Role of denosumab in breast cancer

Bibliography

• American Cancer Society Facts and Figures 2007. Avaiable from: http://www.cancer.org/docroot/STT/STT_0.asp [Last accessed 3 July 2009]
   Google Scholar
• World Health Organization Facts and Figures. Avaiable from: http://www.who.int/whr/2003/en/Facts_and_Figures-en.pdf [Last accessed 3 July 2009]
   Google Scholar
• Faneyte IF, Peterse JL Van Tinteren H, et al. Predicting early failure after adjuvant chemotherapy in high-risk breast cancer patients with extensive lymph node involvement. Clin Cancer Res 2004;10:4457-63
   PubMed Web of Science ®Google Scholar
• Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER2/neu oncogene. Science (Wash DC) 1987;235:177-82
   PubMed Web of Science ®Google Scholar
• Paik S, Hazan R, Fisher ER, et al. Pathologic finding from the National Surgical Adjuvant Breast and Bowel Project: prognostic significance of erbB-2 protein expression in primary breast cancer. J Clin Oncol 1990;8:103-12
   PubMed Web of Science ®Google Scholar
• Kallioniemi OP, Holli K, Visakorpi T, et al. Association of c-erbB-2 protein over-expression with high rate of cell proliferation, increased risk of visceral metastasis and poor long-term survival in breast cancer. Int J Cancer 1991;4:650-5
   Google Scholar
• Ross JS, Fletcher JA, Linette GP. The HER-2/neu gene and protein in breast cancer 2003: biomarker and target of therapy. Oncologist 2003;8:307-25
   PubMed Web of Science ®Google Scholar
• Sørlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci 2001;98:10869-74
   PubMed Web of Science ®Google Scholar
• van't Veer LJ, Dai H, van de Vijver MJ, et al. Gene expression profiling predicts clinical outcome of breast cancer. Nature 2002;415:530-6
   PubMed Web of Science ®Google Scholar
• van de Vijver MJ, He YD, van't Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med 2002;347:1999-2009
   PubMed Web of Science ®Google Scholar
• Solomayer EF, Diel IJ, Meyberg GC, et al. Metastatic breast cancer: clinical course, prognosis and therapy related to the first site of metastasis. Breast Cancer Res Treat 2000;59:271-8
   PubMed Web of Science ®Google Scholar
• Coleman RE. Skeletal complications of malignancy. Cancer 1997;80:1588-94
   PubMed Web of Science ®Google Scholar
• Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer 2002;2:584-93
   PubMed Web of Science ®Google Scholar
• Beslija S, Bonneterre J, Burstein H, et al. Second consensus on medical treatment of metastatic breast cancer. Ann Oncol 2007;18:215-55
   PubMed Web of Science ®Google Scholar
• Brown JE, Thomson CS, Ellis SP, et al. Bone resorption predicts for skeletal complications in metastatic bone disease. Br J Cancer 2003;89:2031-7
   PubMed Web of Science ®Google Scholar
• Saad F, Lipton A. Clinical benefits and considerations of bisphosphonate treatment in metastatic bone disease. Semin Oncol 2007;34(6 Suppl 4):17S-23S
   PubMed Web of Science ®Google Scholar
• Cascinu S, Graziano F, Alessandoni P, et al. Different doses of pamidronate in patients with painful osteolytic bone metastases. Support Care Cancer 1998;6:139-43
   PubMed Web of Science ®Google Scholar
• Smith MR. Zoledronic acid to prevent skeletal complications in cancer: corroborating the evidence. Cancer Treat Rev 2005;31(Suppl 3):19S-25S
   PubMedGoogle Scholar
• Bell R. Efficacy of ibandronate in metastatic bone disease: review of clinical data. Oncologist 2005;10(Suppl 1):8S-13S
   PubMed Web of Science ®Google Scholar
• Winter MC, Holen I, Coleman RE. Exploring the anti-tumour activity of bisphosphonates in early breast cancer. Cancer Treat Rev 2008;34:452-75
   Google Scholar
• Gnant M, Mlineritsch B, Schippinger W, et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med 2009;360:679-91
   PubMed Web of Science ®Google Scholar
• Eidtmann H, Bundred NJ, Deboer R, et al. The effect of zoledronic acid on aromatase inhibitor associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36 months follow up of ZO-FAST. Cancer Res 2009;60(Suppl 2):74S
   Google Scholar
• Vega D, Maalouf NM, Sakhaee K. The role of receptor activator of nuclear factor-kappaB (RANK)/RANK ligand/osteoprotegerin: clinical implications. J Clin Endocrinol Metab 2007;92:4514-21
   PubMed Web of Science ®Google Scholar
• Teitelbaum SL. Bone resorption by osteoclasts. Science 2000;289:1504-8
   PubMed Web of Science ®Google Scholar
• Massey HM, Flanagan AM. Human osteoclasts derive from CD14-positive monocytes. Br J Haematol 1999;106:167-70
   PubMed Web of Science ®Google Scholar
• Li P, Schwarz EM, O'Keefe RJ, et al. Systemic tumor necrosis factor alpha mediates an increase in peripheral CD11bhigh osteoclast precursors in tumor necrosis factor alpha-transgenic mice. Arthritis Rheum 2004;50:265-76
