Clinical Benefit in Patients with Metastatic Bone Disease: Results of a Phase 3 Study of Denosumab Versus Zoledronic Acid

Details

• Personal Author:
  Chung K ; Cleeland CS ; Fallowfield LJ ; Feng, H. Amy ; Goldwasser F ; Henry DH ; Hungria V ; Novello S ; Patrick DL ; Qian Y ; Vadhan-Raj S ; von Moos R ; Yeh H
• Description:
  Background: Patients with metastatic bone disease are living longer in the metastatic stage due to improvements in cancer therapy, making strategies to prevent the aggravation of bone disease and its complications, such as skeletal-related events (SREs) and pain, increasingly important. Patients and results: In this phase 3 trial in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma, denosumab reduced the risk of radiation to bone by 22% relative to zoledronic acid (P = 0.026), prevented worsening of pain and pain interference (2-point increase in Brief Pain Inventory score; P < 0.05 versus zoledronic acid), and reduced the frequency of a shift from no/weak opioid analgesic use to strong opioids (P < 0.05 versus zoledronic acid at months 3-5). Denosumab delayed the time to moderate-to-severe pain compared with zoledronic acid in patients with mild or no pain at the baseline (P = 0.04), supporting early treatment. Health-related quality-of-life scores were similar in both groups. The number needed to treat to avoid one SRE for denosumab was 3 patient-years versus placebo and 10 patient-years versus zoledronic acid. Conclusion: The use of denosumab was associated with better prevention of the complications of metastatic bone disease secondary to solid tumors or multiple myeloma versus zoledronic acid. [Description provided by NIOSH]
• Subjects:
  Drug Therapy Neoplasms Occupational Health Safety
• Keywords:
  Author Keywords: Bone Pain Bone Cancer Cancer Cancer Survivors Denosumab Drug Therapy Medical Treatment Metastatic Bone Disease Metastatic Disease Quality Of Life Skeletal-related Events Zoledronic Acid

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• ISSN:
  0923-7534
• Document Type:
  Text
• Funding:
  Grant
• Genre:
  Journal Article
• Place as Subject:
  California ; OSHA Region 10 ; OSHA Region 3 ; OSHA Region 6 ; OSHA Region 9 ; Pennsylvania ; Texas ; Washington
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  23
• Issue:
  12
• NIOSHTIC Number:
  nn:20057202
• Citation:
  Ann Oncol 2012 Dec; 23(12):3045-3051
• Contact Point Address:
  Dr S. Vahdan-Raj, Section of Cytokines and Supportive Oncology, Unit 450, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA
• Email:
  svadhanr@mdanderson.org
• Federal Fiscal Year:
  2013
• Performing Organization:
  University of Washington
• Peer Reviewed:
  True
• Start Date:
  20050701
• Source Full Name:
  Annals of Oncology
• End Date:
  20250630
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:739b40b4c3d2aaa01a63d8174139a1a682a7f4c4a4a620477efcf778ec92bd4c863be42dfb8ae1449be8e0ff2fccd6ba87f96e5b6f5654427f9230de1867ad56
• Download URL:
  https://stacks.cdc.gov/view/cdc/214631/cdc_214631_DS1.pdf
• File Type:
  [PDF - 245.81 KB ]