Updated Diagnostic Criteria and Classification of Mast Cell Disorders: A Consensus Proposal
Open accessAbstract
Mastocytosis is a hematologic neoplasm characterized by expansion and focal accumulation of neoplastic mast cells (MC) in diverse organs, including the skin, bone marrow (BM), spleen, liver, and gastrointestinal tract. The World Health Organization classification divides the disease into prognostically distinct variants of cutaneous mastocytosis (CM) and systemic mastocytosis (SM). Although this classification remains valid, recent developments in the field and the advent of new diagnostic and prognostic parameters created a need to update and refine definitions and diagnostic criteria in MC neoplasms. In addition, MC activation syndromes (MCAS) and genetic features predisposing to SM and MCAS have been identified. To discuss these developments and refinements in the classification, we organized a Working Conference comprised of experts from Europe and the United States in August 2020. This article reports on outcomes from this conference. Of particular note, we propose adjustments in the classification of CM and SM, refinements in diagnostic criteria of SM variants, including smoldering SM and BM mastocytosis (BMM), and updated criteria for MCAS and other conditions involving MC. CD30 expression in MC now qualifies as a minor SM criterion, and BMM is now defined by SM criteria, absence of skin lesions and absence of B- and C-findings. A basal serum tryptase level exceeding 20 ng/mL remains a minor SM criterion, with recognition that hereditary alpha-tryptasemia and various myeloid neoplasms may also cause elevations in tryptase. Our updated proposal will support diagnostic evaluations and prognostication in daily practice and the conduct of clinical trials in MC disorders.
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Well-differentiated SM (WDSM) is not recognized as an independent subtype according to 2022 ICC and WHO 5th Edition.
“Well-differentiated SM (WDSM) is a variant of systemic mastocytosis not recognized as an independent subtype according to 2022 ICC and WHO 5th Edition.”
From Defining “Normal” basal serum tryptase levels: a context-dependent approach to improve diagnostics in systemic mastocytosis (2025) · cites this paper as [10]
The ‘Impact of WD MC morphology’ section says well-differentiated morphology can occur across forms of systemic mastocytosis and should be appended to the diagnosis and WHO variant, rather than treated as an independent subtype. But this 2021 consensus proposal does not establish what the 2022 ICC or WHO 5th Edition classifications recognize. (LLM, conf=0.88)
Experimental — accuracy not yet measuredA recent proposal suggested normalizing BST value by dividing it by the number of extra copies of the TPSAB1 gene plus one.
“A recent proposal (10), also received by the 5th WHO classification (8), suggested normalizing BST value by dividing it by the number of extra copies of the TPSAB1 gene, encoding alpha tryptase, plus one.”
From Defining “Normal” basal serum tryptase levels: a context-dependent approach to improve diagnostics in systemic mastocytosis (2025) · cites this paper as [10]
If another hematological neoplasm is present, the baseline serum tryptase ≥ 20 ng/mL minor criterion for systemic mastocytosis is no longer valid, and in the case of HαT, the tryptase level should be adjusted.
“Importantly, if another hematological neoplasm is present, this criterion is no longer valid, and in the case of HαT, the tryptase level should be adjusted [56].”
From Diagnostic Significance of Tryptase for Suspected Mast Cell Disorders (2023) · cites this paper as [56]
Tryptase is correlated with disease severity since tryptase serves as a B-finding if it is above 200 ng/mL (adjusted for TPSAB1 status).
“It is however correlated with disease severity since tryptase serves a B-finding if it is above 200 ng/mL (adjusted for the TPSAB1 status) [56,72].”
From Diagnostic Significance of Tryptase for Suspected Mast Cell Disorders (2023) · cites this paper as [56]
Mastocytosis was diagnosed using current World Health Organization criteria.
