Clinical benefit in patients with metastatic bone disease: Results of a phase 3 study of denosumab versus zoledronic acid

Annals of Oncology

Volumn 23, Issue 12, 2012, Pages 3045-3051

  Vadhan Raj, S ^a   Von Moos, R ^b   Fallowfield, L J ^c   Patrick, D L ^d   Goldwasser, F ^e   Cleeland, C S ^a   Henry, D H ^f   Novello, S ^g   Hungria, V ^h   Qian, Y ⁱ   Feng, A ⁱ   Yeh, H ⁱ   Chung, K ⁱ  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b KANTONSSPITAL GRAUBÜNDEN   (Switzerland)

^c UNIVERSITY OF SUSSEX   (United Kingdom)

^d UNIVERSITY OF WASHINGTON   (United States)

^e UNIVERSITÉ PARIS DESCARTES   (France)

^f PENNSYLVANIA HOSPITAL   (United States)

^g UNIVERSITY OF TURIN   (Italy)

^h IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE SÃO PAULO   (Brazil)

ⁱ AMGEN INC   (United States)

Author keywords

Bone pain; Denosumab; Metastatic bone disease; Quality of life; Skeletal related events; Zoledronic acid

Indexed keywords

BUPRENORPHINE; CALCIUM; DENOSUMAB; FENTANYL; HYDROMORPHONE; MORPHINE; NARCOTIC ANALGESIC AGENT; OXYCODONE; PLACEBO; VITAMIN D; ZOLEDRONIC ACID;

ADULT; ADVANCED CANCER; ARTICLE; BONE DISEASE; BONE METASTASIS; BONE PAIN; CANCER CONTROL; CANCER SURVIVAL; CONTROLLED STUDY; DISEASE CONTROL; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; HUMAN; MAJOR CLINICAL STUDY; METASTASIS POTENTIAL; MULTIPLE MYELOMA; NUMBERS NEEDED TO TREAT; PAIN ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RADIATION HAZARD; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; RISK REDUCTION; SOLID TUMOR; TREATMENT OUTCOME; VITAMIN SUPPLEMENTATION;

EID: 84869854156     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mds175     Document Type: Article

References (31)

1. Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res 2006; 12: 6243s-6249s.
2. Costa L, Badia X, Chow E et al. Impact of skeletal complications on patients' quality of life, mobility, and functional independence. Support Care Cancer 2008; 16: 879-889.
3. Costa L, Major PP. Effect of bisphosphonates on pain and quality of life in patients with bone metastases. Nat Clin Pract Oncol 2009; 6: 163-174.
4. Clare C, Royle D, Saharia K et al. Painful bone metastases: a prospective observational cohort study. Palliat Med 2005; 19: 521-525.
5. Cleeland CS. The measurement of pain from metastatic bone disease: capturing the patient's experience. Clin Cancer Res 2006; 12: 6236s-6242s.
6. Vainio A, Auvinen A. Prevalence of symptoms among patients with advanced cancer: an international collaborative study. Symptom Prevalence Group. J Pain Symptom Manage 1996; 12: 3-10.
7. 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: 1125-1132.
8. Leppert W. Pain management in patients with cancer: focus on opioid analgesics. Curr Pain Headache Rep 2011; 15: 271-279.
9. Azevedo Sao Leao Ferreira K, Kimura M, Jacobsen Teixeira M. The WHO analgesic ladder for cancer pain control, twenty years of use. How much pain relief does one get from using it? Support Care Cancer 2006; 14: 1086-1093.
10. Nicholson B. Responsible prescribing of opioids for the management of chronic pain. Drugs 2003; 63: 17-32.
11. von Moos R, Strasser F, Gillessen S et al. Metastatic bone pain: treatment options with an emphasis on bisphosphonates. Support Care Cancer 2008; 16: 1105-1115.
12. Temel JS, Greer JA, Muzikansky A et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010; 363: 733-742.
13. Dewar JA. Managing metastatic bone pain. BMJ 2004; 329: 812-813.
14. Novartis. Zometa (Zoledronic Acid) Injection, Concentrate for Intravenous Infusion [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation 2009.
15. 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, doubleblind, placebo-controlled trial. Cancer 2004; 100: 2613-2621.
16. 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 2003; 98: 1735-1744.
17. 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 2001; 7: 377-387.
18. 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 2008; 19: 420-432.
19. 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 2005; 23: 3314-3321.
20. Saad F, Gleason DM, Murray R et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormonerefractory prostate cancer. J Natl Cancer Inst 2004; 96: 879-882.
21. Amgen. XGEVA (Denosumab) Injection, for Subcutaneous Use [Prescribing Information]. Thousand Oaks, CA: Amgen Inc. 2012.
22. Hofbauer LC, Neubauer A, Heufelder AE. Receptor activator of nuclear factor-kappaB ligand and osteoprotegerin: potential implications for the pathogenesis and treatment of malignant bone diseases. Cancer 2001; 92: 460-470.
23. 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 2011; 377: 813-822.
24. 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: 1564-1571.
25. 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 2007; 25: 4431-4437.
26. 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: 5132-5139.
27. Cleeland C. Research in cancer pain. What we know and what we need to know. Cancer 1991; 67: 823-827.
28. Rosen LS, Gordon D, Tchekmedyian S et al. 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 2003; 21: 3150-3157.
29. Mathias SD, Crosby RD, Qian Y et al. Estimating minimally important differences for the worst pain rating of the Brief Pain Inventory-Short Form. J Support Oncol 2011; 9: 72-78.
30. Weinfurt KP, Anstrom KJ, Castel LD et al. Effect of zoledronic acid on pain associated with bone metastasis in patients with prostate cancer. Ann Oncol 2006; 17: 986-989.
31. Roque IFM, Martinez-Zapata MJ, Scott-Brown M et al. Radioisotopes for metastatic bone pain. Cochrane Database Syst Rev 2011; CD003347.