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PV-ARC: ELN Clinical Signs and Symptoms for thrombotic risk in patients with PV treated with HU

By Dylan Barrett

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Jan 10, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in polycythemia vera.



The observational, longitudinal, retrospective, and prospective PV-ARC study (NCT06134102) aimed to investigate the impact of clinical and laboratory characteristics of PV on patients prognoses.1 A sub-analysis from the study presented during the 66th ASH Annual Meeting and Exposition by Palandri assessed the incidence of thrombosis among 739 patients with PV treated with first-line hydroxyurea (HU), and the impact of the ELN 2021 criteria for initiating cytoreductive therapy.1


Key learnings
The IRR of thrombosis was higher in HR-THRO patients (3.0) vs LR-patients (1.1; p = 0.006) and HR-AGE patients (1.3; p = 0.002); within the HR-THRO group, IRR was highest in patients with both older age and previous thrombosis (3.5) vs thrombosis only (1.9).
Patients with no ELN CSSs had improved 5-year TFS vs patients with ELN CSSs across risk groups (LR, 100% vs 86.4; HR-AGE, 97.8% vs 91.4%; HR-THRO, 88.1% vs 79.5%).
Progressive splenomegaly (HR, 6.10; 95% CI, 1.70–21.88; p = 0.005), inadequate hematocrit control (HR, 2.20; 95% CI, 1.36–3.54; p = 0.001), and relevant CVRFs (HR, 2.56; 95% CI, 1.09–6.00; p = 0.03) were significant predictors of thrombotic risk and may be used to inform more aggressive and personalized management strategies.
Results suggested that ELN CSSs can identify patients with PV at increased thrombotic risk across all conventional risk categories. 

Abbreviations: ASH, American Society of Hematology; CI, confidence interval; CSSs, Clinical Signs and Symptoms; CVRF, cardiovascular risk factor; ELN, European LeukemiaNet; HR, hazard ratio; HR-AGE, high-risk, age >60 years; HR-THRO, high-risk, previous thrombosis; IRR, incidence ratio rate; LR, low-risk; PV, polycythemia vera.

References

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