{"entity":{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","aka":[],"tldr":"Bone-marrow disorders where blood cells are made badly and too few reach the blood; a third progress to acute leukaemia. Treatment ranges from transfusions and growth factors to hypomethylating drugs and, for the fit, transplant.","summary":"MDS are clonal myeloid neoplasms with ineffective haematopoiesis, cytopenias, dysplasia and variable risk of transformation to AML. Risk is stratified by IPSS-R and, since 2022, the molecular IPSS-M, which incorporates mutations (TP53 multi-hit, ASXL1, RUNX1, SF3B1 among 31 genes). The WHO 2022 and ICC classifications define genetically specified entities (SF3B1-mutant, del(5q), biallelic TP53) and renamed the group 'myelodysplastic neoplasms'.\n\nLower-risk disease is treated for anaemia: erythropoiesis-stimulating agents, lenalidomide for del(5q), luspatercept (MEDALIST 2020, COMMANDS 2023 first line), and imetelstat (IMerge, 2024) after ESA failure. Higher-risk disease is treated with hypomethylating agents (azacitidine, decitabine, oral decitabine-cedazuridine) and, for the fit with a donor, allogeneic transplant, the only cure. Three large phase 3 additions to azacitidine failed in 2023-24 (magrolimab ENHANCE, sabatolimab STIMULUS-MDS2, venetoclax VERONA), leaving azacitidine alone as the higher-risk standard.\n\nOpen problems: TP53-mutant MDS, post-HMA failure (median survival under six months), and how to use IPSS-M to time transplant.","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Myelodysplastic_syndrome","links":[{"label":"IPSS-M (NEJM Evidence 2022)","url":"https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200008"},{"label":"NCI PDQ: MDS","url":"https://www.cancer.gov/types/myeloproliferative/patient/myelodysplastic-treatment-pdq"}],"tags":["gap-fill","haematologic"],"related":["systemic-mastocytosis"],"cancers":[],"sections":[],"technologies":["epigenetic-drugs","allogeneic-hsct","ngs-mrd-clonoseq","flow-cytometry-mrd","cytogenetics-fish","transfusion-support"],"targets":["tp53","cd47","tim3","bcl2"],"drugs":["azacitidine","decitabine-cedazuridine","lenalidomide","luspatercept","imetelstat","venetoclax","magrolimab","decitabine","dorocubicel"],"companies":["bms","gilead","novartis","taiho"],"institutions":[],"pathways":["p53-cell-cycle","apoptosis-bcl2"],"terms":["eln-risk","mrd","differentiation-syndrome"],"trials":["nct05883956","nct04256317","nct04064060"],"people":["uwe-platzbecker","pierre-fenaux"],"bottlenecks":[],"keyPapers":[],"journals":["leukemia-research"],"dependsOn":[],"notes":[],"group":"haematologic","burden":"MDS affects around 4-5 per 100,000 people per year overall, rising steeply with age (median age ~70), according to SEER.","subtypes":["MDS with low blasts (MDS-LB)","MDS with SF3B1 mutation (ring sideroblasts)","MDS with del(5q)","MDS with biallelic TP53 inactivation","MDS with increased blasts (IB1, IB2)","Hypoplastic MDS","Therapy-related MDS"],"biomarkers":["IPSS-R and IPSS-M risk","Cytogenetics (del(5q), -7, complex karyotype)","NGS panel (SF3B1, TP53, ASXL1, RUNX1, TET2, DNMT3A, SRSF2, U2AF1)","Blast percentage","Serum EPO level (ESA response prediction)","Transfusion burden"],"standardOfCare":[{"setting":"Lower risk, anaemia","approach":"ESA if serum EPO <500; luspatercept first line (COMMANDS) or after ESA failure (MEDALIST); imetelstat after ESA failure (IMerge); lenalidomide for del(5q).","refs":["luspatercept","imetelstat","lenalidomide"],"guideline":{"nccn":"Category 1 (luspatercept), Category 2A (imetelstat)","version":"NCCN Guidelines: MDS","url":"https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1446"}},{"setting":"Higher risk, transplant candidate","approach":"Allogeneic HSCT, usually after hypomethylating-agent cytoreduction; BMT CTN 1102 showed a survival benefit for transplant in 50-75-year-olds.","refs":["allogeneic-hsct","azacitidine","bmt-ctn-1102"],"guideline":{"version":"NCCN Guidelines: MDS","url":"https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1446"}},{"setting":"Higher risk, not transplant candidate","approach":"Azacitidine (AZA-001) or