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

This study compared denosumab, a fully human monoclonal anti-receptor activator of nuclear factor kappa-B ligand antibody, with zoledronic acid (ZA) for delaying or preventing skeletal-related events (SRE) in patients with advanced cancer and bone metastases (excluding breast and prostate) or myelom...

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Vydáno v:	Journal of clinical oncology Ročník 29; číslo 9; s. 1125
Hlavní autoři:	Henry, David H, Costa, Luis, Goldwasser, Francois, Hirsh, Vera, Hungria, Vania, Prausova, Jana, Scagliotti, Giorgio Vittorio, Sleeboom, Harm, Spencer, Andrew, Vadhan-Raj, Saroj, von Moos, Roger, Willenbacher, Wolfgang, Woll, Penella J, Wang, Jianming, Jiang, Qi, Jun, Susie, Dansey, Roger, Yeh, Howard
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 20.03.2011
Témata:	Adolescent Adult Aged Aged, 80 and over Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bone Density Conservation Agents - therapeutic use Bone Neoplasms - drug therapy Bone Neoplasms - secondary Denosumab Diphosphonates - therapeutic use Double-Blind Method Female Humans Imidazoles - therapeutic use International Agencies Male Middle Aged Multiple Myeloma - drug therapy Multiple Myeloma - pathology Neoplasms - drug therapy Neoplasms - pathology RANK Ligand - therapeutic use Survival Rate Treatment Outcome Young Adult
ISSN:	1527-7755, 1527-7755
On-line přístup:	Zjistit podrobnosti o přístupu
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Abstract	This study compared denosumab, a fully human monoclonal anti-receptor activator of nuclear factor kappa-B ligand antibody, with zoledronic acid (ZA) for delaying or preventing skeletal-related events (SRE) in patients with advanced cancer and bone metastases (excluding breast and prostate) or myeloma. Eligible patients were randomly assigned in a double-blind, double-dummy design to receive monthly subcutaneous denosumab 120 mg (n = 886) or intravenous ZA 4 mg (dose adjusted for renal impairment; n = 890). Daily supplemental calcium and vitamin D were strongly recommended. The primary end point was time to first on-study SRE (pathologic fracture, radiation or surgery to bone, or spinal cord compression). Denosumab was noninferior to ZA in delaying time to first on-study SRE (hazard ratio, 0.84; 95% CI, 0.71 to 0.98; P = .0007). Although directionally favorable, denosumab was not statistically superior to ZA in delaying time to first on-study SRE (P = .03 unadjusted; P = .06 adjusted for multiplicity) or time to first-and-subsequent (multiple) SRE (rate ratio, 0.90; 95% CI, 0.77 to 1.04; P = .14). Overall survival and disease progression were similar between groups. Hypocalcemia occurred more frequently with denosumab. Osteonecrosis of the jaw occurred at similarly low rates in both groups. Acute-phase reactions after the first dose occurred more frequently with ZA, as did renal adverse events and elevations in serum creatinine based on National Cancer Institute Common Toxicity Criteria for Adverse Events grading. Denosumab was noninferior (trending to superiority) to ZA in preventing or delaying first on-study SRE in patients with advanced cancer metastatic to bone or myeloma. Denosumab represents a potential novel treatment option with the convenience of subcutaneous administration and no requirement for renal monitoring or dose adjustment.
