Denosumab for the management of bone disease in patients with solid tumors

Expert Review of Anticancer Therapy

Volumn 12, Issue 3, 2012, Pages 307-322

  Body, Jean Jacques ^a  

^a BRUGMANN UNIVERSITY HOSPITAL   (Belgium)

Author keywords

bone metastases; denosumab; skeletal related events; supportive care; zoledronic acid

Indexed keywords

AMINO TERMINAL TELOPEPTIDE; BISPHOSPHONIC ACID DERIVATIVE; CREATININE; DENOSUMAB; OSTEOCLAST DIFFERENTIATION FACTOR; PAMIDRONIC ACID; PLACEBO; ZOLEDRONIC ACID;

ADVANCED CANCER; ANEMIA; ARTHRALGIA; BACKACHE; BONE DISEASE; BONE LESION; BONE METASTASIS; BONE PAIN; BONE REMODELING; BONE TURNOVER; BREAST ADENOCARCINOMA; BREAST CANCER; CALCIUM BLOOD LEVEL; CANCER PREVENTION; CANCER RISK; CANCER SURVIVAL; CANCER THERAPY; CHILL; CLINICAL EFFECTIVENESS; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; CREATININE URINE LEVEL; DECREASED APPETITE; DOSE RESPONSE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDICATION; DRUG MECHANISM; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEVER; HOT FLUSH; HUMAN; HYPOCALCEMIA; INFECTION; JAW OSTEONECROSIS; KIDNEY DISEASE; LUNG NON SMALL CELL CANCER; MULTIPLE MYELOMA; MYALGIA; NAUSEA; OVERALL SURVIVAL; PATHOLOGIC FRACTURE; PROSTATE CANCER; RADIATION INJURY; REVIEW; RISK REDUCTION; SIDE EFFECT; SINGLE DRUG DOSE; SOLID TUMOR; SPINAL CORD COMPRESSION;

ANTIBODIES, MONOCLONAL; BIOLOGICAL AVAILABILITY; BONE AND BONES; BONE DENSITY CONSERVATION AGENTS; BONE NEOPLASMS; BONE REMODELING; CLINICAL TRIALS AS TOPIC; DIPHOSPHONATES; DISEASE MANAGEMENT; HUMANS; IMIDAZOLES; IMMUNOLOGIC FACTORS; NEOPLASM METASTASIS; NEOPLASMS; OUTCOME ASSESSMENT (HEALTH CARE); PALLIATIVE CARE; RANK LIGAND; RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-KAPPA B;

EID: 84857852442     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.11.204     Document Type: Review

References (73)

