4.7 Article

Post-induction MRD by FCM and GATA1-PCR are significant prognostic factors for myeloid leukemia of Down syndrome

Journal

LEUKEMIA
Volume 35, Issue 9, Pages 2508-2516

Publisher

SPRINGERNATURE
DOI: 10.1038/s41375-021-01157-w

Keywords

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Funding

  1. Ministry of Health, Labour, and Welfare of Japan
  2. Japan Agency for Medical Research and Development (AMED) [JP19lk0201061t0004, JP19ck0106329]
  3. Ministry of Education, Culture, Sports, Science, and Technology of Japan [KAKENHI: 26253061, 18H04039]
  4. Grants-in-Aid for Scientific Research [18H04039] Funding Source: KAKEN

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In patients with ML-DS, detection of MRD after induction therapy, either by FCM or GATA1, was significantly associated with three-year event-free survival and overall survival rates. Positive MRD results were predictive of a higher risk of relapse in ML-DS patients.
Myeloid leukemia of Down syndrome (ML-DS) is associated with good response to chemotherapy, resulting in favorable outcomes. However, no universal prognostic factors have been identified to date. To clarify a subgroup with high risk of relapse, the role of minimal residual disease (MRD) was explored in the AML-D11 trial by the Japanese Pediatric Leukemia/Lymphoma Study Group. MRD was prospectively evaluated at after induction therapy and at the end of all chemotherapy, using flow cytometry (FCM-MRD) and GATA1-targeted deep sequencing (GATA1-MRD). A total of 78 patients were eligible and 76 patients were stratified to the standard risk (SR) group by morphology. In SR patients, FCM-MRD and GATA1-MRD after induction were positive in 5/65 and 7/59 patients, respectively. Three-year event-free survival (EFS) and overall survival (OS) rates were 93.3% and 95.0% in the FCM-MRD-negative population, and 60.0% and 80.0% in the positive population. Three-year EFS and OS rates were both 96.2% in the GATA1-MRD-negative population, and 57.1% and 71.4% in the positive population. Adjusted hazard ratios for associations of FCM-MRD or GATA1-MRD with EFS were 10.98 (p = 0.01) and 27.68 (p < 0.01), respectively. Detection of MRD by either FCM or GATA1 after initial induction therapy represents a significant prognostic factor for predicting ML-DS relapse.

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