Denosumab for the prevention of skeletal-related events in patients with bone metastasis from solid tumor

Pharmacotherapy

Volumn 32, Issue 3, 2012, Pages 274-284

  Iranikhah, Maryam ^a   Wilborn, Teresa W ^a   Wensel, Terri M ^a   Ferrell, Jodi B ^a  

^a SAMFORD UNIVERSITY   (United States)

Author keywords

Bone metastases; Denosumab; RANK ligand inhibitor; Skeletal related event

Indexed keywords

ANTINEOPLASTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; CALCIUM; CREATININE; DENOSUMAB; DOXORUBICIN; METHOTREXATE; PAMIDRONIC ACID; TAMOXIFEN; VINBLASTINE; VITAMIN D; ZOLEDRONIC ACID;

ANEMIA; ARTHRALGIA; ASTHENIA; BACKACHE; BONE DISEASE; BONE METASTASIS; BONE PAIN; BONE TURNOVER; BREAST CANCER; CANCER PROGNOSIS; CANCER SURVIVAL; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE COURSE; DRUG CLEARANCE; DRUG CONTRAINDICATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ELIMINATION; DRUG FEVER; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FLU LIKE SYNDROME; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERGLYCEMIA; HYPOCALCEMIA; HYPOPHOSPHATEMIA; INFECTION; JAW OSTEONECROSIS; KIDNEY INJURY; LEUKOPENIA; MAXIMUM PLASMA CONCENTRATION; MULTIPLE MYELOMA; MYALGIA; NAUSEA; NEPHROTOXICITY; OVERALL SURVIVAL; PATHOPHYSIOLOGY; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REVIEW; RISK ASSESSMENT; SINGLE DRUG DOSE; SOLID TUMOR; SURVIVAL RATE; SURVIVAL TIME; VITAMIN SUPPLEMENTATION;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; BONE NEOPLASMS; FRACTURES, BONE; HUMANS; PAIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RANK LIGAND;

EID: 84864611213     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1875-9114.2011.01092.x     Document Type: Review

References (46)

