ERIC recommendations for TP53 mutation analysis in chronic lymphocytic leukemia—2024 update

In chronic lymphocytic leukemia (CLL), analysis of TP53 aberrations (deletion and/or mutation) is a crucial part of treatment decision-making algorithms. Technological and treatment advances have resulted in the need for an update of the last recommendations for TP53 analysis in CLL, published by ER...

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Published inLeukemia Vol. 38; no. 7; pp. 1455 - 1468
Main Authors Malcikova, Jitka, Pavlova, Sarka, Baliakas, Panagiotis, Chatzikonstantinou, Thomas, Tausch, Eugen, Catherwood, Mark, Rossi, Davide, Soussi, Thierry, Tichy, Boris, Kater, Arnon P., Niemann, Carsten U., Davi, Frederic, Gaidano, Gianluca, Stilgenbauer, Stephan, Rosenquist, Richard, Stamatopoulos, Kostas, Ghia, Paolo, Pospisilova, Sarka
Format Journal Article
LanguageEnglish
Published London Nature Publishing Group UK 01.07.2024
Nature Publishing Group
Subjects
45/23
631/67/395
692/499
Aberration
Algorithms
Cancer Research
Chronic lymphocytic leukemia
Clinical trials
Cloning
Critical Care Medicine
Decision making
DNA Mutational Analysis - methods
DNA Mutational Analysis - standards
Gene deletion
Gene frequency
Health services
Hematology
High-Throughput Nucleotide Sequencing - methods
Humans
Intensive
Internal Medicine
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell - diagnosis
Leukemia, Lymphocytic, Chronic, B-Cell - genetics
Medicine
Medicine & Public Health
Mutation
Next-generation sequencing
Oncology
p53 Protein
Patients
Review
Review Article
Risk reduction
Tumor Suppressor Protein p53 - genetics
Online AccessGet full text
ISSN0887-6924
1476-5551
1476-5551
DOI10.1038/s41375-024-02267-x

