Adjuvant Zoledronic Acid in High-Risk Giant Cell Tumor of Bone: A Multicenter Randomized Phase II Trial.
Adult
Aged
Bone Density Conservation Agents
/ therapeutic use
Bone Neoplasms
/ drug therapy
Case-Control Studies
Female
Follow-Up Studies
Giant Cell Tumor of Bone
/ drug therapy
Humans
Incidence
Male
Middle Aged
Neoplasm Recurrence, Local
/ diagnosis
Netherlands
/ epidemiology
Prognosis
Risk Factors
Survival Rate
Young Adult
Zoledronic Acid
/ therapeutic use
Journal
The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
received:
24
03
2019
accepted:
06
04
2019
pubmed:
2
5
2019
medline:
10
7
2020
entrez:
2
5
2019
Statut:
ppublish
Résumé
Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of giant cell tumor of bone (GCTB) in this study. The efficacy could not be determined because of the small sample size.GCTB recurrences, even in the denosumab era, are still an issue; therefore, a randomized study exploring the efficacy of zoledronic acid in the adjuvant setting in GCTB is still valid. Bisphosphonates are assumed to inhibit giant cell tumor of bone (GCTB)-associated osteoclast activity and have an apoptotic effect on the neoplastic mononuclear cell population. The primary objective of this study was to determine the 2-year recurrence rate of high-risk GCTB after adjuvant zoledronic acid versus standard care. In this multicenter randomized open-label phase II trial, patients with high-risk GCTB were included (December 2008 to October 2013). Recruitment was stopped because of low accrual after the introduction of denosumab. In the intervention group, patients received adjuvant zoledronic acid (4 mg) intravenously at 1, 2, 3, 6, 9, and 12 months after surgery. Fourteen patients were included (intervention Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of GCTB in this study. The efficacy could not be determined because of the small sample size. Because recurrences, even in the denosumab era, are still an issue, a randomized study exploring the efficacy of zoledronic acid in the adjuvant setting in GCTB is still valid.
Sections du résumé
LESSONS LEARNED
Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of giant cell tumor of bone (GCTB) in this study. The efficacy could not be determined because of the small sample size.GCTB recurrences, even in the denosumab era, are still an issue; therefore, a randomized study exploring the efficacy of zoledronic acid in the adjuvant setting in GCTB is still valid.
BACKGROUND
Bisphosphonates are assumed to inhibit giant cell tumor of bone (GCTB)-associated osteoclast activity and have an apoptotic effect on the neoplastic mononuclear cell population. The primary objective of this study was to determine the 2-year recurrence rate of high-risk GCTB after adjuvant zoledronic acid versus standard care.
METHODS
In this multicenter randomized open-label phase II trial, patients with high-risk GCTB were included (December 2008 to October 2013). Recruitment was stopped because of low accrual after the introduction of denosumab. In the intervention group, patients received adjuvant zoledronic acid (4 mg) intravenously at 1, 2, 3, 6, 9, and 12 months after surgery.
RESULTS
Fourteen patients were included (intervention
CONCLUSION
Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of GCTB in this study. The efficacy could not be determined because of the small sample size. Because recurrences, even in the denosumab era, are still an issue, a randomized study exploring the efficacy of zoledronic acid in the adjuvant setting in GCTB is still valid.
Identifiants
pubmed: 31040253
pii: theoncologist.2019-0280
doi: 10.1634/theoncologist.2019-0280
pmc: PMC6656477
doi:
Substances chimiques
Bone Density Conservation Agents
0
Zoledronic Acid
6XC1PAD3KF
Banques de données
ClinicalTrials.gov
['NCT00889590']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
889-e421Informations de copyright
© AlphaMed Press; the data published online to support this summary are the property of the authors.
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