AbstractList	This study compared denosumab, a fully human monoclonal anti-receptor activator of nuclear factor kappa-B ligand antibody, with zoledronic acid (ZA) for delaying or preventing skeletal-related events (SRE) in patients with advanced cancer and bone metastases (excluding breast and prostate) or myeloma.PURPOSEThis study compared denosumab, a fully human monoclonal anti-receptor activator of nuclear factor kappa-B ligand antibody, with zoledronic acid (ZA) for delaying or preventing skeletal-related events (SRE) in patients with advanced cancer and bone metastases (excluding breast and prostate) or myeloma.Eligible patients were randomly assigned in a double-blind, double-dummy design to receive monthly subcutaneous denosumab 120 mg (n = 886) or intravenous ZA 4 mg (dose adjusted for renal impairment; n = 890). Daily supplemental calcium and vitamin D were strongly recommended. The primary end point was time to first on-study SRE (pathologic fracture, radiation or surgery to bone, or spinal cord compression).PATIENTS AND METHODSEligible patients were randomly assigned in a double-blind, double-dummy design to receive monthly subcutaneous denosumab 120 mg (n = 886) or intravenous ZA 4 mg (dose adjusted for renal impairment; n = 890). Daily supplemental calcium and vitamin D were strongly recommended. The primary end point was time to first on-study SRE (pathologic fracture, radiation or surgery to bone, or spinal cord compression).Denosumab was noninferior to ZA in delaying time to first on-study SRE (hazard ratio, 0.84; 95% CI, 0.71 to 0.98; P = .0007). Although directionally favorable, denosumab was not statistically superior to ZA in delaying time to first on-study SRE (P = .03 unadjusted; P = .06 adjusted for multiplicity) or time to first-and-subsequent (multiple) SRE (rate ratio, 0.90; 95% CI, 0.77 to 1.04; P = .14). Overall survival and disease progression were similar between groups. Hypocalcemia occurred more frequently with denosumab. Osteonecrosis of the jaw occurred at similarly low rates in both groups. Acute-phase reactions after the first dose occurred more frequently with ZA, as did renal adverse events and elevations in serum creatinine based on National Cancer Institute Common Toxicity Criteria for Adverse Events grading.RESULTSDenosumab was noninferior to ZA in delaying time to first on-study SRE (hazard ratio, 0.84; 95% CI, 0.71 to 0.98; P = .0007). Although directionally favorable, denosumab was not statistically superior to ZA in delaying time to first on-study SRE (P = .03 unadjusted; P = .06 adjusted for multiplicity) or time to first-and-subsequent (multiple) SRE (rate ratio, 0.90; 95% CI, 0.77 to 1.04; P = .14). Overall survival and disease progression were similar between groups. Hypocalcemia occurred more frequently with denosumab. Osteonecrosis of the jaw occurred at similarly low rates in both groups. Acute-phase reactions after the first dose occurred more frequently with ZA, as did renal adverse events and elevations in serum creatinine based on National Cancer Institute Common Toxicity Criteria for Adverse Events grading.Denosumab was noninferior (trending to superiority) to ZA in preventing or delaying first on-study SRE in patients with advanced cancer metastatic to bone or myeloma. Denosumab represents a potential novel treatment option with the convenience of subcutaneous administration and no requirement for renal monitoring or dose adjustment.CONCLUSIONDenosumab was noninferior (trending to superiority) to ZA in preventing or delaying first on-study SRE in patients with advanced cancer metastatic to bone or myeloma. Denosumab represents a potential novel treatment option with the convenience of subcutaneous administration and no requirement for renal monitoring or dose adjustment. This study compared denosumab, a fully human monoclonal anti-receptor activator of nuclear factor kappa-B ligand antibody, with zoledronic acid (ZA) for delaying or preventing skeletal-related events (SRE) in patients with advanced cancer and bone metastases (excluding breast and prostate) or myeloma. Eligible patients were randomly assigned in a double-blind, double-dummy design to receive monthly subcutaneous denosumab 120 mg (n = 886) or intravenous ZA 4 mg (dose adjusted for renal impairment; n = 890). Daily supplemental calcium and vitamin D were strongly recommended. The primary end point was time to first on-study SRE (pathologic fracture, radiation or surgery to bone, or spinal cord compression). Denosumab was noninferior to ZA in delaying time to first on-study SRE (hazard ratio, 0.84; 95% CI, 0.71 to 0.98; P = .0007). Although directionally favorable, denosumab was not statistically superior to ZA in delaying time to first on-study SRE (P = .03 unadjusted; P = .06 adjusted for multiplicity) or time to first-and-subsequent (multiple) SRE (rate ratio, 0.90; 95% CI, 0.77 to 1.04; P = .14). Overall survival and disease progression were similar between groups. Hypocalcemia occurred more frequently with denosumab. Osteonecrosis of the jaw occurred at similarly low rates in both groups. Acute-phase reactions after the first dose occurred more frequently with ZA, as did renal adverse events and elevations in serum creatinine based on National Cancer Institute Common Toxicity Criteria for Adverse Events grading. Denosumab was noninferior (trending to superiority) to ZA in preventing or delaying first on-study SRE in patients with advanced cancer metastatic to bone or myeloma. Denosumab represents a potential novel treatment option with the convenience of subcutaneous administration and no requirement for renal monitoring or dose adjustment.