   PubMed Web of Science ®Google Scholar
• Demulder A, Takahashi S, Singer FR, et al. Abnormalities in osteoclast precursors and marrow accessory cells in Paget's disease. Endocrinology 1993;133:1978-82
   PubMed Web of Science ®Google Scholar
• Gregoretti MG, Bergui L, Aragno M, et al. Osteoclast precursors circulate in the peripheral blood of patients with aggressive multiple myeloma. Leukemia 1995;9:1392-7
   PubMed Web of Science ®Google Scholar
• Terpos E, Dimopoulos MA. Myeloma bone disease: pathopysiology and management. Ann Oncol 2005;16:1223-31
   PubMed Web of Science ®Google Scholar
• Terpos E, Efstathiou E, Christoulas D, et al. RANKL inhibition: clinical implications for the management of patients with multiple myeloma and solid tumors with bone metastases. Expert Opin Biol Ther 2009;9:465-79
   PubMed Web of Science ®Google Scholar
• Suda T, Takahashi N, Udagawa N, et al. Modulation of osteoclast differentiation and function by the new members of the tumor necrosis factor receptor and ligand families. Endocr Rev 1999;20:345-57
   PubMed Web of Science ®Google Scholar
• Lam J, Takeshita S, Barker JE, et al. TNF-alpha induces osteoclastogenesis by direct stimulation of macrophages exposed to permissive levels of RANK ligand. J Clin Invest 2000;106:1481-8
   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
• Nakagawa N, Kinosaki M, Yamaguchi K, et al. RANK is the essential signaling receptor for osteoclast differentiation factor in osteoclastogenesis. Biochem Biophys Res Commun 1998;253:395-400
   PubMed Web of Science ®Google Scholar
• Hofbauer LC, Heufelder AE. The role of osteoprotegerin and receptor activator of nuclear factor kappaB ligand in the pathogenesis and treatment of rheumatoid arthritis. Arthritis Rheum 2001;44:253-9
   PubMed Web of Science ®Google Scholar
• Ritchlin CT, Haas-Smith SA, Li P, et al. Mechanisms of TNF-alpha– and RANKL-mediated osteoclastogenesis and bone resorption in psoriatic arthritis. J Clin Invest 2003;111:821-31
   PubMed Web of Science ®Google Scholar
• Giuliano N, Colla S, Rizzoli V. Update on the pathogenesis of osteolysis in multiple myeloma patients. Acta Biomed 2004;75:143-52
   PubMedGoogle Scholar
• Orr FW, Varani J, Gondek MD, et al. Chemotactic responses of tumor cells to products of resorbing bone. Science 1979;203:176-9
   PubMed Web of Science ®Google Scholar
• Kostenuik PJ, Singh G, Suyama KL, Orr FW. A quantitative model for spontaneous bone metastasis: evidence for a mitogenic effect of bone on Walker 256 cancer cells. Clin Exp Metastasis 1992;10:403-10
   PubMed Web of Science ®Google Scholar
• Galasko C. Mechanisms of bone destruction in the development of skeletal metastases. Nature 1976;263:507-9
   PubMed Web of Science ®Google Scholar
• Brown JM, Corey E, Lee ZD, et al. Osteoprotegerin and RANK ligand expression in prostate cancer. Urology 2001;57:611-6
   PubMed Web of Science ®Google Scholar
• Zhang J, Dai J, Qi Y, et al. Osteoprotegerin inhibits prostate cancer-induced osteoclastogenesis and prevents prostate tumor growth in the bone. J Clin Invest 2001;107:1235-44
   Google Scholar
• Farrugia AN, Atkins GJ, To LB, et al. Receptor activator of nuclear factor-kappaB ligand expression by human myeloma cells mediates osteoclast formation in vitro and correlates with bone destruction in vivo. Cancer Res 2003;63:5438-45
   PubMed Web of Science ®Google Scholar
• Lai F, Cole-Sinclair M, Cheng WJ, et al. Myeloma cells can directly contribute to the pool of RANKL in bone bypassing the classic stromal and osteoblast pathway of osteoclast stimulation. Brit J Haematol 2004;126:192-201
   PubMed Web of Science ®Google Scholar
• Thomas RJ, Guise TA, Yin JJ, et al. Breast cancer cells interact with osteoblasts to support osteoclast formation. Endocrinology 1999;140:4451-8
   PubMed Web of Science ®Google Scholar
• Chikatsu N, Takeuchi Y, Tamura Y, et al. Interactions between cancer and bone marrow cells induce osteoclast differentiation factor expression and osteoclast-like cell formation in vitro. Biochem Biophys Res Commun 2000;267:632-7
   PubMed Web of Science ®Google Scholar
• Kitazawa S, Kitazawa R. RANK ligand is a prerequisite for cancer-associated osteolytic lesions. J Pathol 2002;198:228-36
   PubMed Web of Science ®Google Scholar
• Okada T, Akikusa S, Okuno H, Kodaka M. Bone marrow metastatic myeloma cells promote osteoclastogenesis through RANKL on endothelial cells. Clin Exp Metastasis 2003;20:639-46
   PubMed Web of Science ®Google Scholar
• Kearns AE, Khosla S, Kostenuik PJ. Receptor activator of nuclear factor kappaB ligand and osteoprotegerin regulation of bone remodeling in health and disease. Endocr Rev 2007;29:155-92
