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Risk prediction for clonal cytopenia: multicenter real-world evidence.

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Clonal cytopenia of undetermined significance (CCUS) can progress to myeloid neoplasm (MN). The new Clonal Cytopenia Risk Score (CCRS) effectively predicts this progression risk using clinical and molecular factors.

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Area of Science:

  • Hematology
  • Oncology
  • Genetics

Background:

  • Clonal cytopenia of undetermined significance (CCUS) is defined by myeloid-related somatic mutations in individuals with unexplained cytopenias.
  • CCUS carries a risk of progression to myeloid neoplasm (MN), especially with high-risk mutations.
  • Dedicated studies are needed to understand CCUS risk factors and natural history.

Purpose of the Study:

  • To investigate the interplay between clonality, cytopenia, and prognosis in CCUS patients.
  • To develop and validate a risk score for predicting CCUS progression to MN.

Main Methods:

  • Analysis of 357 patients with CCUS to identify prognostic factors.
  • Multivariate analysis using Cox proportional hazards model to determine adverse prognostic factors.
  • Development of the Clonal Cytopenia Risk Score (CCRS) based on identified factors.
  • Validation of CCRS in an independent cohort of 104 CCUS patients.

Main Results:

  • Three key adverse prognostic factors identified: splicing mutations (2 points), platelet count <100 × 10^9/L (2.5 points), and ≥2 mutations (3 points).
  • The CCRS stratified patients into low (<2.5), intermediate (2.5 to <5), and high (≥5) risk groups.
  • CCRS accurately predicted 2-year cumulative incidence of MN: 6.4% (low), 14.1% (intermediate), and 37.2% (high risk) (P < .0001).
  • Validation cohort showed a c-index of 0.64 (P = .005) for MN cumulative incidence stratification.

Conclusions:

  • The CCRS is a practical and calculable tool for assessing CCUS progression risk.
  • Integrating clinical and molecular data is crucial for managing CCUS.
  • Findings will inform CCUS management strategies and clinical trial designs.