decitabine / oral decitabine-cedazuridine until progression; supportive care and trials.","refs":["azacitidine","decitabine-cedazuridine"],"guideline":{"nccn":"Category 1 (azacitidine)","version":"NCCN Guidelines: MDS"}},{"setting":"Supportive care, all risks","approach":"Transfusion, iron chelation for transfusional iron overload (TELESTO), infection management, G-CSF for neutropenic infection.","refs":["transfusion-support","g-csf-growth-factors","telesto"]}],"stateOfArt":["IPSS-M (2022) reclassifies about half of patients relative to IPSS-R and is now the recommended risk model.","Two new drugs for lower-risk anaemia in four years: luspatercept and imetelstat, both reducing transfusion dependence.","Higher-risk MDS has had no new drug since azacitidine: the 2023-24 failures of magrolimab, sabatolimab and venetoclax combinations were a field-wide setback.","Allogeneic transplant remains the only cure; reduced-intensity conditioning extends it to older patients."],"history":[{"year":1982,"title":"FAB classification of MDS","note":"Bennett and colleagues define refractory anaemia, RARS, RAEB, RAEB-T and CMML.","refs":[]},{"year":1997,"title":"IPSS risk score","note":"Greenberg's International Prognostic Scoring System combines blasts, cytogenetics and cytopenias.","refs":[]},{"year":2004,"title":"Azacitidine approved","note":"First drug approved for MDS (US); AZA-001 (2009) shows survival benefit in higher-risk disease.","refs":["azacitidine"]},{"year":2005,"title":"Lenalidomide for del(5q)","note":"Transfusion independence in two-thirds of del(5q) patients (List et al.).","refs":["lenalidomide"]},{"year":2012,"title":"IPSS-R","note":"Revised score with five cytogenetic groups and refined thresholds.","refs":[]},{"year":2020,"title":"Luspatercept approved","note":"MEDALIST in ring-sideroblast MDS after ESA failure; COMMANDS (2023) moves it to first line.","refs":["luspatercept"]},{"year":2022,"title":"IPSS-M and WHO5/ICC","note":"Molecular risk model with 31 genes; classification renamed myelodysplastic neoplasms with genetically defined entities.","refs":[]},{"year":2023,"title":"Higher-risk combinations fail","note":"Magrolimab (ENHANCE) and sabatolimab (STIMULUS-MDS2) add nothing to azacitidine; VERONA (venetoclax) negative in 2024.","refs":["magrolimab","venetoclax","azacitidine"]},{"year":2024,"title":"Imetelstat approved","note":"IMerge: telomerase inhibitor achieves durable transfusion independence after ESA failure.","refs":["imetelstat"]}],"pipeline":["imetelstat","luspatercept","allogeneic-hsct","tuspetinib","bexmarilimab","spartalizumab","sabatolimab","ard103"],"openProblems":["No drug has beaten azacitidine in higher-risk MDS.","TP53-mutant and complex-karyotype disease: median survival about a year even after transplant.","Clonal cytopenia of undetermined significance (CCUS): who to watch, who to treat.","Post-HMA failure has no standard."]},"route":"/cancers/mds/","neighbours":{"cancer":[{"id":"cmml","kind":"cancer","name":"Chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms","route":"/cancers/cmml/"},{"id":"mds-higher-risk","kind":"cancer","name":"Higher-risk myelodysplastic syndromes","route":"/cancers/mds-higher-risk/"},{"id":"mds-lower-risk","kind":"cancer","name":"Lower-risk myelodysplastic syndromes","route":"/cancers/mds-lower-risk/"},{"id":"systemic-mastocytosis","kind":"cancer","name":"Systemic mastocytosis","route":"/cancers/systemic-mastocytosis/"}],"technology":[{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"},{"id":"cd47-blockade","kind":"technology","name":"CD47 and SIRP-alpha blockade","route":"/technologies/cd47-blockade/"},{"id":"cytogenetics-fish","kind":"technology","name":"Cytogenetics and FISH","route":"/technologies/cytogenetics-fish/"},{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"},{"id":"functional-precision-medicine-haematology","kind":"technology","name":"Ex vivo drug sensitivity screening in blood cancers (EXALT)","route":"/technologies/functional-precision-medicine-haematology/"},{"id":"g-csf-growth-factors","kind":"technology","name":"Growth factors: G-CSF and febrile neutropenia