Abstract
Presence of minimal residual disease (MRD), detected by flow cytometry, is an important prognostic biomarker in the management of B-cell precursor acute lymphoblastic leukemia (BCP-ALL). However, data-analysis remains mainly expert-dependent. In this study, we designed and validated an Automated Gating & Identification (AGI) tool for MRD analysis in BCP-ALL patients using the two tubes of the EuroFlow 8-color MRD panel. The accuracy, repeatability, and reproducibility of the AGI tool was validated in a multicenter study using bone marrow follow-up samples from 174 BCP-ALL patients, stained with the EuroFlow BCP-ALL MRD panel. In these patients, MRD was assessed both by manual analysis and by AGI tool supported analysis. Comparison of MRD levels obtained between both approaches showed a concordance rate of 83%, with comparable concordances between MRD tubes (tube 1, 2 or both), treatment received (chemotherapy versus targeted therapy) and flow cytometers (FACSCanto versus FACSLyric). After review of discordant cases by additional experts, the concordance increased to 97%. Furthermore, the AGI tool showed excellent intra-expert concordance (100%) and good inter-expert concordance (90%). In addition to MRD levels, also percentages of normal cell populations showed excellent concordance between manual and AGI tool analysis. We conclude that the AGI tool may facilitate MRD analysis using the EuroFlow BCP-ALL MRD protocol and will contribute to a more standardized and objective MRD assessment. However, appropriate training is required for the correct analysis of MRD data.
Original language | English |
---|---|
Pages (from-to) | 252-263 |
Number of pages | 12 |
Journal | Cytometry Part B - Clinical Cytometry |
Volume | 106 |
Issue number | 4 |
Early online date | 22 Sept 2023 |
DOIs | |
Publication status | Published - Jul 2024 |
Bibliographical note
FUNDING INFORMATION:The EuroFlow Consortium received support from the
FP6-2004-LIFESCIHEALTH-5 program of the European Commission
(grant LSHB-CT-2006-018708) as Specific Targeted Research Project
(STREP). The EuroFlow Consortium is part of the European Scientific
Foundation for Hemato-Oncology (ESLHO), a Scientific Working
Group (SWG) of the European Hematology Association (EHA). This
study has been funded by the CB16/12/00400 (CIBERONC) and
PI19/01183 grants, by Instituto de Salud Carlos III (ISCIII) and cofunded by the Fondo Europeo de Desarrollo Regional (FEDER). MR
and EM were supported by the Ministry of Health of the
Czech Republic, grant number NU20J-07-00028. EM was further
supported by the National Institute for Cancer Research (Programme
EXCELES, ID Project No. LX22NPO5102)—Funded by the European
Union—Next Generation EU. MoBr was supported by the Deutsche
José Carreras Leukämie-Stiftung (grants DJCLS R 15/11 and DJCLS
06R/2019). LuSe, LuSl and TS were supported by internal grant from
the Medical Univeristy of Silesia: PCN-1-075/K/1/K. CB and GiGa
were partially supported by Fondazione M. Tettamanti M. De Marchi
ONLUS for this project.
Publisher Copyright:
© 2023 The Authors. Cytometry Part B: Clinical Cytometry published by Wiley Periodicals LLC on behalf of International Clinical Cytometry Society.