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Abstract In chronic lymphocytic leukemia (CLL), analysis of TP53 aberrations (deletion and/or mutation) is a crucial part of treatment decision-making algorithms. Technological and treatment advances have resulted in the need for an update of the last recommendations for TP53 analysis in CLL, published by ERIC, the European Research Initiative on CLL, in 2018. Based on the current knowledge of the relevance of low-burden TP53 -mutated clones, a specific variant allele frequency (VAF) cut-off for reporting TP53 mutations is no longer recommended, but instead, the need for thorough method validation by the reporting laboratory is emphasized. The result of TP53 analyses should always be interpreted within the context of available laboratory and clinical information, treatment indication, and therapeutic options. Methodological aspects of introducing next-generation sequencing (NGS) in routine practice are discussed with a focus on reliable detection of low-burden clones. Furthermore, potential interpretation challenges are presented, and a simplified algorithm for the classification of TP53 variants in CLL is provided, representing a consensus based on previously published guidelines. Finally, the reporting requirements are highlighted, including a template for clinical reports of TP53 aberrations. These recommendations are intended to assist diagnosticians in the correct assessment of TP53 mutation status, but also physicians in the appropriate understanding of the lab reports, thus decreasing the risk of misinterpretation and incorrect management of patients in routine practice whilst also leading to improved stratification of patients with CLL in clinical trials.
AbstractList In chronic lymphocytic leukemia (CLL), analysis of TP53 aberrations (deletion and/or mutation) is a crucial part of treatment decision-making algorithms. Technological and treatment advances have resulted in the need for an update of the last recommendations for TP53 analysis in CLL, published by ERIC, the European Research Initiative on CLL, in 2018. Based on the current knowledge of the relevance of low-burden TP53 -mutated clones, a specific variant allele frequency (VAF) cut-off for reporting TP53 mutations is no longer recommended, but instead, the need for thorough method validation by the reporting laboratory is emphasized. The result of TP53 analyses should always be interpreted within the context of available laboratory and clinical information, treatment indication, and therapeutic options. Methodological aspects of introducing next-generation sequencing (NGS) in routine practice are discussed with a focus on reliable detection of low-burden clones. Furthermore, potential interpretation challenges are presented, and a simplified algorithm for the classification of TP53 variants in CLL is provided, representing a consensus based on previously published guidelines. Finally, the reporting requirements are highlighted, including a template for clinical reports of TP53 aberrations. These recommendations are intended to assist diagnosticians in the correct assessment of TP53 mutation status, but also physicians in the appropriate understanding of the lab reports, thus decreasing the risk of misinterpretation and incorrect management of patients in routine practice whilst also leading to improved stratification of patients with CLL in clinical trials.
In chronic lymphocytic leukemia (CLL), analysis of TP53 aberrations (deletion and/or mutation) is a crucial part of treatment decision-making algorithms. Technological and treatment advances have resulted in the need for an update of the last recommendations for TP53 analysis in CLL, published by ERIC, the European Research Initiative on CLL, in 2018. Based on the current knowledge of the relevance of low-burden TP53-mutated clones, a specific variant allele frequency (VAF) cut-off for reporting TP53 mutations is no longer recommended, but instead, the need for thorough method validation by the reporting laboratory is emphasized. The result of TP53 analyses should always be interpreted within the context of available laboratory and clinical information, treatment indication, and therapeutic options. Methodological aspects of introducing next-generation sequencing (NGS) in routine practice are discussed with a focus on reliable detection of low-burden clones. Furthermore, potential interpretation challenges are presented, and a simplified algorithm for the classification of TP53 variants in CLL is provided, representing a consensus based on previously published guidelines. Finally, the reporting requirements are highlighted, including a template for clinical reports of TP53 aberrations. These recommendations are intended to assist diagnosticians in the correct assessment of TP53 mutation status, but also physicians in the appropriate understanding of the lab reports, thus decreasing the risk of misinterpretation and incorrect management of patients in routine practice whilst also leading to improved stratification of patients with CLL in clinical trials.In chronic lymphocytic leukemia (CLL), analysis of TP53 aberrations (deletion and/or mutation) is a crucial part of treatment decision-making algorithms. Technological and treatment advances have resulted in the need for an update of the last recommendations for TP53 analysis in CLL, published by ERIC, the European Research Initiative on CLL, in 2018. Based on the current knowledge of the relevance of low-burden TP53-mutated clones, a specific variant allele frequency (VAF) cut-off for reporting TP53 mutations is no longer recommended, but instead, the need for thorough method validation by the reporting laboratory is emphasized. The result of TP53 analyses should always be interpreted within the context of available laboratory and clinical information, treatment indication, and therapeutic options. Methodological aspects of introducing next-generation sequencing (NGS) in routine practice are discussed with a focus on reliable detection of low-burden clones. Furthermore, potential interpretation challenges are presented, and a simplified algorithm for the classification of TP53 variants in CLL is provided, representing a consensus based on previously published guidelines. Finally, the reporting requirements are highlighted, including a template for clinical reports of TP53 aberrations. These recommendations are intended to assist diagnosticians in the correct assessment of TP53 mutation status, but also physicians in the appropriate understanding of the lab reports, thus decreasing the risk of misinterpretation and incorrect management of patients in routine practice whilst also leading to improved stratification of patients with CLL in clinical trials.
In chronic lymphocytic leukemia (CLL), analysis of TP53 aberrations (deletion and/or mutation) is a crucial part of treatment decision-making algorithms. Technological and treatment advances have resulted in the need for an update of the last recommendations for TP53 analysis in CLL, published by ERIC, the European Research Initiative on CLL, in 2018. Based on the current knowledge of the relevance of low-burden TP53-mutated clones, a specific variant allele frequency (VAF) cut-off for reporting TP53 mutations is no longer recommended, but instead, the need for thorough method validation by the reporting laboratory is emphasized. The result of TP53 analyses should always be interpreted within the context of available laboratory and clinical information, treatment indication, and therapeutic options. Methodological aspects of introducing next-generation sequencing (NGS) in routine practice are discussed with a focus on reliable detection of low-burden clones. Furthermore, potential interpretation challenges are presented, and a simplified algorithm for the classification of TP53 variants in CLL is provided, representing a consensus based on previously published guidelines. Finally, the reporting requirements are highlighted, including a template for clinical reports of TP53 aberrations. These recommendations are intended to assist diagnosticians in the correct assessment of TP53 mutation status, but also physicians in the appropriate understanding of the lab reports, thus decreasing the risk of misinterpretation and incorrect management of patients in routine practice whilst also leading to improved stratification of patients with CLL in clinical trials.
Author Stamatopoulos, Kostas
Tichy, Boris
Kater, Arnon P.
Niemann, Carsten U.
Pospisilova, Sarka
Pavlova, Sarka
Stilgenbauer, Stephan
Gaidano, Gianluca
Rosenquist, Richard
Rossi, Davide
Tausch, Eugen
Malcikova, Jitka
Chatzikonstantinou, Thomas
Davi, Frederic
Soussi, Thierry
Catherwood, Mark
Baliakas, Panagiotis
Ghia, Paolo
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Snippet In chronic lymphocytic leukemia (CLL), analysis of TP53 aberrations (deletion and/or mutation) is a crucial part of treatment decision-making algorithms....
In chronic lymphocytic leukemia (CLL), analysis of TP53 aberrations (deletion and/or mutation) is a crucial part of treatment decision-making algorithms....
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SubjectTerms 45/23
631/67/395
692/499
Aberration
Algorithms
Cancer Research
Chronic lymphocytic leukemia
Clinical trials
Cloning
Critical Care Medicine
Decision making
DNA Mutational Analysis - methods
DNA Mutational Analysis - standards
Gene deletion
Gene frequency
Health services
Hematology
High-Throughput Nucleotide Sequencing - methods
Humans
Intensive
Internal Medicine
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell - diagnosis
Leukemia, Lymphocytic, Chronic, B-Cell - genetics
Medicine
Medicine & Public Health
Mutation
Next-generation sequencing
Oncology
p53 Protein
Patients
Review
Review Article
Risk reduction
Tumor Suppressor Protein p53 - genetics
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Title ERIC recommendations for TP53 mutation analysis in chronic lymphocytic leukemia—2024 update
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