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Start Over Author "Stopeck AT" Journal supportive care in cancer
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4. Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer

Author

Stopeck, Alison T., Fizazi, Karim, Body, Jean-Jacques, Brown, Janet E., Carducci, Michael, Diel, Ingo, Fujiwara, Yasuhiro, Martín, Miguel, Paterson, Alexander, Tonkin, Katia, Shore, Neal, Sieber, Paul, Kueppers, Frank, Karsh, Lawrence, Yardley, Denise, Wang, Huei, Maniar, Tapan, Arellano, Jorge, and Braun, Ada

Published
2016
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6. Erratum to: Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer

Author

Stopeck, Alison T., Fizazi, Karim, Body, Jean-Jacques, Brown, Janet E., Carducci, Michael, Diel, Ingo, Fujiwara, Yasuhiro, Martín, Miguel, Paterson, Alexander, Tonkin, Katia, Shore, Neal, Sieber, Paul, Kueppers, Frank, Karsh, Lawrence, Yardley, Denise, Wang, Huei, Maniar, Tapan, Arellano, Jorge, and Braun, Ada

Published
2016
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8. Erratum to: 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

Author

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

Published
2014
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9. 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

Author

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

Subjects
Adult, Male, Oncology, medicine.medical_specialty, Pain medicine, Analgesic, Pain, Bone Neoplasms, Breast Neoplasms, Antibodies, Monoclonal, Humanized, Zoledronic Acid, law.invention, Young Adult, Double-Blind Method, Randomized controlled trial, Quality of life, law, Neoplasms, Internal medicine, medicine, Humans, In patient, Aged, Aged, 80 and over, Analgesics, Bone Density Conservation Agents, Diphosphonates, business.industry, Imidazoles, Middle Aged, Clinical trial, Prostatic Neoplasms, Castration-Resistant, Denosumab, Zoledronic acid, Quality of Life, Female, business, medicine.drug
Abstract

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.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.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.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.

Published
2013

11. Erratum to: 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

Author

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

Subjects
Oncology, Health related quality of life, medicine.medical_specialty, business.industry, Cancer, medicine.disease, Surgery, Double blind, Zoledronic acid, Denosumab, Internal medicine, medicine, Support care, In patient, business, medicine.drug
Published
2014

12. Erratum to: Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer

Author

Stopeck, Alison T., primary, Fizazi, Karim, additional, Body, Jean-Jacques, additional, Brown, Janet E., additional, Carducci, Michael, additional, Diel, Ingo, additional, Fujiwara, Yasuhiro, additional, Martín, Miguel, additional, Paterson, Alexander, additional, Tonkin, Katia, additional, Shore, Neal, additional, Sieber, Paul, additional, Kueppers, Frank, additional, Karsh, Lawrence, additional, Yardley, Denise, additional, Wang, Huei, additional, Maniar, Tapan, additional, Arellano, Jorge, additional, and Braun, Ada, additional

Published
2015
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13. Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer

Author

Stopeck, Alison T., primary, Fizazi, Karim, additional, Body, Jean-Jacques, additional, Brown, Janet E., additional, Carducci, Michael, additional, Diel, Ingo, additional, Fujiwara, Yasuhiro, additional, Martín, Miguel, additional, Paterson, Alexander, additional, Tonkin, Katia, additional, Shore, Neal, additional, Sieber, Paul, additional, Kueppers, Frank, additional, Karsh, Lawrence, additional, Yardley, Denise, additional, Wang, Huei, additional, Maniar, Tapan, additional, Arellano, Jorge, additional, and Braun, Ada, additional

Published
2015
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14. Pain and analgesic use associated with skeletal-related events in patients with advanced cancer and bone metastases

Author

von Moos, Roger, primary, Body, Jean-Jacques, additional, Egerdie, Blair, additional, Stopeck, Alison, additional, Brown, Janet, additional, Fallowfield, Lesley, additional, Patrick, Donald L., additional, Cleeland, Charles, additional, Damyanov, Danail, additional, Palazzo, Felipe Salvador, additional, Marx, Gavin, additional, Zhou, Ying, additional, Braun, Ada, additional, Balakumaran, Arun, additional, and Qian, Yi, additional

Published
2015
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15. Pain and analgesic use associated with skeletal-related events in patients with advanced cancer and bone metastases.

Author

Moos, Roger, Body, Jean-Jacques, Egerdie, Blair, Stopeck, Alison, Brown, Janet, Fallowfield, Lesley, Patrick, Donald, Cleeland, Charles, Damyanov, Danail, Palazzo, Felipe, Marx, Gavin, Zhou, Ying, Braun, Ada, Balakumaran, Arun, Qian, Yi, von Moos, Roger, Patrick, Donald L, and Palazzo, Felipe Salvador

Subjects
ZOLEDRONIC acid, PAIN, BRIEF Pain Inventory, ANALGESICS, CANCER research, BONE metastasis, BONE tumors, COMPARATIVE studies, DIPHOSPHONATES, SPONTANEOUS fractures, IMIDAZOLES, RESEARCH methodology, MEDICAL cooperation, METASTASIS, QUESTIONNAIRES, RESEARCH, RESEARCH funding, EVALUATION research, DISEASE complications, THERAPEUTICS
Abstract

Purpose: Bone metastases secondary to solid tumors increase the risk of skeletal-related events (SREs), including the occurrence of pathological fracture (PF), radiation to bone (RB), surgery to bone (SB), and spinal cord compression (SCC). The aim of this study was to evaluate the impact of SREs on patients' pain, analgesic use, and pain interference with daily functioning.Methods: Data were combined from patients with solid tumors and bone metastases who received denosumab or zoledronic acid across three identically designed phase 3 trials (N = 5543). Pain severity (worst pain) and pain interference were assessed using the Brief Pain Inventory at baseline and each monthly visit. Analgesic use was quantified using the Analgesic Quantification Algorithm.Results: The proportion of patients with moderate/severe pain and strong opioid use generally increased in the 6 months preceding an SRE and remained elevated, while they remained relatively consistent over time in patients without an SRE. Regression analysis indicated that all SRE types were significantly associated with an increased risk of progression to moderate/severe pain and strong opioid use. PF, RB, and SCC were associated with significantly greater risk of pain interference overall. Results were similar for pain interference with emotional well-being. All SRE types were associated with significantly greater risk of pain interference with physical function.Conclusions: SREs are associated with increased pain and analgesic use in patients with bone metastases. Treatments that prevent SREs may decrease pain and the need for opioid analgesics and reduce the impact of pain on daily functioning. [ABSTRACT FROM AUTHOR]

Published
2016
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16. Response to letter to the Editors—Safety of long-term denosumab therapy

Author

Douglas Warner and Alison Stopeck

Subjects
medicine.medical_specialty, Bone Density Conservation Agents, business.industry, Nursing research, Pain medicine, Denosumab therapy, Term (time), 03 medical and health sciences, 0302 clinical medicine, Oncology, Bone Density, 030220 oncology & carcinogenesis, Humans, Medicine, 030212 general & internal medicine, Denosumab, business, Intensive care medicine
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