Molecular target therapy for bone metastasis: starting a new era with denosumab, a RANKL inhibitor

Bibliography

• Burgess TL, Qian Y, Kaufman S, et al. The ligand for osteoprotegerin (OPGL) directly activates mature osteoclasts. J Cell Biol 1999;145(3):527-38
   PubMed Web of Science ®Google Scholar
• Joyce JA, Pollard JW. Microenvironmental regulation of metastasis. Nat Rev Cancer 2009;9(4):239-52
   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(5):1082-90
   PubMed Web of Science ®Google Scholar
• Roodman GD. Mechanisms of bone metastasis. N Engl J Med 2004;350(16):1655-64
   PubMed Web of Science ®Google Scholar
• Terpos E, Dimopoulos MA, Berenson J. Established role of bisphosphonate therapy for prevention of skeletal complications from myeloma bone disease. Crit Rev Oncol Hematol 2011;77(Suppl 1):S13-23
   PubMed Web of Science ®Google Scholar
• Lipton A, Uzzo R, Amato RJ, et al. The science and practice of bone health in oncology: managing bone loss and metastasis in patients with solid tumors. J Natl Compr Canc Netw 2009;7(Suppl 7):S1-29; quiz S30
   PubMedGoogle Scholar
• Krupski TL, Smith MR, Lee WC, et al. Natural history of bone complications in men with prostate carcinoma initiating androgen deprivation therapy. Cancer 2004;101(3):541-9
   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
• Carlson RW, Allred DC, Anderson BO, et al. Breast cancer. Clinical practice guidelines in oncology. J Natl Compr Canc Netw 2009;7(2):122-92
   PubMed Web of Science ®Google Scholar
• Hadji P, Gnant M, Aapro M, et al. Dosing of zoledronic acid throughout the treatment continuum in breast cancer. Crit Rev Oncol Hematol 2011;79(2):175-88
   PubMed Web of Science ®Google Scholar
• American Cancer Society. Cancer Facts & Figures. 2008. Available from: http://www.cancer.org/acs/groups/content/@nho/documents/document/2008cafffinalsecuredpdf.pdf [Accessed 13 March 2012]
   Google Scholar
• Theriault RL, Biermann JS, Brown E, et al. NCCN Task Force Report: bone Health and Cancer Care. J Natl Compr Canc Netw 2006;4(Suppl 2):S1-20; quiz S21-2
   PubMedGoogle Scholar
• Torbert JT, Lackman RD. Fractures in the elderly. A guide to practical management. Chapter 2. Pathologic fractures; Springer-Verlag, New York, LLC, 2011
   Google Scholar
• Coleman RE, Rubens RD. The clinical course of bone metastases from breast cancer. Br J Cancer 1987;55(1):61-6
   PubMed Web of Science ®Google Scholar
• Fang K, Peng CF. Predicting the probability of bone metastasis through histological grading of prostate carcinoma: a retrospective correlative analysis of 81 autopsy cases with ante-mortem transurethral resection specimens. J Urol 1983;57:715-20
   Google Scholar
• Coleman RE, Smith P, Rubens RD. Clinical course and prognostic factors following bone recurrence from breast cancer. Br J Cancer 1998;77(2):336-40
   PubMed Web of Science ®Google Scholar
• El Saghir NS, Tfayli A, Hatoum HA, et al. Treatment of metastatic breast cancer: state-of-the-art, subtypes and perspectives. Crit Rev Oncol Hematol 2011;80(3):433-49
   PubMed Web of Science ®Google Scholar
• Mercadante S. Malignant bone pain: pathophysiology and treatment. Pain 1997;69(1-2):1-18
   PubMed Web of Science ®Google Scholar
• Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res 2006;12(20 Pt 2):6243s-9s
   PubMed Web of Science ®Google Scholar
• Hadji P. Clinical considerations for the use of antiresorptive agents in the treatment of metastatic bone disease. Crit Rev Oncol Hematol 2011;80(2):301-13
   PubMed Web of Science ®Google Scholar
• Body JJ, Delmas PD. Urinary pyridinium cross-links as markers of bone resorption in tumor-associated hypercalcemia. J Clin Endocrinol Metab 1992;74(3):471-5
   PubMed Web of Science ®Google Scholar
• Coleman R, Costa L, Saad F, et al. Consensus on the utility of bone markers in the malignant bone disease setting. Crit Rev Oncol Hematol 2011;80(3):411-32
   PubMed Web of Science ®Google Scholar
• Schachar NS. An update on the nonoperative treatment of patients with metastatic bone disease. Clin Orthop Relat Res 2001;382):75-81
   PubMed Web of Science ®Google Scholar
• Bagi CM. Targeting of therapeutic agents to bone to treat metastatic cancer. Adv Drug Deliv Rev 2005;57(7):995-1010
   PubMed Web of Science ®Google Scholar
• Gordon DH. Efficacy and safety of intravenous bisphosphonates for patients with breast cancer metastatic to bone: a review of randomized, double-blind, Phase III trials. Clin Breast Cancer 2005;6(2):125-31
   PubMedGoogle Scholar
• Saad F, Karakiewicz P, Perrotte P. The role of bisphosphonates in hormone-refractory prostate cancer. World J Urol 2005;23(1):14-18
   PubMed Web of Science ®Google Scholar
• Green JR. Bisphosphonates: preclinical review. Oncologist 2004;9 Suppl 4:3-13
   PubMed Web of Science ®Google Scholar
• Body JJ. Denosumab for the management of bone disease in patients with solid tumors. Expert Rev Anticancer Ther 2012;12(3):307-22
   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(18):2412-24
   PubMed Web of Science ®Google Scholar
• Bucay N, Sarosi I, Dunstan CR, et al. osteoprotegerin-deficient mice develop early onset osteoporosis and arterial calcification. Genes Dev 1998;12(9):1260-8
   PubMed Web of Science ®Google Scholar
• Weiner LM. Fully human therapeutic monoclonal antibodies. J Immunother 2006;29(1):1-9
