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

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Anna L Godfreythe Australasian Leukaemia and Lymphoma Group.

Abstract

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 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. 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 signific...Continue Reading

Associated Clinical Trials

Sep 15, 2005·Anthony Green

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Feb 23, 2019·Expert Review of Hematology·Barbara Mora, Francesco Passamonti
Jan 25, 2020·Blood Advances·Brianna M CraverAngela G Fleischman
Sep 26, 2020·American Journal of Hematology·Ayalew Tefferi, Tiziano Barbui
Apr 22, 2021·HemaSphere·Andrew J Robinson, Anna L Godfrey
Aug 4, 2021·British Journal of Haematology·Eun Y HanMary F McMullin
Aug 20, 2021·British Journal of Haematology·Nicholas C P CrossUNKNOWN A British Society for Haematology Good Practice Paper
Sep 4, 2021·HemaSphere·Hartmut DöhnerAgnieszka Wierzbowska
Sep 30, 2021·Current Hematologic Malignancy Reports·Tiziano Barbui, Valerio De Stefano
Oct 8, 2021·Arteriosclerosis, Thrombosis, and Vascular Biology·Sally Thomas, Anandi Krishnan
Oct 28, 2021·Experimental Hematology·Tony Green

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Methods Mentioned

BETA
biopsy
MDS

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