2007). Breast Cancer Res Treat 2011;129:495-503
   PubMed Web of Science ®Google Scholar
• Cetin K, Christiansen CF, Jacobsen JB, et al. Bone metastasis, skeletal-related events, and mortality in lung cancer patients: a Danish population-based cohort study. Lung Cancer 2014;86:247-54
   PubMed Web of Science ®Google Scholar
• Schulman KL, Kohles J. Economic burden of metastatic bone disease in the U.S. Cancer 2007;109:2334-42
   PubMed Web of Science ®Google Scholar
• Boyle WJ, Simonet WS, Lacey DL. Osteoclast differentiation and activation. Nature 2003;423:337-42
   PubMed Web of Science ®Google Scholar
• Body JJ, Greipp P, Coleman RE, et al. A phase I study of AMGN-0007, a recombinant osteoprotegerin construct, in patients with multiple myeloma or breast carcinoma related bone metastases. Cancer 2003;97(3 Suppl):887-92
   PubMed Web of Science ®Google Scholar
• Van Poznak CH, Temin S, Yee GC, et al. American Society of Clinical Oncology executive summary of the clinical practice guideline update on the role of bone-modifying agents in metastatic breast cancer. J Clin Oncol 2011;29:1221-7
   PubMed Web of Science ®Google Scholar
• Van Poznak CH, Von Roenn JH, Temin S. American society of clinical oncology clinical practice guideline update: recommendations on the role of bone-modifying agents in metastatic breast cancer. J Oncol Pract 2011;7:117-21
   PubMedGoogle Scholar
• Robbins JA, Schott AM, Garnero P, et al. Risk factors for hip fracture in women with high BMD: EPIDOS study. Osteoporos Int 2005;16:149-54
   PubMed Web of Science ®Google Scholar
• Dufresne TE, Chmielewski PA, Manhart MD, et al. Risedronate preserves bone architecture in early postmenopausal women in 1 year as measured by three-dimensional microcomputed tomography. Calcif Tissue Int 2003;73:423-32
   PubMed Web of Science ®Google Scholar
• Kostenuik PJ, Nguyen HQ, McCabe J, et al. 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;24:182-95
   PubMed Web of Science ®Google Scholar
• Muir VJ, Scott LJ. Denosumab: in cancer treatment-induced bone loss. BioDrugs 2010;24:379-86
   PubMed Web of Science ®Google Scholar
• Kostenuik PJ. Osteoprotegerin and RANKL regulate bone resorption, density, geometry and strength. Curr Opin Pharmacol 2005;5:618-25
   PubMed Web of Science ®Google Scholar
• Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009;361:756-65
   PubMed Web of Science ®Google Scholar
• Bone HG, Chapurlat R, Brandi ML, et al. The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension. J Clin Endocrinol Metabol 2013;98:4483-92
   PubMed Web of Science ®Google Scholar
• Bekker PJ, Holloway D, Nakanishi A, et al. The effect of a single dose of osteoprotegerin in postmenopausal women. J Bone Miner Res 2001;16:348-60
   PubMed Web of Science ®Google Scholar
• Simonet WS, Lacey DL, Dunstan CR, et al. Osteoprotegerin: a novel secreted protein involved in the regulation of bone density. Cell 1997;89:309-19
   PubMed Web of Science ®Google Scholar
• Tabrizi MA, Tseng CM, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discovery Today 2006;11:81-8
   PubMed Web of Science ®Google Scholar
• Emery JG, McDonnell P, Burke MB, et al. Osteoprotegerin is a receptor for the cytotoxic ligand TRAIL. J Biol Chem 1998;273:14363-7
   PubMed Web of Science ®Google Scholar
• 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 2004;19:1059-66
   PubMed Web of Science ®Google Scholar
• Body JJ, Facon T, Coleman RE, et al. 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 Canc Res 2006;12:1221-8
   PubMed Web of Science ®Google Scholar
• Gibiansky L, Sutjandra L, Doshi S, et al. Population pharmacokinetic analysis of denosumab in patients with bone metastases from solid tumours. Clin Pharmacokinet 2012;51:247-60
   PubMedGoogle Scholar
• Baron R, Ferrari S, Russell RG. Denosumab and bisphosphonates: different mechanisms of action and effects. Bone 2011;48:677-92
   PubMed Web of Science ®Google Scholar
• Fizazi K, Lipton A, Mariette X, et al. 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;27:1564-71
   PubMed Web of Science ®Google Scholar
• Lipton A, Steger GG, Figueroa J, et al. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Canc Res 2008;14:6690-6
   PubMed Web of Science ®Google Scholar
• Doshi S, Sutjandra L, Zheng J, et al. Denosumab dose selection for patients with bone metastases from solid tumors. Clin Canc Res 2012;18:2648-57
   PubMed Web of Science ®Google Scholar
• 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;22:679-87