“A diagnosis of mastocytosis was obtained using current World Health Organization criteria.17,18”
From Low Prevalence of Idiopathic Mast Cell Activation Syndrome Among 703 Patients With Suspected Mast Cell Disorders (2024) · cites this paper as [18]
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Self-citationRecent Advances in Mastocytosis Research
Valent, P., Escribano, L., Parwaresch, R. M., Schemmel, V., Schwartz, L. B., Sotlar, K., Sperr, W. R., & Horny, H. (1999) · International Archives of Allergy and Immunology · doi:10.1159/000024214 · Cited by 71 · see citing works
Self-citationFrequency and prognostic impact of KIT and other genetic variants in indolent systemic mastocytosis
Muñoz‐González, J. I., Álvarez‐Twöse, I., Jara‐Acevedo, M., Henriques, A., Viñas, E., Prieto, C., Sánchez‐Muñoz, L., Caldas, C., Mayado, A., Matito, A., et al. (2019) · Blood · doi:10.1182/blood.2018886507 · Cited by 71 · see citing works
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Self-citationOmalizumab therapy for mast cell-mediator symptoms in patients with ISM, CM, MMAS, and MCAS
Lemal, R., Fouquet, G., Terriou, L., Vaes, M., Livideanu, C. B., Frenzel, L., Barete, S., Canioni, D., Lhermitte, L., Rossignol, J., et al. (2019) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2019.03.039 · Cited by 70 · see citing works
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Self-citationEpidemiology, Diagnosis, and Treatment of Hymenoptera Venom Allergy in Mastocytosis Patients
Niedoszytko, M., Bonadonna, P., Elberink, J. N. G. O., & Golden, D. B. K. (2014) · Immunology and Allergy Clinics of North America · doi:10.1016/j.iac.2014.02.004 · Cited by 67 · see citing works
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Self-citationIncidence and prognostic impact of cytogenetic aberrations in patients with systemic mastocytosis
Naumann, N., Jawhar, M., Schwaab, J., Kluger, S., Lübke, J., Metzgeroth, G., Popp, H. D., Khaled, N., Horny, H., Sotlar, K., et al. (2018) · Genes Chromosomes and Cancer · doi:10.1002/gcc.22526 · Cited by 66 · see citing works
Self-citationIdentification of the Ki-1 antigen (CD30) as a novel therapeutic target in systemic mastocytosis
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Self-citationMast cell sarcoma: new cases and literature review
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Self-citationMorphologic and Immunophenotypic Properties of Neoplastic Cells in a Case of Mast Cell Sarcoma
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Self-citationMast Cell Sarcoma: A Rare and Aggressive Entity—Report of Two Cases and Review of the Literature
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Self-citationSystemic mastocytosis as a risk factor for severe Hymenoptera sting–induced anaphylaxis
Álvarez‐Twöse, I., Bonadonna, P., Matito, A., Zanotti, R., González‐de‐Olano, D., Sánchez‐Muñoz, L., Morgado, J. M., Órfão, A., & Escribano, L. (2012) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2012.10.052 · Cited by 46 · see citing works
Self-citationPrevalence and risk factors for fragility fracture in systemic mastocytosis
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Self-citationCytogenetic and molecular aberrations and worse outcome for male patients in systemic mastocytosis
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Self-citationEuropean Competence Network on Mastocytosis (ECNM): 10-year jubilee, update, and future perspectives
Valent, P., Arock, M., Bonadonna, P., Brockow, K., Broesby‐Olsen, S., Escribano, L., Gleixner, K. V., Grattan, C. E. H., Hadzijusufovic, E., Hägglund, H., et al. (2012) · Wiener klinische Wochenschrift · doi:10.1007/s00508-012-0293-z · Cited by 37 · see citing works