1. World Health Organization (WHO). World Cancer Report 2008. International Agency for Research on Cancer, Lyon, France (2008).
2. Brenner H, Francisci S, De Angelis R et al. Long-term survival expectations of cancer patients in Europe in 2000-2002. Eur. J. Cancer 45(6), 1028-1041 (2009).
3. Maddams J, Brewster D, Gavin A et al. Cancer prevalence in the United Kingdom: Estimates for 2008. Br. J. Cancer 101(3), 541-547 (2009).
4. Coleman RE. Metastatic bone disease: Clinical features, pathophysiology and treatment strategies. Cancer Treat. Rev. 27(3), 165-176 (2001).
5. Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin. Cancer Res. 12(20 Pt 2), 6243s-6249s (2006).
6. Domchek SM, Younger J, Finkelstein DM, Seiden MV. Predictors of skeletal complications in patients with metastatic breast carcinoma. Cancer 89(2), 363-368 (2000).
7. Saad F, Lipton A, Cook R, Chen YM, Smith M, Coleman R. Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer 110(8), 1860-1867 (2007).
8. Chia VM, Cetin K, Jacobsen JB et al. The incidence and prognostic significance of bone metastases and skeletal-related events in lung cancer patients: A population-based cohort study in Denmark. J. Clin. Oncol. 28(15 Suppl.) (2010) (Abstract e18074).
9. Norgaard M, Jensen AO, Jacobsen JB, Cetin K, Fryzek JP, Sorensen HT. Skeletal related events, bone metastasis and survival of prostate cancer: A population based cohort study in Denmark (1999 to 2007). J. Urol. 184(1), 162-167 (2010).
10. Schulman KL, Kohles J. Economic burden of metastatic bone disease in the U.S. Cancer 109(11), 2334-2342 (2007).
11. Boyle WJ, Simonet WS, Lacey DL. Osteoclast differentiation and activation. Nature 423(6937), 337-342 (2003).
12. Roodman GD, Dougall WC. RANK ligand as a therapeutic target for bone metastases and multiple myeloma. Cancer Treat. Rev. 34(1), 92-101 (2008).
13. Nakashima T, Hayashi M, Fukunaga T et al. Evidence for osteocyte regulation of bone homeostasis through RANKL expression. Nat. Med. 17(10), 1231-1234 (2011).
14. Xiong J, Onal M, Jilka RL, Weinstein RS, Manolagas SC, O'Brien CA. Matrix-embedded cells control osteoclast formation. Nat. Med. 17(10), 1235-1241 (2011).
15. Lum L, Wong BR, Josien R et al. Evidence for a role of a tumor necrosis factor-alpha (TNF-alpha)-converting enzyme-like protease in shedding of TRANCE, a TNF family member involved in osteoclastogenesis and dendritic cell survival. J. Biol. Chem. 274(19), 13613-13618 (1999).
16. Kingsley LA, Fournier PG, Chirgwin JM, Guise TA. Molecular biology of bone metastasis. Mol. Cancer Ther. 6(10), 2609-2617 (2007).
17. 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. 19(3), 420-432 (2008).
18. 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. 29(9), 1221-1227 (2011).
19. Body JJ. Breast cancer: Bisphosphonate therapy for metastatic bone disease. Clin. Cancer Res. 12(20 Pt 2), 6258s-6263s (2006).
20. Rosen LS, Gordon D, Kaminski M et al. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: A randomized, double-blind, multicenter, comparative trial. Cancer 98(8), 1735-1744 (2003).
21. Kohno N, Aogi K, Minami H et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: A randomized, placebo-controlled trial. J. Clin. Oncol. 23(15), 3314-3321 (2005).
22. 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. 96(11), 879-882 (2004).
23. Saad F. Clinical benefit of zoledronic acid for the prevention of skeletal complications in advanced prostate cancer. Clin. Prostate Cancer 4(1), 31-37 (2005).
24. Rosen LS, Gordon D, Tchekmedyian NS et al. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: A randomized, Phase III, double-blind, placebo-controlled trial. Cancer 100(12), 2613-2621 (2004).
25. Rosen LS, Gordon D, Kaminski M et al. Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: A Phase III, double-blind, comparative trial. Cancer J. 7(5), 377-387 (2001).
26. Rosen LS, Gordon DH, Dugan W Jr. et al. Zoledronic acid is superior to pamidronate for the treatment of bone metastases in breast carcinoma patients with at least one osteolytic lesion. Cancer 100(1), 36-43 (2004).
27. 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. 21(23), 4277-4284 (2003).
28. Neville-Webbe HL, Coleman RE. Bisphosphonates and RANK ligand inhibitors for the treatment and prevention of metastatic bone disease. Eur. J. Cancer 46(7), 1211-1222 (2010).
29. 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(13), 2918-2925 (2005).
30. Gnant M, Mlineritsch B, Schippinger W et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N. Engl. J. Med. 360(7), 679-691 (2009).
31. Baron R, Ferrari S, Russell RG. Denosumab and bisphosphonates: Different mechanisms of action and effects. Bone 48(4), 677-692 (2011).
32. Body JJ. The risk of cumulative renal effects of intravenous bisphosphonates. Support. Cancer Ther. 3(2), 77-83 (2006).
33. Drake MT, Clarke BL, Khosla S. Bisphosphonates: Mechanism of action and role in clinical practice. Mayo Clin. Proc. 83(9), 1032-1045 (2008).
34. Russo A, Bronte G, Rizzo S et al. Anti-endothelin drugs in solid tumors. Expert Opin. Emerg. Drugs 15(1), 27-40 (2010).
35. Nelson J, Bagnato A, Battistini B, Nisen P. The endothelin axis: Emerging role in cancer. Nat. Rev. Cancer 3(2), 110-116 (2003).
36. Bekker PJ, Holloway D, Nakanishi A, Arrighi M, Leese PT, Dunstan CR. The effect of a single dose of osteoprotegerin in postmenopausal women. J. Bone Miner. Res. 16(2), 348-360 (2001).
