A QA Program for MRD Testing Demonstrates That Systematic Education Can Reduce Discordance Among Experienced Interpreters

Minimal residual disease (MRD) in B lymphoblastic leukemia (B‐ALL) by flow cytometry is an established prognostic factor used to adjust treatment in most pediatric therapeutic protocols. MRD in B‐ALL has been standardized by the Children's Oncology Group (COG) in North America, but not routine clinical labs. The Foundation for National Institutes of Health sought to harmonize MRD measurement among COG, oncology groups, academic, community and government, laboratories.

[1]  Jeremy Hancock,et al.  Establishment and validation of a standard protocol for the detection of minimal residual disease in B lineage childhood acute lymphoblastic leukemia by flow cytometry in a multi-center setting; , 2009, Haematologica.

[2]  Giuseppe Basso,et al.  Standardization of flow cytometric minimal residual disease evaluation in acute lymphoblastic leukemia: Multicentric assessment is feasible , 2008, Cytometry. Part B, Clinical cytometry.

[3]  S. Hunger,et al.  Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study. , 2008, Blood.

[4]  Quentin Lecrevisse,et al.  Standardized flow cytometry for highly sensitive MRD measurements in B-cell acute lymphoblastic leukemia. , 2017, Blood.

[5]  Prognostic value of minimal residual disease in acute lymphoblastic leukaemia in childhood , 1998 .

[6]  Teri Oldaker,et al.  Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part I – rationale and aims , 2013, Cytometry. Part B, Clinical cytometry.

[7]  M. Loh,et al.  Prognostic significance of minimal residual disease in high risk B-ALL: a report from Children's Oncology Group study AALL0232. , 2015, Blood.

[8]  E. Giné,et al.  Fludarabine, Cyclophosphamide, and Mitoxantrone as Initial Therapy of Chronic Lymphocytic Leukemia: High Response Rate and Disease Eradication , 2008, Clinical Cancer Research.

[9]  Elaine Coustan-Smith,et al.  A simplified flow cytometric assay identifies children with acute lymphoblastic leukemia who have a superior clinical outcome. , 2006, Blood.

[10]  L. Palmqvist,et al.  Minimal residual disease monitoring in childhood B lymphoblastic leukemia with t(12;21)(p13;q22); ETV6–RUNX1: concordant results using quantitation of fusion transcript and flow cytometry , 2017, International journal of laboratory hematology.

[11]  A. Órfão,et al.  BIOMED-I concerted action report: flow cytometric immunophenotyping of precursor B-ALL with standardized triple-stainings. BIOMED-1 Concerted Action Investigation of Minimal Residual Disease in Acute Leukemia: International Standardization and Clinical Evaluation. , 2001, Leukemia.

[12]  R. Pieters,et al.  Standardized MRD quantification in European ALL trials: Proceedings of the Second International Symposium on MRD assessment in Kiel, Germany, 18–20 September 2008 , 2010, Leukemia.

[13]  D. Barnett,et al.  Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part IV – postanalytic considerations , 2013, Cytometry. Part B, Clinical cytometry.

[14]  A. Órfão,et al.  Multiparameter flow cytometric remission is the most relevant prognostic factor for multiple myeloma patients who undergo autologous stem cell transplantation. , 2008, Blood.

[15]  M. Borowitz,et al.  Comparison of diagnostic and relapse flow cytometry phenotypes in childhood acute lymphoblastic leukemia: Implications for residual disease detection: A report from the children's oncology group , 2005, Cytometry. Part B, Clinical cytometry.

[16]  Jin-Yeong Han,et al.  Validation of cell‐based fluorescence assays: practice guidelines from the ICSH and ICCS – part II – preanalytical issues , 2013, Cytometry. Part B, Clinical cytometry.

[17]  A. Órfão,et al.  Minimal residual disease monitoring and immune profiling in multiple myeloma in elderly patients. , 2016, Blood.

[18]  A. Porwit,et al.  Quality Control of Flow Cytometry Data Analysis for Evaluation of Minimal Residual Disease in Bone Marrow From Acute Leukemia Patients During Treatment , 2009, Journal of pediatric hematology/oncology.

[19]  A Orfao,et al.  EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes , 2012, Leukemia.

[20]  Michael N Dworzak,et al.  Prognostic significance and modalities of flow cytometric minimal residual disease detection in childhood acute lymphoblastic leukemia. , 2002, Blood.