Self-citationClinical Impact of Inherited and Acquired Genetic Variants in Mastocytosis
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Self-citationSolitary mast cell "tumor" of lung. Its place in the spectrum of mast cell disease
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Self-citationSolitary mast cell tumor of the lung
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Myelomastocytic leukemia: histopathological features, diagnostic criteria and differential diagnosis
Horny, H., Sotlar, K., Reiter, A., & Valent, P. (2014) · Expert Review of Hematology · doi:10.1586/17474086.2014.942280 · Cited by 30 · see citing works
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Self-citationComplete response to gemtuzumab ozogamicin in a patient with refractory mast cell leukemia
Álvarez‐Twöse, I., Martinez‐Barranco, P., Gotlib, J. R., García‐Montero, A. C., Morgado, J. M., Jara‐Acevedo, M., Merker, J. D., Peñalver, F. J., Matito, A., Hou, Y., et al. (2016) · Leukemia · doi:10.1038/leu.2016.30 · Cited by 24 · see citing works
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Allogeneic Hematopoietic Stem Cell Transplantation in a Rare Case of Tonsillar Mast Cell Sarcoma
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Self-citation
Flagged first, then by citations
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Khoury, J. D., Solary, E., Abla, O., Akkari, Y., Alaggio, R., Apperley, J. F., Bejar, R., Berti, E., Busque, L., Chan, J. K. C., et al. (2022) · Leukemia · doi:10.1038/s41375-022-01613-1 · Cited by 4,274 · see citing works
Arber, D. A., Orazi, A., Hasserjian, R. P., Borowitz, M. J., Calvo, K. R., Kvasnicka, H.-M., Wang, S. A., Bagg, A., Barbui, T., Branford, S., et al. (2022) · Blood · doi:10.1182/blood.2022015850 · Cited by 2,945 · see citing works
Self-citationSystemic mastocytosis in adults: 2023 update on diagnosis, risk stratification and management
Pardanani, A. (2023) · American Journal of Hematology · doi:10.1002/ajh.26962 · Cited by 132 · see citing works
Valent, P., Hartmann, K., Bonadonna, P., Gülen, T., Brockow, K., Alvarez-Twose, I., Hermine, O., Niedoszytko, M., Carter, M. C., Hoermann, G., et al. (2022) · The Journal of Allergy and Clinical Immunology: In Practice · doi:10.1016/j.jaip.2022.05.007 · Cited by 90 · see citing works
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Self-citationClinical relevance of inherited genetic differences in human tryptases
Glover, S. C., Carter, M. C., Korošec, P., Bonadonna, P., Schwartz, L. B., Milner, J. D., Caughey, G. H., Metcalfe, D. D., & Lyons, J. J. (2021) · Annals of Allergy, Asthma & Immunology · doi:10.1016/j.anai.2021.08.009 · Cited by 64 · see citing works
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Kačar, M., Rijavec, M., Šelb, J., & Korošec, P. (2023) · Clinical & Experimental Allergy · doi:10.1111/cea.14264 · Cited by 37 · see citing works
Review and updates on systemic mastocytosis and related entities
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Disease Spectrum of Anaphylaxis Disorders
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- Authors
- Valent, P., Akin, C., Hartmann, K., Alvarez-Twose, I., Brockow, K., Hermine, O., Niedoszytko, M., Schwaab, J., Lyons, J. J., Carter, M. C., Elberink, H. O., Butterfield, J. H., George, T. I., Greiner, G., Ustun, C., Bonadonna, P., Sotlar, K., Nilsson, G., Jawhar, M., Siebenhaar, F., Broesby-Olsen, S., Yavuz, S., Zanotti, R., Lange, M., Nedoszytko, B., Hoermann, G., Castells, M., Radia, D. H., Muñoz-Gonzalez, J. I., Sperr, W. R., Triggiani, M., Kluin-Nelemans, H. C., Galli, S. J., Schwartz, L. B., Reiter, A., Orfao, A., Gotlib, J., Arock, M., Horny, H.-P., & Metcalfe, D. D.