1. American Cancer Society. Cancer facts and figures 2010. Atlanta, GA: American Cancer Society, 2010. Available from http://www.cancer.org/acs/groups/ content/@epidemiologysurveilance/documents/document/acspc-026238.pdf. Accessed March 31, 2011.
2. Bottiglieri S, Adams V. Pharmacologic prevention of skeletalrelated events in cancer patients. Orthopedics 2010;33:577-80.
3. Saad F, Lipton A, Cook R, Chen Y, Smith M, Coleman R. Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer 2007;110:1860-7.
4. Lipton A. Bones, breasts, and bisphosphonates: Rationale for the use of zoledronic acid in advanced and early breast cancer. Breast Cancer: Targets Therapy 2011;3:1-7.
5. Jensen A, Jacobsen JB, Norgaard M, Yong M, Fryzek J, Sorensen HT. Incidence of bone metastases and skeletal-related events in breast cancer patients: A population-based cohort study in Denmark. BMC Cancer 2011;11:1-6.
6. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology. Available from http://www. nccn.org/professionals/physician-gls/f- guidelines.asp. Accessed March 31, 2011.
7. 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.
8. 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, doubleblind study. J Clin Oncol 2010;28:5132-9.
9. Amgen Inc. Xgeva (denosumab) package insert. Thousand Oaks, CA; November 2010. Available from www.Xgeva.com. Accessed March 31, 2011.
10. Psaila B, Lyden D. The metastatic niche: Adapting the foreign soil. Nat Rev Cancer 2010;9:285-93.
11. Bringhurst FR, Demay MB, Krane SM, Kronenberg HM. Bone and mineral metabolism in health and disease. In: Fauci AS, Braunwald E, Kasper DL, et al., eds. Harrison's principles of internal medicine, 17 ed. New York: McGraw Hill, 2008:2365-8.
12. Teitelbaum SL, Ross FP. Genetic regulation of osteoclast development and function. Nat Rev Genet 2003;4:638-49.
13. Bussard KM, Gay CV, Mastro AM. The bone microenvironment in metastasis: What is special about bone? Cancer Metastasis Rev 2008;27:41-55.
14. Mundy GR. Metastasis to bone: Causes, consequences and therapeutic opportunities. Nat Rev Cancer 2002;2:584-93.
15. Liao J, McCauley LK. Skeletal metastasis: Established and emerging roles of parathyroid hormone related protein (PTHrP). Cancer Metastasis Rev 2006;25:559-71.
16. Guise TA, Chirgwin JM. Transforming growth factor-beta in osteolytic breast cancer bone metastases. Clin Orthop Relat Res 2003;415(suppl):S32-8.
17. Yin JJ, Mohammad KS, Käkönen SM, et al. A causal role for endothelin-1 in the pathogenesis of osteoblastic bone metastases. Proc Natl Acad Sci USA 2003;100:10954-9.
18. Clines GA, Mohammad KS, Bao Y, et al. Dickkopf homolog 1 mediates endothelin-1-stimulated new bone formation. Mol Endocrinol 2007;21:486-98.
19. Lee RJ, Saylor PJ, Smith MR. Treatment and prevention of bone complications from prostate cancer. Bone 2011;48:88-95.
20. Samford University Clinical Pharmacology Web Site. Zoledronic acid. Available from http://cpip.gsm.com.ezproxy.samford. edu/. Accessed March 18, 2011.
21. Baron R, Ferrari S, Russell RG. Denosumab and bisphosphonates: Different mechanisms of action and effects. Bone 2011;48:677-92.
22. Kavanagh KL, Guo K, Dunford JE, et al. The molecular mechanism of nitrogen-containing bisphosphonates as antiosteoporosis drugs. Proc Natl Acad Sci USA 2006;103:7829-34.
23. Guise TA. Antitumor effects of bisphosphonates: Promising preclinical evidence. Cancer Treat Rev 2008;34(suppl 1):S19-24.
24. Gnant M. Bisphosphonates in the adjuvant treatment of breast cancer: Rationale and clinical data. Clin Invest 2011;1:97-107.
25. Grey A, Bolland M, Wattie D, Horne A, Gamble G, Reid IR. Prolonged antiresorptive activity of zoledronate: A randomized, controlled trial. JBMR 2010;25:2251-5.
26. Coleman R. Bisphosphonates and other osteoclast inhibitors in patients with metastatic cancer. In: Gralow JF, Savarese DMF, eds. UpToDate. Waltham, MA: UpToDate, 2011. Available from http://www.uptodate.com/contents/ bisphosphonates-andother-osteoclast-inhibitors-in-patients-with-metastatic- cancer?source=search-result&selectedTitle=3%7E150. Accessed March 12, 2011.
27. McClung MR, Lewiecki EM, Cohen SB, et al. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006;352:821-31.
28. Santini D, Perrone G, Roato I, et al. Expression pattern of receptor activator of NFjB (RANK) in a series of primary solid tumors and related bone metastases. J Cell Physiol 2011;226:780-4.
29. Jones DH, Nakashima T, Sanchez OH, et al. Regulation of cancer cell migration and bone metastasis by RANKL. Nature 2006;440:692-6.
30. Zhang J, Dai J, Yao Z, Lu Y, Dougall W, Keller ET. Soluble receptor activator of nuclear factor kappaB Fc diminishes prostate cancer progression in bone. Cancer Res 2003;63: 7883-90.
31. Corey E, Brown LG, Kiefer JA, et al. Osteoprotegerin in prostate cancer bone metastasis. Cancer Res 2005;65:1710-18.
32. Canon JR, Roudier M, Bryant R, et al. Inhibition of RANKL blocks skeletal tumor progression and improves survival in a mouse model of breast cancer bone metastasis. Clin Exp Metastasis 2008;25:119-29.
33. Amgen. A randomized, double-blind, placebo-controlled, multi-center phase 3 study of denosumab as adjuvant treatment for women with early-stage breast cancer at high risk of recurrence (D-CARE). ClinicalTrials.gov. Bethesda, MD: National Library of Medicine. Available from http://clinicaltrials. gov/ct2/show/NCT01077154. Accessed March 5, 2011.
34. 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. Bone Miner Res 2009;24:182-95.
35. Jamal SA, Ljunggren O, Stehman-Breen C, et al. Effects of denosumab on fracture and bone mineral density by level of kidney function. J Bone Miner Res 2011;26:1829-35.
36. Miller PD, Bolognese MA, Lewiecki EM, et al. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: A randomized blinded phase 2 clinical trial. Bone 2008;43:222-9.
37. 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 randomized, doubleblind study. Lancet 2011;377:813-22.
38. 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.
39. 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.
40. 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.
41. Novartis Pharmaceuticals Corporation. Aredia (pamidronate disodium) package insert. East Hanover, NJ; November 2008.
42. Clinical Pharmacology. Pamidronate. Available from http:// clinicalpharmacology-ip.com.ezproxy.samford.edu/. Accessed March 4, 2011.
43. Lexi-Comp. Zometa. Available from http://www.crlonline.com. ezproxy.samford.edu/crlsql/servlet/crlonline. Accessed March 4, 2011.
44. Novartis Pharmaceuticals Corporation. Zometa (zoledronic acid) package insert. East Hanover, NJ: 2011.
45. Novartis Pharmaceuticals Corporation. Reclast (zoledronic acid monohydrate) package insert. East Hanover, NJ: 2011.
46. Red Book online. Denosumab. Greenwood Village, CO: Thompson-Reuters. Available from: Http://www.Thompsonhc.com. ezproxy.samford.edu/micromedex2/ librarian/. Updated March 3, 2011; Accessed January 24, 2012