[21]  F. Lo‐Coco,et al.  Prognostic and therapeutic implications of minimal residual disease detection in acute myeloid leukemia. , 2012, Blood.

[22]  R. Arceci,et al.  Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study , 2009 .

[23]  Maria Grazia Valsecchi,et al.  Time point-dependent concordance of flow cytometry and real-time quantitative polymerase chain reaction for minimal residual disease detection in childhood acute lymphoblastic leukemia , 2012, Haematologica.

[24]  Dana Pe'er,et al.  PhenoGraph and viSNE facilitate the identification of abnormal T‐cell populations in routine clinical flow cytometric data , 2018, Cytometry. Part B, Clinical cytometry.

[25]  A. Rawstron,et al.  Minimal residual disease assessment in chronic lymphocytic leukaemia. , 2007, Best practice & research. Clinical haematology.

[26]  S. Gujral,et al.  CD19 negative precursor B acute lymphoblastic leukemia (B‐ALL)—Immunophenotypic challenges in diagnosis and monitoring: A study of three cases , 2017, Cytometry. Part B, Clinical cytometry.

[27]  Ming Yan,et al.  Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part V – assay performance criteria , 2013, Cytometry. Part B, Clinical cytometry.

[28]  A. Porwit,et al.  Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part III – analytical issues , 2013, Cytometry. Part B, Clinical cytometry.

[29]  R. Wade,et al.  Use of Minimal Residual Disease Assessment to Redefine Induction Failure in Pediatric Acute Lymphoblastic Leukemia. , 2017, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[30]  M. Stetler-Stevenson,et al.  Flow Cytometric Monitoring for Residual Disease in B Lymphoblastic Leukemia Post T Cell Engaging Targeted Therapies , 2018, Current protocols in cytometry.

[31]  Dario Campana,et al.  Minimal residual disease-guided therapy in childhood acute lymphoblastic leukemia. , 2017, Blood.

[32]  W. Hop,et al.  Prognostic value of minimal residual disease in acute lymphoblastic leukaemia in childhood , 1998, The Lancet.

[33]  C. Mosse,et al.  B-ALL minimal residual disease flow cytometry: an application of a novel method for optimization of a single-tube model. , 2015, American journal of clinical pathology.

[34]  C. Hourigan,et al.  MRD evaluation of AML in clinical practice: are we there yet? , 2019, Hematology. American Society of Hematology. Education Program.

[35]  J. V. van Dongen,et al.  Immunophenotypic changes between diagnosis and relapse in childhood acute lymphoblastic leukemia. , 1995, Leukemia.

[36]  H. Sather,et al.  Treatment of higher risk acute lymphoblastic leukemia in young people (CCG-1961), long-term follow-up: a report from the Children’s Oncology Group , 2019, Leukemia.

[37]  A Orfao,et al.  EuroFlow: Resetting leukemia and lymphoma immunophenotyping. Basis for companion diagnostics and personalized medicine , 2012, Leukemia.

[38]  Weina Chen,et al.  Minimal/Measurable Residual Disease Detection in Acute Leukemias by Multiparameter Flow Cytometry , 2018, Current Hematologic Malignancy Reports.

[39]  T. Kalina,et al.  EuroFlow standardization of flow cytometer instrument settings and immunophenotyping protocols , 2012, Leukemia.

[40]  Barbara Buldini,et al.  Minimal residual disease analysis by eight-color flow cytometry in relapsed childhood acute lymphoblastic leukemia , 2015, Haematologica.

[41]  J. Lahuerta,et al.  Evaluation of minimal residual disease in multiple myeloma patients by fluorescent‐polymerase chain reaction: the prognostic impact of achieving molecular response , 2008, British journal of haematology.

[42]  H. Gadner,et al.  Detection of Residual Disease in Pediatric B-Cell Precursor Acute Lymphoblastic Leukemia by Comparative Phenotype Mapping: Method and Significance , 2000, Leukemia & lymphoma.

[43]  E. Weir,et al.  A limited antibody panel can distinguish B-precursor acute lymphoblastic leukemia from normal B precursors with four color flow cytometry: implications for residual disease detection , 1999, Leukemia.

[44]  H. Maecker,et al.  Selecting fluorochrome conjugates for maximum sensitivity , 2004, Cytometry. Part A : the journal of the International Society for Analytical Cytology.