   PubMed Web of Science ®Google Scholar
• Smith MR, Saad F, Coleman R, 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
   PubMed Web of Science ®Google Scholar
• 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 2010;28:5132-9
   PubMed Web of Science ®Google Scholar
• Mould DR, Green B. Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs 2010;24:23-39
   PubMed Web of Science ®Google Scholar
• Lipton A, Steger GG, Figueroa J, et al. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol 2007;25:4431-7
   PubMed Web of Science ®Google Scholar
• Yonemori K, Fujiwara Y, Minami H, et al. Phase 1 trial of denosumab safety, pharmacokinetics, and pharmacodynamics in Japanese women with breast cancer-related bone metastases. Cancer Sci 2008;99:1237-42
   PubMed Web of Science ®Google Scholar
• Lacey DL, Timms E, Tan HL, et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell 1998;93:165-76
   PubMed Web of Science ®Google Scholar
• Lipton A, Theriault RL, Hortobagyi GN, et al. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer 2000;88:1082-90
   PubMed Web of Science ®Google Scholar
• Saad F. Clinical benefit of zoledronic acid for the prevention of skeletal complications in advanced prostate cancer. Clin Prostate Cancer 2005;4:31-7
   PubMedGoogle Scholar
• Hortobagyi GN. Bone metastases in breast cancer patients. Semin Oncol 1991;18(4 Suppl 5):11-15
   PubMedGoogle Scholar
• Martin M, Bell R, Bourgeois H, et al. Bone-related complications and quality of life in advanced breast cancer: results from a randomized phase III trial of denosumab versus zoledronic acid. Clin Canc Res 2012;18:4841-9
   PubMed Web of Science ®Google Scholar
• Cleeland CS, Body JJ, Stopeck A, et al. Pain outcomes in patients with advanced breast cancer and bone metastases: results from a randomized, double-blind study of denosumab and zoledronic acid. Cancer 2013;119:832-8
   PubMed Web of Science ®Google Scholar
• Eastell R. Aromatase inhibitors and bone. J Steroid Biochem Mol Biol 2007;106:157-61
   PubMed Web of Science ®Google Scholar
• Hillner BE, Ingle JN, Chlebowski RT, et al. American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol 2003;21:4042-57
   PubMed Web of Science ®Google Scholar
• Gnant M, Mlineritsch B, Luschin-Ebengreuth G, et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 5-year follow-up of the ABCSG-12 bone-mineral density substudy. Lancet Oncol 2008;9:840-9
   PubMed Web of Science ®Google Scholar
• Gnant M. Role of bisphosphonates in postmenopausal women with breast cancer. Cancer Treat Rev 2014;40:476-84
   PubMed Web of Science ®Google Scholar
• Coleman R, de Boer R, Eidtmann H, et al. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Ann Oncol 2013;24:398-405
   PubMed Web of Science ®Google Scholar
• Brufsky AM, Harker WG, Beck JT, et al. Final 5-year results of Z-FAST trial: adjuvant zoledronic acid maintains bone mass in postmenopausal breast cancer patients receiving letrozole. Cancer 2012;118:1192-201
   PubMed Web of Science ®Google Scholar
• Ellis GK, Bone HG, Chlebowski R, et al. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol 2008;26:4875-82
   PubMed Web of Science ®Google Scholar
• Gnant M, Pfeiler G, Dubsky PC, et al. Adjuvant denosumab in breast cancer (ABCSG-18): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2015;386:433-43
   PubMed Web of Science ®Google Scholar
• Bubendorf L, Schopfer A, Wagner U, et al. Metastatic patterns of prostate cancer: an autopsy study of 1,589 patients. Hum Pathol 2000;31:578-83
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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 2005;97:59-69
   PubMed Web of Science ®Google Scholar
• Smith MR, Martin TJ. Foreword: skeletal complications of cancer. Bone 2011;48:5
   PubMed Web of Science ®Google Scholar
• Gennari L, Nuti R, Bilezikian JP. Aromatase activity and bone homeostasis in men. J Clin Endocrinol Metab 2004;89:5898-907
   PubMed Web of Science ®Google Scholar
• Smith MR, McGovern FJ, Zietman AL, et al. Pamidronate to prevent bone loss during androgen-deprivation therapy for prostate cancer. N Engl J Med 2001;345:948-55
   PubMed Web of Science ®Google Scholar
• Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med 2005;352:154-64
   PubMed Web of Science ®Google Scholar
• 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;94:1458-68
   PubMed Web of Science ®Google Scholar
• 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 2005;23:7897-903
   PubMed Web of Science ®Google Scholar
