Supportive Care in Cancer

, Volume 21, Issue 12, pp 3497–3507

Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid

  • Roger von Moos
  • Jean-Jacques Body
  • Blair Egerdie
  • Alison Stopeck
  • Janet E. Brown
  • Danail Damyanov
  • Lesley J. Fallowfield
  • Gavin Marx
  • Charles S. Cleeland
  • Donald L. Patrick
  • Felipe G. Palazzo
  • Yi Qian
  • Ada Braun
  • Karen Chung
Original Article

Abstract

Purpose

This analysis evaluated patient-reported outcomes and analgesic use in patients with bone metastases from solid tumours across three comparative studies of denosumab and zoledronic acid.

Methods

Pooled data were analysed from three identically designed double-blind phase III studies comparing subcutaneous denosumab 120 mg with intravenous zoledronic acid 4 mg monthly in patients with bone metastases from breast cancer (n = 2,046), castration-resistant prostate cancer (n = 1,901) or other solid tumours (n = 1,597). Pain severity, pain interference, health-related quality of life and analgesic use were quantified.

Results

At baseline, approximately half of patients had no/mild pain (53 % [1,386/2,620] denosumab; 50 % [1,297/2,578] zoledronic acid). Denosumab delayed onset of moderate/severe pain by 1.8 months (median, 6.5 vs 4.7 months; hazard ratio, 0.83; 95 % CI, 0.76–0.92; p < 0.001; 17 % risk reduction) and clinically meaningful increases in overall pain interference by 2.6 months (median, 10.3 vs 7.7 months; hazard ratio, 0.83; 95 % CI, 0.75–0.92; p < 0.001; 17 % risk reduction) compared with zoledronic acid. Strong opioid use and worsening of health-related quality of life were less common with denosumab.

Conclusions

Across three large studies of patients with advanced solid tumours and bone metastases, denosumab prevented progression of pain severity and pain interference more effectively than zoledronic acid.

Keywords

Denosumab Bone metastases Pain Solid tumours Zoledronic acid 

Supplementary material

520_2013_1932_MOESM1_ESM.docx (52 kb)
ESM 1(DOCX 52.4 kb)
520_2013_1932_MOESM2_ESM.docx (80 kb)
ESM 2(DOCX 79 kb)

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Roger von Moos
    • 1
  • Jean-Jacques Body
    • 2
  • Blair Egerdie
    • 3
  • Alison Stopeck
    • 4
  • Janet E. Brown
    • 5
  • Danail Damyanov
    • 6
  • Lesley J. Fallowfield
    • 7
  • Gavin Marx
    • 8
  • Charles S. Cleeland
    • 9
  • Donald L. Patrick
    • 10
  • Felipe G. Palazzo
    • 11
  • Yi Qian
    • 12
  • Ada Braun
    • 12
  • Karen Chung
    • 12
  1. 1.Kantonsspital GraubündenChurSwitzerland
  2. 2.Chu BrugmannUniversité Libre De BruxellesBrusselsBelgium
  3. 3.Urology Associates/Urologic Medical ResearchKitchenerCanada
  4. 4.Arizona Cancer CenterUniversity of ArizonaTucsonUSA
  5. 5.Cancer Research UK Experimental Cancer Medicine CentresLeeds and SheffieldUK
  6. 6.National Hospital for Treatment in OncologySofiaBulgaria
  7. 7.Sussex Health Outcomes Research & Education in Cancer (SHORE-C)University of SussexBrightonUK
  8. 8.Sydney Adventist HospitalUniversity of SydneySydneyAustralia
  9. 9.University of Texas MD Anderson Cancer CenterHoustonUSA
  10. 10.University of WashingtonSeattleUSA
  11. 11.CAIPOSan Miguel de TucumanArgentina
  12. 12.Amgen Inc.Thousand OaksUSA

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