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PV-ARC: ELN Clinical Signs and Symptoms for thrombotic risk in patients with PV treated with HU
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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.
- Palandri F. Revised ELN criteria in polycythemia vera identify an increased risk phenotype for thrombotic events beyond conventional risk stratification. A multicenter cooperative study. Oral abstract #242. Presented at: 66th American Society of Hematology Annual Meeting and Exposition; Dec 7–10, 2024; San Diego, US.
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