Comparison of the efficacy and safety of denosumab versus bisphosphonates in breast cancer and bone metastases treatment: A meta-analysis of randomized controlled trials

Oncology Letters

Volumn 7, Issue 6, 2014, Pages 1997-2002

  Wang, Xin ^a   Yang, Ke Hu ^a   Wanyan, Pingping ^a   Tian, Jin Hui ^a  

^a LANZHOU UNIVERSITY   (China)

Author keywords

Bisphosphonates; Bone metastases; Breast cancer; Denosumab; Meta analysis

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; DENOSUMAB; IBANDRONIC ACID; OSTEOCLAST DIFFERENTIATION FACTOR; PAMIDRONIC ACID; ZOLEDRONIC ACID;

ACUTE PHASE RESPONSE; ANEMIA; ARTHRALGIA; ARTICLE; BACKACHE; BONE METASTASIS; BONE PAIN; BREAST CANCER; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FATIGUE; FEVER; HEADACHE; HUMAN; INCIDENCE; JAW OSTEONECROSIS; LIMB PAIN; META ANALYSIS; MULTICENTER STUDY (TOPIC); NAUSEA; NEPHROTOXICITY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; QUALITY CONTROL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SURVIVAL TIME; VOMITING;

EID: 84898905618     PISSN: 17921074     EISSN: 17921082     Source Type: Journal    
DOI: 10.3892/ol.2014.1982     Document Type: Article

References (45)