37. 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 97(3 Suppl.), 887-892 (2003).
38. Lewiecki EM. RANK ligand inhibition with denosumab for the management of osteoporosis. Expert Opin. Biol. Ther. 6(10), 1041-1050 (2006).
39. Fili S, Karalaki M, Schaller B. Therapeutic implications of osteoprotegerin. Cancer Cell Int. 9, 26 (2009).
40. Bone HG, Bolognese MA, Yuen CK et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J. Clin. Endocrinol. Metab. 93(6), 2149-2157 (2008).
41. 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. 24(1), 153-161 (2009).
42. Kendler DL, Roux C, Benhamou CL et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J. Bone Miner. Res. 25(1), 72-81 (2010).
43. Cummings SR, Martin JS, Mcclung MR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N. Engl. J. Med. 361(8), 756-765 (2009).
44. 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. 26(30), 4875-4882 (2008).
45. Smith MR, Egerdie B, Hernandez Toriz N et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N. Engl. J. Med. 361(8), 745-755 (2009).
46. Smith MR, Saad F, Egerdie B et al. Effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer. J. Urol. 182(6), 2670-2675 (2009).
47. 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. 24(2), 182-195 (2009).
48. Muir VJ, Scott LJ. Denosumab: In cancer treatment-induced bone loss. BioDrugs 24(6), 379-386 (2010).
49. 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(7), 1059-1066 (2004).
50. 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. Cancer Res. 12(4), 1221-1228 (2006).
51. Burkiewicz JS, Scarpace SL, Bruce SP. Denosumab in osteoporosis and oncology. Ann. Pharmacother. 43(9), 1445-1455 (2009).
52. 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. 25(28), 4431-4437 (2007).
53. 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. Cancer Res. 14(20), 6690-6696 (2008).
54. 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. 27(10), 1564-1571 (2009).
55. Body JJ, Lipton A, Gralow J et al. Effects of denosumab in patients with bone metastases with and without previous bisphosphonate exposure. J. Bone Miner. Res. 25(3), 440-446 (2010).
56. 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(35), 5132-5139 (2010).
57. Fizazi K, Carducci M, Smith M et al. A randomised, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in men with castration-resistant prostate cancer. Lancet 377(9768), 813-822 (2011).
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(9), 1125-1132 (2011).
59. Lipton A, Siena S, Rader M et al. Comparison of denosumab versus zoledronic acid for treatment of bone metastases in advanced cancer patients: An integrated analysis of 3 pivotal trials. Poster presented at: The 35th Annual Congress of the European Society for Medical Oncology (ESMO). Milan, Italy, 8-12 October 2010 (Abstract 1249P).
60. Cleeland CS, Patrick DL, Fallowfield L et al. Effects of denosumab vs zoledronic acid (ZA) on pain in patients (pts) with advanced cancer and bone metastases: An integrated analysis of 3 pivotal trials. Ann. Oncol. 21(Suppl. 8), viii380 (2010) (Abstract 1248P).
61. Breen TL, Shane E. Prolonged hypocalcemia after treatment with zoledronic acid in a patient with prostate cancer and vitamin D deficiency. J. Clin. Oncol. 22(8), 1531-1532 (2004).
62. Campbell-Baird C, Lipton A, Sarkeshik M, Ma H, Jun S. Incidence of acute phase adverse events following denosumab or intravenous bisphosphonates: Results from a randomized, controlled Phase II study in patients with breast cancer and bone metastases. Comm. Oncol. 7(2), 85-89 (2010).
63. Saad F, Brown JE, Van Poznak C et al. Incidence, risk factors, and outcomes of osteonecrosis of the jaw: Integrated analysis from three blinded active-controlled Phase III trials in cancer patients with bone metastases. Ann. Oncol. doi:10.1093/annonc/mdr435 (2011) (Epub ahead of print).
64. Wilkinson GS, Kuo YF, Freeman JL, Goodwin JS. Intravenous bisphosphonate therapy and inflammatory conditions or surgery of the jaw: A population-based analysis. J. Natl Cancer Inst. 99(13), 1016-1024 (2007).
65. Bamias A, Kastritis E, Bamia C et al. Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: Incidence and risk factors. J. Clin. Oncol. 23(34), 8580-8587 (2005).
66. West H. Denosumab for prevention of skeletal-related events in patients with bone metastases from solid tumors: Incremental benefit, debatable value. J. Clin. Oncol. 29(9), 1095-1098 (2011).
67. Thomas DM, Skubitz KM. Giant cell tumour of bone. Curr. Opin. Oncol. 21(4), 338-344 (2009).
68. Thomas D, Carriere P, Jacobs I. Safety of denosumab in giant-cell tumour of bone. Lancet Oncol. 11(9), 815 (2010).
69. Gonzalez-Suarez E, Jacob AP, Jones J et al. RANK ligand mediates progestin-induced mammary epithelial proliferation and carcinogenesis. Nature 468(7320), 103-107 (2010).
70. Schramek D, Leibbrandt A, Sigl V et al. Osteoclast differentiation factor RANKL controls development of progestin-driven mammary cancer. Nature 468(7320), 98-102 (2010).
71. Ominsky MS, Li C, Li X et al. Inhibition of sclerostin by monoclonal antibody enhances bone healing and improves bone density and strength of nonfractured bones. J. Bone Miner. Res. 26(5), 1012-1021 (2011).
72. Coleman RE, Marshall H, Cameron D et al. Breast-cancer adjuvant therapy with zoledronic acid. N. Engl. J. Med. 365(15), 1396-1405 (2011).
73. 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 doi:10.1016/S0140-6736(11)61226-9 (2011) (Epub ahead of print).