   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
• 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;97:887-92
   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 2005;19:1059-66
   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
• Green LL. Antibody engineering via genetic engineering of the mouse: XenoMouse strains are a vehicle for the faclie generation of therapeutic human monoclonal antibodies. J Immunol Methods 1999;231:11-23
   PubMed Web of Science ®Google Scholar
• Kostenuik PJ, Warmington K, Grisanti M, et al. RANKL inhibition with AMG162, a fully human MAb, causes sustained suppression of bone resorption and increased BMD in knockin mice expressing humanized RANKL. J Bone Miner Res 2005;20:259S
   Web of Science ®Google Scholar
• Atkinson J, Cranmer P, Saunders T, et al. AMG 162, a fully human RANKL antibody, increases bone mass and bone strength in cynomolgus monkeys. J Bone Miner Res 2005;20:294S
   PubMed Web of Science ®Google Scholar
• Ominsky MS, Schroeder J, Smith SY, et al. Denosumab (AMG 162, a fully human RANKL antibody) increases cortical and cancellous bone mass in aged ovariectomized cynomolgus monkeys. J Bone Miner Res 2006;21:72S
   Web of Science ®Google Scholar
• Schwarz EM, Ritchlin CT. Clinical development of anti-RANKL therapy. Arthritis Res Ther 2007;9(Suppl 1):7S
   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 Cancer Res 2006;12:1221-8
   PubMed Web of Science ®Google Scholar
• Yonemor K, Fujiwara Y, Minami H, et al. Phase I 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
• 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;19:1959-66
   Google Scholar
• Peterson MC, Jang G, Kim W, et al. Selection of a phase 3 dose regimen for denosumab based on pharmacokinetic (PK), pharmacodynamic (PD), and safety data from multiple subcutaneous (SC) dosing regimens in breast cancer patients (pts) with bone metastases (BM). J Clin Oncol 2006;24(Suppl 18):abstract 3086
   Google Scholar
• McClung MR, Lewiecki EM, Cohen SB, et al. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006;354:821-31
   PubMed Web of Science ®Google Scholar
• Lipton A, Steger GG, Figuera 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
• Lane NE, Iannini M, Atkins C, et al. RANKL inhibition with denosumab decreases markers of bone and cartilage turnover in patients with rheumatoid arthritis. Arthritis Rheum 2006;54:225S
   Google Scholar
• Lipton A, Steger GG, Figuera J, et al. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res 2008;14:6690-6
   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
• 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
• ClinicalTrials. NCT00556374. Avaiable from: http://www.clinicaltrial.gov/ [Last accessed 3 July 2009]
   Google Scholar
• Allen MR, Iwata K, Phipps R, et al. Alterations in canine vertebral bone turnover, microdamage accumulation, and biomechanical properties following 1-year treatment with clinical treatment doses of risedronate or alendronate. Bone 2006;39:872-9
   PubMed Web of Science ®Google Scholar
• Flick LM, Weaver JM, Ulrich-Vinther M, et al. Effects of receptor activator of NFkappaB (RANK) signaling blockade on fracture healing. J Orthop Res 2003;21:676-84
   PubMed Web of Science ®Google Scholar
• Wong BR, Rho J, Arron J, et al. TRANCE is a novel ligand of the tumor necrosis factor receptor family that activates c-Jun N-terminal kinase in T cells. J Biol Chem 1997;272:25190-4
   PubMed Web of Science ®Google Scholar
• Dougall WC, Glaccum M, Charrier K, et al. RANK is essential for osteoclast and lymph node development. Genes Dev 1999;13:2412-24
   PubMed Web of Science ®Google Scholar
• Kong YY, Yoshida H, Sarosi I, et al. OPGL is a key regulator of osteoclastogenesis, lymphocyte development and lymph-node organogenesis. Nature 1999;397:315-23
   PubMed Web of Science ®Google Scholar
• Yun TJ, Tallquist MD, Aicher A, et al. Osteoprotegerin, a crucial regulator of bone metabolism, also regulates B cell development and function. J Immunol 2001;166:1482-91
   PubMed Web of Science ®Google Scholar
• Stolina M, Guo J, Faggioni R, et al. Regulatory effects of osteoprotegerin on cellular and humoral immune responses. Clin Immunol 2003;109:347-54
   PubMed Web of Science ®Google Scholar
• Miller RE, Branstetter D, Armstrong A, et al. Receptor activator of NF-kappaB ligand inhibition suppresses bone resorption and hypercalcemia but does not affect host immune response to influenza infection. J Immunol 2007;179:266-74
   PubMed Web of Science ®Google Scholar
• Woo SB, Hellstein JW, Kalmar JR. Systematic review: bisphosphonates and osteonecrosis of the jaws. Ann Intern Med 2006;144:753-61
   PubMed Web of Science ®Google Scholar