prevention","route":"/technologies/g-csf-growth-factors/"},{"id":"flow-cytometry-mrd","kind":"technology","name":"Multiparameter flow cytometry MRD","route":"/technologies/flow-cytometry-mrd/"},{"id":"ngs-mrd-clonoseq","kind":"technology","name":"NGS-based MRD (clonoSEQ and molecular MRD)","route":"/technologies/ngs-mrd-clonoseq/"},{"id":"tim3-blockade","kind":"technology","name":"TIM-3 blockade","route":"/technologies/tim3-blockade/"},{"id":"transfusion-support","kind":"technology","name":"Transfusion support and anaemia management","route":"/technologies/transfusion-support/"}],"target":[{"id":"asxl1","kind":"target","name":"ASXL1","route":"/targets/asxl1/"},{"id":"bcl2","kind":"target","name":"BCL-2","route":"/targets/bcl2/"},{"id":"bcor","kind":"target","name":"BCOR","route":"/targets/bcor/"},{"id":"cd47","kind":"target","name":"CD47","route":"/targets/cd47/"},{"id":"cda","kind":"target","name":"CDA","route":"/targets/cda/"},{"id":"cereblon","kind":"target","name":"Cereblon (CRBN)","route":"/targets/cereblon/"},{"id":"cul4a","kind":"target","name":"CUL4A","route":"/targets/cul4a/"},{"id":"ddb1","kind":"target","name":"DDB1","route":"/targets/ddb1/"},{"id":"ddx41","kind":"target","name":"DDX41","route":"/targets/ddx41/"},{"id":"dnmt3a","kind":"target","name":"DNA methyltransferase 3A (DNMT3A)","route":"/targets/dnmt3a/"},{"id":"dnmt1","kind":"target","name":"DNMT1 (DNA methyltransferase 1)","route":"/targets/dnmt1/"},{"id":"etv6","kind":"target","name":"ETV6","route":"/targets/etv6/"},{"id":"fancc","kind":"target","name":"FANCC","route":"/targets/fancc/"},{"id":"gata2","kind":"target","name":"GATA2","route":"/targets/gata2/"},{"id":"kir2dl1","kind":"target","name":"KIR2DL1 (inhibitory KIR)","route":"/targets/kir2dl1/"},{"id":"mpl","kind":"target","name":"MPL (thrombopoietin receptor)","route":"/targets/mpl/"},{"id":"mt-co1","kind":"target","name":"MT-CO1","route":"/targets/mt-co1/"},{"id":"mysm1","kind":"target","name":"MYSM1","route":"/targets/mysm1/"},{"id":"pola2","kind":"target","name":"POLA2","route":"/targets/pola2/"},{"id":"pold2","kind":"target","name":"POLD2","route":"/targets/pold2/"},{"id":"pold3","kind":"target","name":"POLD3","route":"/targets/pold3/"},{"id":"pold4","kind":"target","name":"POLD4","route":"/targets/pold4/"},{"id":"pole2","kind":"target","name":"POLE2","route":"/targets/pole2/"},{"id":"pole3","kind":"target","name":"POLE3","route":"/targets/pole3/"},{"id":"prim1","kind":"target","name":"PRIM1","route":"/targets/prim1/"},{"id":"prim2","kind":"target","name":"PRIM2","route":"/targets/prim2/"},{"id":"rbx1","kind":"target","name":"RBX1","route":"/targets/rbx1/"},{"id":"rrm2","kind":"target","name":"RRM2","route":"/targets/rrm2/"},{"id":"rrm2b","kind":"target","name":"RRM2B","route":"/targets/rrm2b/"},{"id":"runx1","kind":"target","name":"RUNX1","route":"/targets/runx1/"},{"id":"samd9","kind":"target","name":"SAMD9","route":"/targets/samd9/"},{"id":"samd9l","kind":"target","name":"SAMD9L","route":"/targets/samd9l/"},{"id":"setbp1","kind":"target","name":"SETBP1","route":"/targets/setbp1/"},{"id":"sf3b1","kind":"target","name":"SF3B1","route":"/targets/sf3b1/"},{"id":"sh2b3","kind":"target","name":"SH2B3","route":"/targets/sh2b3/"},{"id":"slx4","kind":"target","name":"SLX4","route":"/targets/slx4/"},{"id":"srsf2","kind":"target","name":"SRSF2","route":"/targets/srsf2/"},{"id":"tgfb1","kind":"target","name":"TGFB1","route":"/targets/tgfb1/"},{"id":"tgfb2","kind":"target","name":"TGFB2","route":"/targets/tgfb2/"},{"id":"tgfb3","kind":"target","name":"TGFB3","route":"/targets/tgfb3/"},{"id":"tim3","kind":"target","name":"TIM-3","route":"/targets/tim3/"},{"id":"tp53","kind":"target","name":"TP53","route":"/targets/tp53/"},{"id":"u2af1","kind":"target","name":"U2AF1","route":"/targets/u2af1/"}],"drug":[{"id":"tregzi","kind":"drug","name":"Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq","route":"/drugs/tregzi/"},{"id":"ard103","kind":"drug","name":"ARD103","route":"/drugs/ard103/"},{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"belumosudil","kind":"drug","name":"Belumosudil","route":"/drugs/belumosudil/"},{"id":"bexmarilimab","kind":"drug","name":"Bexmarilimab","route":"/drugs/bexmarilimab/"},{"id":"decitabine","kind":"drug","name":"Decitabine","route":"/drugs/decitabine/"},{"id":"decitabine-cedazuridine","kind":"drug","name":"Decitabine + cedazuridine (oral)","route":"/drugs/decitabine-cedazuridine/"},{"id":"dorocubicel","kind":"drug","name":"Dorocubicel (UM171-expanded cord blood)","route":"/drugs/dorocubicel/"},{"id":"elritercept","kind":"drug","name":"Elritercept","route":"/drugs/elritercept/"},{"id":"eltrombopag","kind":"drug","name":"Eltrombopag","route":"/drugs/eltrombopag/"},{"id":"imetelstat","kind":"drug","name":"Imetelstat","route":"/drugs/imetelstat/"},{"id":"lenalidomide","kind":"drug","name":"Lenalidomide","route":"/drugs/lenalidomide/"},{"id":"luspatercept","kind":"drug","name":"Luspatercept","route":"/drugs/luspatercept/"},{"id":"magrolimab","kind":"drug","name":"Magrolimab","route":"/drugs/magrolimab/"},{"id":"omidubicel","kind":"drug","name":"Omidubicel","route":"/drugs/omidubicel/"},{"id":"ravulizumab","kind":"drug","name":"Ravulizumab","route":"/drugs/ravulizumab/"},{"id":"romiplostim","kind":"drug","name":"Romiplostim","route":"/drugs/romiplostim/"},{"id":"sabatolimab","kind":"drug","name":"Sabatolimab","route":"/drugs/sabatolimab/"},{"id":"spartalizumab","kind":"drug","name":"Spartalizumab","route":"/drugs/spartalizumab/"},{"id":"treosulfan","kind":"drug","name":"Treosulfan","route":"/drugs/treosulfan/"},{"id":"tuspetinib","kind":"drug","name":"Tuspetinib","route":"/drugs/tuspetinib/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"company":[{"id":"aprea-therapeutics","kind":"company","name":"Aprea 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signal)","route":"/pathways/cd47-sirpa/"},{"id":"apoptosis-bcl2","kind":"pathway","name":"Intrinsic apoptosis (BCL-2 family)","route":"/pathways/apoptosis-bcl2/"},{"id":"idh-2hg","kind":"pathway","name":"Mutant IDH / 2-hydroxyglutarate","route":"/pathways/idh-2hg/"},{"id":"p53-cell-cycle","kind":"pathway","name":"p53 / RB / cell-cycle checkpoint","route":"/pathways/p53-cell-cycle/"},{"id":"p53-mdm2-axis","kind":"pathway","name":"The p53 network (guardian of the genome)","route":"/pathways/p53-mdm2-axis/"}],"term":[{"id":"ageing-tissue-field-theory","kind":"term","name":"Ageing tissue and clonal fields: cancer as a disease of old tissue","route":"/terms/ageing-tissue-field-theory/"},{"id":"rejuv-second-alkylating-agents-and-myeloid-neoplasms","kind":"term","name":"Alkylating agents and therapy-related myeloid 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(azacitidine, decitabine)","route":"/terms/hma/"},{"id":"imid","kind":"term","name":"Immunomodulatory drugs (IMiDs) and CELMoDs","route":"/terms/imid/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"rejuv-second-platinum-and-parp-inhibitors","kind":"term","name":"Platinum drugs and PARP inhibitors: the newer leukaemia risk","route":"/terms/rejuv-second-platinum-and-parp-inhibitors/"},{"id":"secondary-malignancy","kind":"term","name":"Secondary malignancy (therapy-related cancer)","route":"/terms/secondary-malignancy/"},{"id":"rejuv-second-topoisomerase-inhibitors-short-latency","kind":"term","name":"Topoisomerase II inhibitors and the shorter latency","route":"/terms/rejuv-second-topoisomerase-inhibitors-short-latency/"}],"trial":[{"id":"nct05589896","kind":"trial","name":"A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies","route":"/trials/nct05589896/"},{"id":"nct04256317","kind":"trial","name":"A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)","route":"/trials/nct04256317/"},{"id":"nct05883956","kind":"trial","name":"A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia","route":"/trials/nct05883956/"},{"id":"nct04771130","kind":"trial","name":"A Study of BGB-11417 in Participants With Myeloid Malignancies","route":"/trials/nct04771130/"},{"id":"nct05732103","kind":"trial","name":"A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes","route":"/trials/nct05732103/"},{"id":"nct06499285","kind":"trial","name":"A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk 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