Venous thromboembolism in breast cancer patients receiving cyclin-dependent kinase inhibitors.
CDK inhibitors
abemaciclib
breast cancer
palbociclib
ribociclib
venous thromboembolism
Journal
Journal of thrombosis and haemostasis : JTH
ISSN: 1538-7836
Titre abrégé: J Thromb Haemost
Pays: England
ID NLM: 101170508
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
09
05
2019
accepted:
27
08
2019
pubmed:
4
9
2019
medline:
15
5
2021
entrez:
4
9
2019
Statut:
ppublish
Résumé
Venous thromboembolism (VTE) complicates several anticancer regimens including chemotherapy and antiangiogenic agents. Cyclin-dependent kinase inhibitors (CDKIs) are a new approach for hormone receptor-positive metastatic breast cancer (mBC). Reported VTE rates in randomized trials range from 0.6% to 5%, but these may underestimate actual rates observed in clinical practice. Evaluate VTE rate and its association with outcomes in CDKIs patients. We conducted a retrospective cohort study of consecutive mBC patients who received any of three Food and Drug Administration (FDA)-approved CDKIs (palbociclib, ribociclib, abemaciclib) from January 2015 through December 2017. Venous thromboembolism including deep venous thrombosis (DVT), pulmonary embolism (PE), and visceral vein thrombosis (VVT) were identified by electronic medical record review. Overall survival (OS) and progression-free survival (PFS) were estimated and evaluated for association with VTE using Cox proportional hazard regression. We included 424 patients, with a median age at diagnosis of 55 years. Palbociclib was the most commonly used CDKI (n = 390, 91.8%). Venous thromboembolism during CDKIs occurred in 38 patients, 6.3% at year 1, including DVT in 52.6%, PE in 18.5%, and VVT in 15.8%. Median time to VTE was 314 days. Venous thromboembolism was associated with a trend to worse PFS and OS in multivariate analysis [PFS hazard ratio (HR) 1.40, 95% confidence interval (CI) 0.83-2.38, P = .21], OS (HR 1.70, 95% CI 0.95-2.98, P = .076). Venous thromboembolism rates with CDKI treatment in mBC in clinical practice are 2-fold to 5-fold greater than reported in registration trials and may be associated with worse outcomes.
Sections du résumé
BACKGROUND
Venous thromboembolism (VTE) complicates several anticancer regimens including chemotherapy and antiangiogenic agents. Cyclin-dependent kinase inhibitors (CDKIs) are a new approach for hormone receptor-positive metastatic breast cancer (mBC). Reported VTE rates in randomized trials range from 0.6% to 5%, but these may underestimate actual rates observed in clinical practice.
OBJECTIVES
Evaluate VTE rate and its association with outcomes in CDKIs patients.
PATIENTS/METHODS
We conducted a retrospective cohort study of consecutive mBC patients who received any of three Food and Drug Administration (FDA)-approved CDKIs (palbociclib, ribociclib, abemaciclib) from January 2015 through December 2017. Venous thromboembolism including deep venous thrombosis (DVT), pulmonary embolism (PE), and visceral vein thrombosis (VVT) were identified by electronic medical record review. Overall survival (OS) and progression-free survival (PFS) were estimated and evaluated for association with VTE using Cox proportional hazard regression.
RESULTS
We included 424 patients, with a median age at diagnosis of 55 years. Palbociclib was the most commonly used CDKI (n = 390, 91.8%). Venous thromboembolism during CDKIs occurred in 38 patients, 6.3% at year 1, including DVT in 52.6%, PE in 18.5%, and VVT in 15.8%. Median time to VTE was 314 days. Venous thromboembolism was associated with a trend to worse PFS and OS in multivariate analysis [PFS hazard ratio (HR) 1.40, 95% confidence interval (CI) 0.83-2.38, P = .21], OS (HR 1.70, 95% CI 0.95-2.98, P = .076).
CONCLUSIONS
Venous thromboembolism rates with CDKI treatment in mBC in clinical practice are 2-fold to 5-fold greater than reported in registration trials and may be associated with worse outcomes.
Identifiants
pubmed: 31479568
doi: 10.1111/jth.14630
pii: S1538-7836(22)01567-7
doi:
Substances chimiques
Protein Kinase Inhibitors
0
Cyclin-Dependent Kinases
EC 2.7.11.22
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
162-168Informations de copyright
© 2019 International Society on Thrombosis and Haemostasis.
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