Author	Sleeboom, Harm Scagliotti, Giorgio Vittorio Hirsh, Vera Woll, Penella J Yeh, Howard Hungria, Vania Costa, Luis Henry, David H Jun, Susie Willenbacher, Wolfgang Wang, Jianming Vadhan-Raj, Saroj Prausova, Jana Spencer, Andrew Jiang, Qi Goldwasser, Francois von Moos, Roger Dansey, Roger
Author_xml	– sequence: 1 givenname: David H surname: Henry fullname: Henry, David H email: davidhenry@pennoncology.com organization: Joan Karnell Cancer Center, Philadelphia, PA 19106, USA. davidhenry@pennoncology.com – sequence: 2 givenname: Luis surname: Costa fullname: Costa, Luis – sequence: 3 givenname: Francois surname: Goldwasser fullname: Goldwasser, Francois – sequence: 4 givenname: Vera surname: Hirsh fullname: Hirsh, Vera – sequence: 5 givenname: Vania surname: Hungria fullname: Hungria, Vania – sequence: 6 givenname: Jana surname: Prausova fullname: Prausova, Jana – sequence: 7 givenname: Giorgio Vittorio surname: Scagliotti fullname: Scagliotti, Giorgio Vittorio – sequence: 8 givenname: Harm surname: Sleeboom fullname: Sleeboom, Harm – sequence: 9 givenname: Andrew surname: Spencer fullname: Spencer, Andrew – sequence: 10 givenname: Saroj surname: Vadhan-Raj fullname: Vadhan-Raj, Saroj – sequence: 11 givenname: Roger surname: von Moos fullname: von Moos, Roger – sequence: 12 givenname: Wolfgang surname: Willenbacher fullname: Willenbacher, Wolfgang – sequence: 13 givenname: Penella J surname: Woll fullname: Woll, Penella J – sequence: 14 givenname: Jianming surname: Wang fullname: Wang, Jianming – sequence: 15 givenname: Qi surname: Jiang fullname: Jiang, Qi – sequence: 16 givenname: Susie surname: Jun fullname: Jun, Susie – sequence: 17 givenname: Roger surname: Dansey fullname: Dansey, Roger – sequence: 18 givenname: Howard surname: Yeh fullname: Yeh, Howard
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/21343556$$D View this record in MEDLINE/PubMed
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Snippet	This study compared denosumab, a fully human monoclonal anti-receptor activator of nuclear factor kappa-B ligand antibody, with zoledronic acid (ZA) for...
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SubjectTerms	Adolescent Adult Aged Aged, 80 and over Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bone Density Conservation Agents - therapeutic use Bone Neoplasms - drug therapy Bone Neoplasms - secondary Denosumab Diphosphonates - therapeutic use Double-Blind Method Female Humans Imidazoles - therapeutic use International Agencies Male Middle Aged Multiple Myeloma - drug therapy Multiple Myeloma - pathology Neoplasms - drug therapy Neoplasms - pathology RANK Ligand - therapeutic use Survival Rate Treatment Outcome Young Adult
Title	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
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