Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors

Henry, David; Vadhan-Raj, Saroj; Hirsh, Vera; von Moos, Roger; Hungria, Vania; Costa, Luis; Woll, Penella J; Scagliotti, Giorgio; Smith, Geoffrey; Feng, Amy; Jun, Susie; Dansey, Roger; Yeh, Howard

doi:10.1007/s00520-013-2022-1

Cited by 184Bone health and treatmentsBone health and osteoporosis researchManagement of metastatic bone disease

Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors

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Henry, David, Vadhan-Raj, Saroj, Hirsh, Vera, von Moos, Roger, Hungria, Vania, Costa, Luis, Woll, Penella J, Scagliotti, Giorgio +5 more·2014·Supportive Care in Cancer

DOI 10.1007/s00520-013-2022-1

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Abstract

Purpose Bone complications of metastatic disease, including skeletal-related events (SREs), impair patients' functioning and quality of life. In a randomized, phase 3 trial of 1,776 patients with metastases from solid tumors (except breast or prostate) or multiple myeloma, denosumab was non-inferior to zoledronic acid (ZA) in delaying or preventing SREs. This ad hoc analysis reports outcomes in the subgroup of 1,597 patients with solid tumors, excluding patients with multiple myeloma.Methods Patients received monthly subcutaneous denosumab 120 mg or intravenous ZA 4 mg, adjusted for creatinine clearance, with calcium and vitamin D supplementation recommended. Endpoints included times to first on-study SRE, first-and-subsequent SREs, and pain worsening.Results Denosumab significantly delayed time to first on-study SRE compared with ZA (HR, 0.81; 95 % CI, 0.68-0.96) and time to first-and-subsequent SREs (RR, 0.85; 95 % CI, 0.72-1.00). Denosumab also significantly delayed time to development of moderate or severe pain (HR, 0.81; 95 % CI, 0.66-1.00), pain worsening (HR, 0.83; 95 % CI, 0.71-0.97), and worsening pain interference in patients with no/mild baseline pain (HR, 0.77; 95 % CI, 0.61-0.96). Adverse event rates were 96 % in both groups. Grade 3 or 4 hypocalcemia, mostly without clinical sequelae, was more frequent in denosumab-treated patients (denosumab 4 %, ZA 2 %). Osteonecrosis of the jaw occurred infrequently (denosumab 0.8 %, ZA 1.1 %).Conclusions Denosumab was more effective in delaying or preventing SREs in patients with bone metastases from solid tumors and also prevented pain progression compared to ZA in this ad hoc analysis.

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In a study of denosumab versus zoledronic acid in advanced cancers, the time until pain interfered with daily life was longer in denosumab-treated patients who had no or mild pain interference at baseline.
“In the study of denosumab versus zoledronic acid in patients with advanced cancers, the time extent to which pain interfered with daily life (used as surrogate for QoL) was longer in patients treated with denosumab and with no pain or mild pain interference at baseline [163].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [163]

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AOS13 Denosumab versus zoledronic acid for the prevention of skeletal-related events in patients with bone metastases secondary to solid tumours: An integrated analysis of three phase 3 studies
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Authors: Henry, D., Vadhan-Raj, S., Hirsh, V., von Moos, R., Hungria, V., Costa, L., Woll, P. J., Scagliotti, G., Smith, G., Feng, A., Jun, S., Dansey, R., & Yeh, H.
Affiliations: Pennsylvania Hospital (US)
McGill University Health Centre (CA)
University of Sheffield (GB)
University of Turin (IT)
Amgen (United States) (US)
Corresponding author: Henry, David
ORCID: Henry, David
Woll, Penella J
Scagliotti, Giorgio
Venue: Supportive Care in Cancer
Publisher: Springer Science and Business Media LLC
Published: 2013-10-26
Volume: 22
Issue: 3
Pages: 679-687
ISSN: 0941-4355 (ISSN-L)
1433-7339
DOI: 10.1007/s00520-013-2022-1
OpenAlex: W2066699153
Cited by: 183
References: 23
Citations by year: 2026: 2 · 2025: 11 · 2024: 13 · 2023: 16 · 2022: 13 · 2021: 11 · 2020: 21 · 2019: 17 · 2018: 14 · 2017: 10 · 2016: 16 · 2015: 21 · 2014: 16 · 2013: 1
FWCI: 9.64
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.springer.com/tdm (tdm)
Locations: Supportive Care in Cancer (publishedVersion)
PubMed (publishedVersion)
Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
Funders: Amgen
Topics: Health Sciences › Medicine › Oncology › Bone health and treatments
Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
Health Sciences › Medicine › Surgery › Management of metastatic bone disease
Keywords: denosumab, zoledronic acid, skeletal-related events, bone metastasis, solid tumors, bone pain, hypocalcemia, osteonecrosis of the jaw, bisphosphonates, non-inferiority, metastatic cancer
MeSH terms: Denosumab, Zoledronic Acid, Adolescent, Adult, Aged, Aged, 80 and over, Bone Neoplasms, Bone Resorption, Diphosphonates, Double-Blind Method, Female, Humans, Imidazoles, Male, Middle Aged, Multiple Myeloma, Neoplasms, Pain, Treatment Outcome, Disease Progression, Bone Density Conservation Agents, Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized

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Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors

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