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 T 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

Research output: Contribution to journalArticle

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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 qI 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.

Original languageEnglish (US)
Pages (from-to)3497-3507
Number of pages11
JournalSupportive Care in Cancer
Volume21
Issue number12
DOIs
StatePublished - Dec 2013

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zoledronic acid
Double-Blind Method
Quality of Life
Neoplasm Metastasis
Bone and Bones
Pain
Neoplasms
Risk Reduction Behavior
Analgesics
Qi
Castration
Denosumab
Opioid Analgesics
Prostatic Neoplasms

Keywords

  • Bone metastases
  • Denosumab
  • Pain
  • Solid tumours
  • Zoledronic acid

ASJC Scopus subject areas

  • Oncology

Cite this

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. / Von Moos, Roger; Body, Jean Jacques; Egerdie, Blair; Stopeck, Alison T; Brown, Janet E.; Damyanov, Danail; Fallowfield, Lesley J.; Marx, Gavin; Cleeland, Charles S.; Patrick, Donald L.; Palazzo, Felipe G.; Qian, Yi; Braun, Ada; Chung, Karen.

In: Supportive Care in Cancer, Vol. 21, No. 12, 12.2013, p. 3497-3507.

Research output: Contribution to journalArticle

Von Moos, R, Body, JJ, Egerdie, B, Stopeck, AT, Brown, JE, Damyanov, D, Fallowfield, LJ, Marx, G, Cleeland, CS, Patrick, DL, Palazzo, FG, Qian, Y, Braun, A & Chung, K 2013, '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', Supportive Care in Cancer, vol. 21, no. 12, pp. 3497-3507. https://doi.org/10.1007/s00520-013-1932-2
Von Moos, Roger ; Body, Jean Jacques ; Egerdie, Blair ; Stopeck, Alison T ; Brown, Janet E. ; Damyanov, Danail ; Fallowfield, Lesley J. ; Marx, Gavin ; Cleeland, Charles S. ; Patrick, Donald L. ; Palazzo, Felipe G. ; Qian, Yi ; Braun, Ada ; Chung, Karen. / 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. In: Supportive Care in Cancer. 2013 ; Vol. 21, No. 12. pp. 3497-3507.
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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 qI 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.",
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T2 - Integrated results from three randomized, double-blind studies of denosumab and zoledronic acid

AU - Von Moos, Roger

AU - Body, Jean Jacques

AU - Egerdie, Blair

AU - Stopeck, Alison T

AU - Brown, Janet E.

AU - Damyanov, Danail

AU - Fallowfield, Lesley J.

AU - Marx, Gavin

AU - Cleeland, Charles S.

AU - Patrick, Donald L.

AU - Palazzo, Felipe G.

AU - Qian, Yi

AU - Braun, Ada

AU - Chung, Karen

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N2 - 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 qI 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.

AB - 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 qI 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.

KW - Bone metastases

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KW - Pain

KW - Solid tumours

KW - Zoledronic acid

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