• Michaelson MD, Kaufman DS, Lee H, et al. 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;25:1038-42
   PubMed Web of Science ®Google Scholar
• Smith MR, Egerdie B, Hernandez Toriz N, et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med 2009;361:745-55
   PubMed Web of Science ®Google Scholar
• 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 2011;29:1125-32
   PubMed Web of Science ®Google Scholar
• Scagliotti GV, Hirsh V, Siena S, et al. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol 2012;7:1823-9
   PubMed Web of Science ®Google Scholar
• Hageman K, Patel KC, Mace K, Cooper MR. The role of denosumab for prevention of skeletal-related complications in multiple myeloma. Ann Pharmacother 2013;47:1069-74
   PubMed Web of Science ®Google Scholar
• Thomas D, Carriere P, Jacobs I. Safety of denosumab in giant-cell tumour of bone. Lancet Oncol 2010;11:815
   PubMed Web of Science ®Google Scholar
• Thomas D, Henshaw R, Skubitz K, et al. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol 2010;11:275-80
   PubMed Web of Science ®Google Scholar
• Chawla S, Henshaw R, Seeger L, et al. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol 2013;14:901-8
   PubMed Web of Science ®Google Scholar
• 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;48:3082-92
   PubMed Web of Science ®Google Scholar
• Brown JP, Prince RL, Deal C, et al. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res 2009;24:153-61
   PubMed Web of Science ®Google Scholar
• Early Breast Cancer Trialists' Collaborative Group. Adjuvant bisphosphonate treatment in early breast cancer: meta-analyses of individual patient data from randomised trials. Lancet 2015;386:1353–61. doi: 10.1016/S0140-6736(15)60908-4
   Google Scholar
• Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE). Available at: https://clinicaltrials.gov/ct2/show/NCT01077154. (Last accessed 18 August 2015)
   Google Scholar
• Cosman F, de Beur SJ, LeBoff MS, et al. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int 2014;25:2359-81
   PubMed Web of Science ®Google Scholar
• Watts NB, Lewiecki EM, Miller PD, Baim S. National Osteoporosis Foundation 2008 Clinician's Guide to Prevention and Treatment of Osteoporosis and the World Health Organization Fracture Risk Assessment Tool (FRAX): what they mean to the bone densitometrist and bone technologist. J Clin Densitom 2008;11:473-7
   PubMed Web of Science ®Google Scholar
• Qi WX, Lin F, He AN, et al. Incidence and risk of denosumab-related hypocalcemia in cancer patients: a systematic review and pooled analysis of randomized controlled studies. Curr Med Res Opin 2013;29:1067-73
   PubMed Web of Science ®Google Scholar
• Amgen Inc. Xgeva (denosumab): full prescribing information. Available at: http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf (Last Accessed 15 August 2015)
   Google Scholar
• 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 2014;19:403-10
   PubMed Web of Science ®Google Scholar
• Henry JM, Morley AA, Sykes PJ. Purging of myeloma cells using all-trans retinoic acid in a mouse model. Exp Hematol 2001;29:315-21
   PubMed Web of Science ®Google Scholar
• Freemantle N, Cooper C, Diez-Perez A, et al. Results of indirect and mixed treatment comparison of fracture efficacy for osteoporosis treatments: a meta-analysis. Osteoporos Int 2013;24:209-17
   PubMed Web of Science ®Google Scholar
• Hiligsmann M, Reginster JY. Potential cost-effectiveness of denosumab for the treatment of postmenopausal osteoporotic women. Bone 2010;47:34-40
   PubMed Web of Science ®Google Scholar
• Hiligsmann M, Reginster JY. Cost effectiveness of denosumab compared with oral bisphosphonates in the treatment of post-menopausal osteoporotic women in Belgium. Pharmacoeconomics 2011;29:895-911
   PubMed Web of Science ®Google Scholar
• Jonsson B, Strom O, Eisman JA, et al. Cost-effectiveness of denosumab for the treatment of postmenopausal osteoporosis. Osteoporos Int 2011;22:967-82
   PubMed Web of Science ®Google Scholar
• Ford J, Cummins E, Sharma P, et al. Systematic review of the clinical effectiveness and cost-effectiveness, and economic evaluation, of denosumab for the treatment of bone metastases from solid tumours. Health Technol Assess 2013;17:1-386
   PubMed Web of Science ®Google Scholar
• Ford JA, Jones R, Elders A, et al. Denosumab for treatment of bone metastases secondary to solid tumours: systematic review and network meta-analysis. Eur J Cancer 2013;49:416-30
   PubMed Web of Science ®Google Scholar