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

Research output: Contribution to journalArticlepeer-review

Standard

Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features. / Godfrey, A. L.; Campbell, P. J.; MacLean, Cathy; Buck, G.; Cook, J.; Temple, J.; Wilkins, B. S.; Wheatley, Keith; Nangalia, J.; Grinfeld, J.; McMullin, M. F.; Forsyth, C.; Kiladjian, J. J.; Green, A. R.; Harrison, C. N.

In: Journal of Clinical Oncology , 28.08.2018.

Research output: Contribution to journalArticlepeer-review

Harvard

Godfrey, AL, Campbell, PJ, MacLean, C, Buck, G, Cook, J, Temple, J, Wilkins, BS, Wheatley, K, Nangalia, J, Grinfeld, J, McMullin, MF, Forsyth, C, Kiladjian, JJ, Green, AR & Harrison, CN 2018, 'Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features', Journal of Clinical Oncology . https://doi.org/10.1200/JCO.2018.78.8414

APA

Godfrey, A. L., Campbell, P. J., MacLean, C., Buck, G., Cook, J., Temple, J., Wilkins, B. S., Wheatley, K., Nangalia, J., Grinfeld, J., McMullin, M. F., Forsyth, C., Kiladjian, J. J., Green, A. R., & Harrison, C. N. (2018). Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features. Journal of Clinical Oncology . https://doi.org/10.1200/JCO.2018.78.8414

Vancouver

Author

Godfrey, A. L. ; Campbell, P. J. ; MacLean, Cathy ; Buck, G. ; Cook, J. ; Temple, J. ; Wilkins, B. S. ; Wheatley, Keith ; Nangalia, J. ; Grinfeld, J. ; McMullin, M. F. ; Forsyth, C. ; Kiladjian, J. J. ; Green, A. R. ; Harrison, C. N. / Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features. In: Journal of Clinical Oncology . 2018.

Bibtex

@article{04d1ad8c0cab4eea8789d6360144e4a3,
title = "Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features",
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.",
author = "Godfrey, {A. L.} and Campbell, {P. J.} and Cathy MacLean and G. Buck and J. Cook and J. Temple and Wilkins, {B. S.} and Keith Wheatley and J. Nangalia and J. Grinfeld and McMullin, {M. F.} and C. Forsyth and Kiladjian, {J. J.} and Green, {A. R.} and Harrison, {C. N.}",
year = "2018",
month = aug,
day = "28",
doi = "10.1200/JCO.2018.78.8414",
language = "English",
journal = "Journal of Clinical Oncology ",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",

}

RIS

TY - JOUR

T1 - Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features

AU - Godfrey, A. L.

AU - Campbell, P. J.

AU - MacLean, Cathy

AU - Buck, G.

AU - Cook, J.

AU - Temple, J.

AU - Wilkins, B. S.

AU - Wheatley, Keith

AU - Nangalia, J.

AU - Grinfeld, J.

AU - McMullin, M. F.

AU - Forsyth, C.

AU - Kiladjian, J. J.

AU - Green, A. R.

AU - Harrison, C. N.

PY - 2018/8/28

Y1 - 2018/8/28

N2 - 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.

AB - 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.

U2 - 10.1200/JCO.2018.78.8414

DO - 10.1200/JCO.2018.78.8414

M3 - Article

C2 - 30153096

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

ER -