   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(10):1235-44
   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(23):14363-7
   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(2):182-95
   PubMed Web of Science ®Google Scholar
• Castellano D, Sepulveda JM, Garcia-Escobar I, et al. The role of RANK-ligand inhibition in cancer: the story of denosumab. Oncologist 2011;16(2):136-45
   PubMed Web of Science ®Google Scholar
• Sezer O, Heider U, Jakob C, et al. Human bone marrow myeloma cells express RANKL. J Clin Oncol 2002;20(1):353-4
   PubMed Web of Science ®Google Scholar
• Ferrari-Lacraz S, Ferrari S. Do RANKL inhibitors (denosumab) affect inflammation and immunity? Osteoporos Int 2011;22(2):435-46
   PubMed Web of Science ®Google Scholar
• Australian Public Assessment Report for Denosumab. Department of Health and Ageing Therapeutic Goods Administration 2011 30 November. Available from: http://www.tga.gov.au/pdf/auspar/auspar-xgeva.pdf
   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(35):5132-9
   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(9768):813-22
   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(9):1125-32
   PubMed Web of Science ®Google Scholar
• Henry DH, von Moos R, Hungria V, et al. Delaying skeletal-related events in a randomized Phase III study of denosumab versus zoledronic acid in patients with advanced cancer. ASCO Meeting Abstracts 2010;2010:28(15_suppl):9133
   Google Scholar
• Peddi P, Lopez-Olivo MA, Pratt GF, Suarez-Almazor ME. Denosumab in patients with cancer and skeletal metastases: a systematic review and meta-analysis. Cancer Treat Rev 2013;39(1):97-104
   PubMed Web of Science ®Google Scholar
• Lipton A, Siena S, Rader M, et al. Comparison of denosumab versus zoledronic acid (ZA) for treatment of bone metastases in advanced cancer patients: an integrated analysis of 3 pivotal trials. In: ESMO. Annals of oncology. Oxford University Press,Milan, Italy: 2010
   Google Scholar
• 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. In: ESMO. Annals of Oncology. Oxford University Press; Milan, Italy: 2010
   Google Scholar
• Bruera E, Kim HN. Cancer pain. JAMA 2003;290(18):2476-9
   PubMed Web of Science ®Google Scholar
• Hanks GW. The pharmacological treatment of bone pain. Cancer Surv 1988;7(1):87-101
   PubMedGoogle Scholar
• Sheng H, Shao J, Kirkland SC, et al. Inhibition of human colon cancer cell growth by selective inhibition of cyclooxygenase-2. J Clin Invest 1997;99(9):2254-9
   PubMed Web of Science ®Google Scholar
• Sumitani K, Kamijo R, Toyoshima T, et al. Specific inhibition of cyclooxygenase-2 results in inhibition of proliferation of oral cancer cell lines via suppression of prostaglandin E2 production. J Oral Pathol Med 2001;30(1):41-7
   PubMed Web of Science ®Google Scholar
• Manchikanti L, Fellows B, Ailinani H, Pampati V. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician 2010;13(5):401-35
   PubMed Web of Science ®Google Scholar
• Caraceni A, Zecca E, Bonezzi C, et al. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol 2004;22(14):2909-17
   PubMed Web of Science ®Google Scholar
• Caraceni A, Zecca E, Martini C, et al. Gabapentin for breakthrough pain due to bone metastases. Palliat Med 2008;22(4):392-3
   PubMed Web of Science ®Google Scholar
• Lin A, Ray ME. Targeted and systemic radiotherapy in the treatment of bone metastasis. Cancer Metastasis Rev 2006;25(4):669-75
   PubMed Web of Science ®Google Scholar
• Tong D, Gillick L, Hendrickson FR. The palliation of symptomatic osseous metastases: final results of the Study by the Radiation Therapy Oncology Group. Cancer 1982;50(5):893-9
   PubMed Web of Science ®Google Scholar
• Smith H, Navani A, Fishman SM. Radiopharmaceuticals for palliation of painful osseous metastases. Am J Hosp Palliat Care 2004;21(4):303-13
   PubMedGoogle Scholar
• Cheetham PJ, Petrylak DP. Alpha particles as radiopharmaceuticals in the treatment of bone metastases: mechanism of action of radium-223 chloride (Alpharadin) and radiation protection. Oncology (Williston Park) 2012;26(4):330-7; 41
   PubMed Web of Science ®Google Scholar
• Smith HS. Painful osseous metastases. Pain Physician 2011;14(4):E373-403
   PubMed Web of Science ®Google Scholar
• Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013;369(3):213-23
   PubMed Web of Science ®Google Scholar
• NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Breast Cancer. Version 1 2012. Available from: http://www.nccn.org
   Google Scholar
• NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline). Prostate Cancer. Version 3 2012. Available from: http://www.nccn.org
   Google Scholar
• NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Non-Small Cell Lung Cancer. Version 3 2012. Available from: http://www.nccn.org
   Google Scholar
• Cassinello J, González del Alba A, Rivera F, Martín E. SEOM guidelines for the treatment of bone metastases from solid tumours. Clin Transl Oncol 2012;14(7):505-11
   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 III, randomised, placebo-controlled trial. Lancet 2012;379(9810):39-46
   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(2):117-21
   PubMedGoogle Scholar
• Xgeva. Summary of product characteristics. European Medicines Agency Science Medicines Health. 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002173/WC500110381.pdf
   Google Scholar