1. Bray F, Jemal A, Grey N, Ferlay J and Forman D: Global cancer transitions according to the Human Development Index (2008-2030): a population-based study. Lancet Oncol 8: 790-801, 2012.
2. Coleman RE: Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res 12: S6243-S6249, 2006.
3. Coleman RE, Lipton A, Roodman GD, Guise TA, Boyce BF, Brufsky AM, Clézardin P, Croucher PI, Gralow JR, Hadji P, et al: Metastasis and bone loss: advancing treatment and prevention. Cancer Treat Rev 36: 615-620, 2010.
4. Coleman RE and Rubens RD: The clinical course of bone metastases from breast cancer. Br J Cancer: 55: 61-66, 1987.
5. Coleman R: Potential use of bisphosphonates in the prevention of metastases in early-stage breast cancer. Clin Breast Cancer 7: S29-S35, 2007.
6. Body JJ: Effectiveness and cost of bisphosphonate therapy in tumor bone disease. Cancer 97: 859-865, 2003.
7. Coleman RE: Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 27: 165-176, 2001.
8. Brown JE, Cook RJ, Major P, Lipton A, Saad F, Smith M, Lee KA, Zheng M, Hei YJ and Coleman RE: Bone turnover markers as predictors of skeletal complications in prostate cancer, lung cancer, and other solid tumors. J Natl Cancer Inst 97: 59-69, 2005.
9. Costa L, Demers LM, Gouveia-Oliveira A, Schaller J, Costa EB, de Moura MC and Lipton A: Prospective evaluation of the peptide-bound collagen type I cross-links N-telopeptide and C-telopeptide in predicting bone metastases status. J Clin Oncol 20: 850-856, 2002.
10. Coleman RE, Major P, Lipton A, Brown JE, Lee KA, Smith M, Saad F, Zheng M, Hei YJ, Seaman J and Cook R: Predictive value of bone resorption and formation markers in cancer patients with bone metastases receiving the bisphosphonate zoledronic acid. J Clin Oncol 23: 4925-4935, 2005.
11. Nørgaard M, Jensen AØ, Jacobsen JB, Cetin K, Fryzek JP and Sørensen HT: Skeletal related events, bone metastasis and survival of prostate cancer: a population based cohort study in Denmark (1999 to 2007). J Urol 184: 162-167, 2010.
12. Sathiakumar N, Delzell E, Morrisey MA, Falkson C, Yong M, Chia V, Blackburn J, Arora T and Kilgore ML: Mortality following bone metastasis and skeletal-related events among men with prostate cancer: a population-based analysis of U.S. Medicare beneficiaries, 1999-2006. Prostate Cancer Prostatic Dis 14: 177-183, 2011.
13. Costa L, Badia X, Chow E, Lipton A and Wardley A: Impact of skeletal complications on patients' quality of life, mobility, and functional independence. Support Care Cancer 16: 879-889, 2008.
14. Costa L and Major PP: Effect of bisphosphonates on pain and quality of life in patients with bone metastases. Nat Clin Pract Oncol 6: 163-174, 2009
15. Pockett RD, Castellano D, McEwan P, Oglesby A, Barber BL and Chung K: The hospital burden of disease associated with bone metastases and skeletal-related events in patients with breast cancer, lung cancer, or prostate cancer in Spain. Eur J Cancer Care (Engl) 19: 755-760, 2010.
16. Oefelein MG, Ricchiuti V, Conrad W and Resnick MI: Skeletal fractures negatively correlate with overall survival in men with prostate cancer. J Urol 168:1005-1007, 2002.
17. Saad F, Lipton A, Cook R, Chen YM, Smith M and Coleman R: Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer 110: 1860-1867, 2007.
18. Weinfurt KP, Castel LD, Li Y, Timbie JW, Glendenning GA and Schulman KA: Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions. Med Care 42: 164-175, 2004.
19. Wardley A, Davidson N, Barrett-Lee P, Hong A, Mansi J, Dodwell D, Murphy R, Mason T and Cameron D: Zoledronic acid significantly improves pain scores and quality of life in breast cancer patients with bone metastases: a randomised, crossover study of community vs hospital bisphosphonate administration. Br J Cancer 92: 1869-1876, 2005.
20. Abrahm JL, Banffy MB and Harris MB: Spinal cord compression in patients with advanced metastatic cancer: "all I care about is walking and living my life." JAMA 299: 937-946, 2008.
21. Theriault RL, Lipton A, Hortobagyi GN, Leff R, Glück S, Stewart JF, Costello S, Kennedy I, Simeone J, Seaman JJ, et al: Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled trial. J Clin Oncol 17: 846-854, 1999.
22. Rosen LS, Gordon D, Tchekmedyian S, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, de Souza P, Zheng M, Urbanowitz G, Reitsma D and Seaman JJ: Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial -the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. J Clin Oncol 21: 3150-3157, 2003.
23. Aapro M, Abrahamsson PA, Body JJ, Coleman RE, Colomer R, Costa L, Crinò L, Dirix L, Gnant M, Gralow J, et al: Guidance on the use of bisphosphonates in solid tumours: recommendations of an international expert panel. Ann Oncol 19: 420-432, 2008.
24. Hillner BE, Ingle JN, Chlebowski RT, Gralow J, Yee GC, Janjan NA, Cauley JA, Blumenstein BA, Albain KS, Lipton A and Brown S; American Society of Clinical Oncology: American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol 21: 4042-4057, 2003.
25. Basch EM, Somerfield MR, Beer TM, Carducci MA, Higano CS, Hussain MH and Scher HI; American Society of Clinical Oncology: American Society of Clinical Oncology endorsement of the Cancer Care Ontario Practice Guideline on nonhormonal therapy for men with metastatic hormone-refractory (castration-resistant) prostate cancer. J Clin Oncol 25: 5313-5318, 2007.
26. Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein MA, Coleman RE, Reitsma DJ, 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: 1735-1744, 2003.
27. Markowitz GS, Fine PL, Stack JI, Kunis CL, Radhakrishnan J, Palecki W, Park J, Nasr SH, Hoh S, Siegel DS and D'Agati VD: Toxic acute tubular necrosis following treatment with zoledronate (Zometa). Kidney Int 64: 281-289, 2003.
28. Perazella MA and Markowitz GS: Bisphosphonate nephrotoxicity. Kidney Int 74: 1385-1393, 2008.
29. Novartis Pharmaceuticals Corporation: Zometa (zoledronic acid) prescribing information. East Hanover, NJ, 2011. http://www.pharma.us.novartis.com/product/pi/pdf/Zometa.pdf. Accessed September 1, 2013.
30. Mauri D, Valachis A, Polyzos IP, Polyzos NP, Kamposioras K and Pesce LL: Osteonecrosis of the jaw and use of bisphosphonates in adjuvant breast cancer treatment: a meta-analysis. Breast Cancer Res Treat 116: 433-439, 2009.
31. Thomas RJ, Guise TA, Yin JJ, Elliott J, Horwood NJ, Martin TJ and Gillespie MT: Breast cancer cells interact with osteoblasts to support osteoclast formation. Endocrinology 140: 4451-4458, 1999.
32. US Food and Drug Administration: Denosumab (Xgeva, Amgen) approval for the prevention of skeletal-related events in patients with bone metastases from solid tumors, 2010. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125320s007ltr.pdf. Accessed November 18, 2010.
33. Serlin RC, Mendoza TR, Nakamura Y, Edwards KR and Cleeland CS: When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain 61: 277-284, 1995.
34. Higgins JPT and Green S (eds.): Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane-handbook.org. Accessed March 12, 2011.
35. Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, et al: Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res 14: 6690-6696, 2008.
36. Body JJ, Facon T, Coleman RE, Lipton A, Geurs F, Fan M, Holloway D, Peterson MC and Bekker PJ: 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: 1221-1228, 2006.
37. Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, 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: 5132-5139, 2010.
38. Martin M, Bell R, Bourgeois H, Brufsky A, Diel I, Eniu A, Fallowfield L, Fujiwara Y, Jassem J, Paterson AH, 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 Cancer Res 18: 4841-4849, 2012.
39. Cleeland CS, Body JJ, Stopeck A, von Moos R, Fallowfield L, Mathias SD, Patrick DL, Clemons M, Tonkin K, Masuda N, 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 119: 832-838, 2013.
40. Webster K, Cella D and Yost K: The functional assessment of chronic illness therapy (FACIT) measurement system: properties, applications, and interpretation. Health Qual Life Outcomes 1: 79, 2003.
41. Coleman RE: Skeletal complications of malignancy. Cancer 80: 1588-1594, 1997.
42. Kristensen B, Ejlertsen B, Groenvold M, Hein S, Loft H and Mouridsen HT: Oral clodronate in breast cancer patients with bone metastases: a randomized study. J Intern Med 246: 67-74, 1999.
43. Body JJ, Lichinitser M, Tjulandin S, Garnero P and Bergström B: Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases. Ann Oncol 18: 1165-1171, 2007.
44. Kohno N, Aogi K, Minami H, Nakamura S, Asaga T, Iino Y, Watanabe T, Goessl C, Ohashi Y and Takashima S: 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: 3314-3321, 2005.
45. Olson K and Van Poznak C: Significance and impact of bisphosphonate-induced acute phase responses. J Oncol Pharm Pract 13: 223-229, 2007.