Repository logo
 

Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features.

Published version
Peer-reviewed

Type

Article

Change log

Authors

Godfrey, Anna L 
Campbell, Peter J 
MacLean, Cathy 
Buck, Georgina 
Cook, Julia 

Abstract

PURPOSE: Cytoreductive therapy is beneficial in patients with essential thrombocythemia (ET) at high risk of thrombosis. However, its value in those lacking high-risk features remains unknown. This open-label, randomized trial compared hydroxycarbamide plus aspirin with aspirin alone in patients with ET age 40 to 59 years and without high-risk factors or extreme thrombocytosis. PATIENTS AND METHODS: Patients were age 40 to 59 years and lacked a history of ischemia, thrombosis, embolism, hemorrhage, extreme thrombocytosis (platelet count ≥ 1,500 × 109/L), hypertension, or diabetes requiring therapy. In all, 382 patients were randomly assigned 1:1 to hydroxycarbamide plus aspirin or aspirin alone. The composite primary end point was time to arterial or venous thrombosis, serious hemorrhage, or death from vascular causes. Secondary end points were time to first arterial or venous thrombosis, first serious hemorrhage, death, incidence of transformation, and patient-reported quality of life. RESULTS: After a median follow-up of 73 months and a total follow-up of 2,373 patient-years, there was no significant difference between the arms in the likelihood of patients reaching the primary end point (hazard ratio, 0.98; 95% CI, 0.42 to 2.25; P = 1.0). The incidence of significant vascular events was low, at 0.93 per 100 patient-years (95% CI, 0.61 to 1.41). There were also no differences in overall survival; in the composite end point of transformation to myelofibrosis, acute myeloid leukemia, or myelodysplasia; in adverse events; or in patient-reported quality of life. CONCLUSION: In patients with ET age 40 to 59 years and lacking high-risk factors for thrombosis or extreme thrombocytosis, preemptive addition of hydroxycarbamide to aspirin did not reduce vascular events, myelofibrotic transformation, or leukemic transformation. Patients age 40 to 59 years without other clinical indications for treatment (such as previous thrombosis or hemorrhage) who have a platelet count < 1,500 × 109/L should not receive cytoreductive therapy.

Description

Keywords

Adult, Aspirin, Australia, Disease Progression, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, France, Humans, Hydroxyurea, Internationality, Ireland, Janus Kinase 2, Kaplan-Meier Estimate, Male, Middle Aged, New Zealand, Prognosis, Proportional Hazards Models, Prospective Studies, Risk Assessment, Severity of Illness Index, Thrombocythemia, Essential, Thrombosis, Treatment Outcome, United Kingdom

Journal Title

J Clin Oncol

Conference Name

Journal ISSN

0732-183X
1527-7755

Volume Title

36

Publisher

American Society of Clinical Oncology (ASCO)
Sponsorship
Medical Research Council (MC_PC_12009)
Cancer Research UK (21762)
Cancer Research UK (23917)
Supported by the Medical Research Council, UK, Cancer Research UK, the French National Cancer Institute (INCa), Bloodwise, the Wellcome Trust, the Kay Kendall Leukaemia Fund, and the Leukemia and Lymphoma Society of America