Risk factors of skeletal-related events in patients with bone metastasis from non-small cell lung cancer undergoing treatment with zoledronate-a post hoc analysis of a randomized clinical trial.
Bone Density Conservation Agents
/ adverse effects
Bone Neoplasms
/ secondary
Carcinoma, Non-Small-Cell Lung
/ complications
Drug-Related Side Effects and Adverse Reactions
/ complications
Female
Humans
Lung Neoplasms
/ complications
Male
Middle Aged
Musculoskeletal Abnormalities
Proportional Hazards Models
Randomized Controlled Trials as Topic
Risk Factors
Zoledronic Acid
/ adverse effects
Albumin
Alkaline phosphatase
Bone metastasis
Non-small cell lung cancer
Skeletal related events
Journal
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
ISSN: 1433-7339
Titre abrégé: Support Care Cancer
Pays: Germany
ID NLM: 9302957
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
received:
02
05
2020
accepted:
30
07
2020
pubmed:
5
8
2020
medline:
9
3
2021
entrez:
5
8
2020
Statut:
ppublish
Résumé
Skeletal-related events (SREs) are critical events for patients with bone metastasis from non-small cell lung cancer (NSCLC). Thus, bone-modifying agents are recommended in this population. However, the baseline risk factors of SREs in patients with bone metastasis from NSCLC are not well established. We analyzed the patient-level data from the zoledronate arm of a clinical trial comparing denosumab with zoledronate in patients with bone metastasis ( ClinicalTrial.gov ID: NCT00330759) available at Project Data Sphere, a broad-access research platform. The primary endpoint was the first SRE from the inclusion to the trial, and the time to the first SRE was analyzed using Cox proportional hazards model. We analyzed 302 patients with NSCLC without a documented history of osteopenia or osteoporosis included in the zoledronate arm of the trial. Ninety-eight patients (32%) had at least one SRE. The univariate analysis showed that low serum albumin and elevated serum alkaline phosphatase (ALP) are significant baseline risk factors for SREs (hazard ratio (HR) [95% confidence interval (CI)]; 2.27 [1.43-3.61], and 1.91 [1.26-2.90], respectively). Additionally, osteoblastic and mixed type of bone metastasis showed a significantly lower risk of SREs compared with the osteolytic lesion (HR [95% CI]; 0.39 [0.21-0.72], and 0.31 [0.15-0.63], respectively). These factors also showed a significant association with the risk of SREs in multivariate analysis. We revealed that osteolytic bone metastasis, low serum albumin, and elevated serum ALP are risk factors for SREs in patients with bone metastasis from NSCLC.
Sections du résumé
BACKGROUND
BACKGROUND
Skeletal-related events (SREs) are critical events for patients with bone metastasis from non-small cell lung cancer (NSCLC). Thus, bone-modifying agents are recommended in this population. However, the baseline risk factors of SREs in patients with bone metastasis from NSCLC are not well established.
METHODS
METHODS
We analyzed the patient-level data from the zoledronate arm of a clinical trial comparing denosumab with zoledronate in patients with bone metastasis ( ClinicalTrial.gov ID: NCT00330759) available at Project Data Sphere, a broad-access research platform. The primary endpoint was the first SRE from the inclusion to the trial, and the time to the first SRE was analyzed using Cox proportional hazards model.
RESULTS
RESULTS
We analyzed 302 patients with NSCLC without a documented history of osteopenia or osteoporosis included in the zoledronate arm of the trial. Ninety-eight patients (32%) had at least one SRE. The univariate analysis showed that low serum albumin and elevated serum alkaline phosphatase (ALP) are significant baseline risk factors for SREs (hazard ratio (HR) [95% confidence interval (CI)]; 2.27 [1.43-3.61], and 1.91 [1.26-2.90], respectively). Additionally, osteoblastic and mixed type of bone metastasis showed a significantly lower risk of SREs compared with the osteolytic lesion (HR [95% CI]; 0.39 [0.21-0.72], and 0.31 [0.15-0.63], respectively). These factors also showed a significant association with the risk of SREs in multivariate analysis.
CONCLUSIONS
CONCLUSIONS
We revealed that osteolytic bone metastasis, low serum albumin, and elevated serum ALP are risk factors for SREs in patients with bone metastasis from NSCLC.
Identifiants
pubmed: 32747990
doi: 10.1007/s00520-020-05665-w
pii: 10.1007/s00520-020-05665-w
doi:
Substances chimiques
Bone Density Conservation Agents
0
Zoledronic Acid
6XC1PAD3KF
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1629-1633Références
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