- Affiliations
- Ludwig Boltzmann Institute for Hematology and Oncology (AT)
- University of Michigan (US)
- University of Basel (CH)
- Instituto de Estudios de Mastocitosis de Castilla La Mancha (CLMast) and CIBERONC, Hospital Virgen del Valle, Toledo, Spain
- Technical University of Munich (DE)
- Hôpital Necker-Enfants Malades (FR)
- Gdańsk Medical University (PL)
- University Medical Centre Mannheim (DE)
- National Institutes of Health (US)
- University Medical Center Groningen (NL)
- Mayo Clinic (US)
- Hospital Virgen del Valle (ES)
- Division of Hematology, Oncology and Cell Therapy, Department of Medicine, The Coleman Foundation Blood and Marrow Transplant Center at Rush University Medical Center, Chicago, Illinois, USA
- Azienda Ospedaliera Universitaria Integrata Verona (IT)
- Paracelsus Medical University (AT)
- Karolinska University Hospital (SE)
- Humboldt-Universität zu Berlin (DE)
- Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark
- Department of Dermatology, Venereology and Allergology, Medical University of Gdansk, Poland
- Munich Leukemia Laboratory (Germany) (DE)
- Brigham and Women's Hospital (US)
- Guy's and St Thomas' NHS Foundation Trust (GB)
- Servicio Central de Citometria, Centro de Investigacion del Cancer (IBMCC; CSIC/USAL) Instituto Biosanitario de Salamanca (IBSAL) and Department of Medicine, University of Salamanca, Spain
- University of Salerno (IT)
- Department of Haematology, University Medical Center Groningen, University of Groningen, The Netherlands
- Stanford Medicine (US)
- Virginia Commonwealth University (US)
- Corresponding author
- Valent, Peter
- ORCID
- Valent, Peter
- Akin, Cem
- Hartmann, Karin
- Brockow, Knut
- Hermine, Olivier
- Niedoszytko, Marek
- Schwaab, Juliana
- Lyons, Jonathan J.
- Carter, Melody C.
- Elberink, Hanneke Oude
- Butterfield, Joseph H.
- George, Tracy I.
- Greiner, Georg
- Bonadonna, Patrizia
- Sotlar, Karl
- Nilsson, Gunnar
- Jawhar, Mohamad
- Siebenhaar, Frank
- Yavuz, Selim
- Zanotti, Roberta
- Lange, Magdalena
- Hoermann, Gregor
- Castells, Mariana
- Radia, Deepti H.
- Sperr, Wolfgang R.
- Triggiani, Massimo
- Galli, Stephen J.
- Schwartz, Lawrence B.
- Reiter, Andreas
- Gotlib, Jason
- Arock, Michel
- Metcalfe, Dean D.
- Venue
- HemaSphere
- Publisher
- Wiley
- Published
- 2021-10-13
- Volume
- 5
- Issue
- 11
- Pages
- e646
- ISSN
- 2572-9241 (ISSN-L)
- PMC
- PMC8659997
- OpenAlex
- W3206166311
- Cited by
- 317
- References
- 107
- Citations by year
- 2026: 42 · 2025: 75 · 2024: 71 · 2023: 79 · 2022: 48 · 2021: 1
- FWCI
- 5.10
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- HemaSphere (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, cc-by-nc-nd)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- edoc (University of Basel) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion, other-oa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by-nc-nd)
- Funders
- Austrian Science Fund (P32470‐B, #F4704-B20, P 32470)
- Cancerfonden
- Vetenskapsrådet
- National Institute of Allergy and Infectious Diseases
- NHLBI Division of Intramural Research
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Mast cells and histamine
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal Tumor Research and Treatment
- Health Sciences › Medicine › Physiology › Histiocytic Disorders and Treatments
- Keywords
- mastocytosis, mast cell disease, diagnostic criteria, classification, cutaneous mastocytosis, systemic mastocytosis, mast cell activation syndrome, bone marrow mastocytosis, CD30 expression, serum tryptase, hereditary alpha-tryptasemia, prognostic criteria
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