{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T05:02:58Z","timestamp":1789448578183,"version":"build-2803163510"},"reference-count":57,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T00:00:00Z","timestamp":1789430400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Antineoplastic drugs are effective for malignant tumours, but they frequently cause severe adverse drug reactions (ADRs), which seriously affect treatment continuity and patient prognosis. Post - marketing real - world safety monitoring is therefore critical.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a retrospective pharmacovigilance study using FAERS (FDA Adverse Event Reporting System) data covering the period from 2004 Q1 to 2025 Q4. Safety signals were detected via disproportionate analysis, and associations were identified through LASSO and multivariable logistic regression, followed by an analysis of time to onset (TTO) for haematotoxicity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 347, 248 reports involving 367 antitumour drugs were analysed. Female patients (46.51%) outnumbered males (38.73%), with a median age of 59 years; patients aged 18 - 64.9 years represented 34.79% of the cohort. Fatal or life - threatening events were recorded in 78, 824 cases (22.70%). The leading drugs by report frequency were lenalidomide (ROR (Reporting Odds Ratio) = 1.51), methotrexate (ROR\u00a0=\u00a02.98), and rituximab (ROR\u00a0=\u00a03.69). Most events (61.65%) emerged within the first month, and median TTO differ significantly by sex. Furthermore, WSP analysis revealed that 26 of the top 30 drugs followed an early failure pattern.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our findings reveal a strong signal of haematological toxicity associated with antitumour agents, supporting enhanced routine monitoring to mitigate clinical risks. Nevertheless, confirmation through pharmacoepidemiological studies with rigorous causality assessment is required, owing to the inherent limitations of the FAERS spontaneous reporting system.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2026.1947521","type":"journal-article","created":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T04:26:58Z","timestamp":1789446418000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Haematological toxicity associated with antineoplastic drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database"],"prefix":"10.3389","volume":"17","author":[{"given":"Xingnong","family":"Xu","sequence":"first","affiliation":[{"name":"School of Pharmacy, East China University of Science and Technology","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Ma","sequence":"additional","affiliation":[{"name":"School of Pharmacy, East China University of Science and Technology","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,15]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"793","DOI":"10.3760\/cma.j.cn112137-20241029-02425","article-title":"Expert consensus on out-of-hospital management of myelosuppression related to tumor treatment (2025 edition)","volume":"105","year":"2025","journal-title":"Chin Med J"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-030-20315-3_9","article-title":"Management of thrombocytopenia in cancer patients","volume":"179","author":"Mones","year":"2019","journal-title":"Cancer Treat Res"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.3389\/fgene.2025.1704489","article-title":"The risk factors for chemotherapy myelosuppression in breast cancer: a systematic review and meta-analysis","volume":"16","author":"Zhu","year":"2025","journal-title":"Front Genet"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v31.i42.112180","article-title":"Predicting chemotherapy-induced myelosuppression in colorectal cancer: an interpretable, machine learning-based nomogram","volume":"31","author":"Liu","year":"2025","journal-title":"World J Gastroenterol"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2025.12.033","article-title":"Skull dosimetry for mitigating acute hematologic toxicity in patients with non-small cell lung cancer with brain metastases undergoing cranial radiation therapy and immunotherapy","volume":"125","author":"Ma","year":"2026","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-020-01419-6","article-title":"Patient burden and real-world management of chemotherapy-induced myelosuppression: results from an online survey of patients with solid tumors","volume":"37","author":"Epstein","year":"2020","journal-title":"Adv Ther"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.3389\/fvets.2025.1635504","article-title":"Efficacy of formula against canine lymphoma chemotherapy-induced myelosuppression","volume":"12","author":"Pan","year":"2025","journal-title":"Front Vet Sci"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.26508\/lsa.202302244","article-title":"Enhancer mutations modulate the severity of chemotherapy-induced myelosuppression","volume":"7","author":"Zhigulev","year":"2024","journal-title":"Life Sci Alliance"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.14744\/ejmo.2019.94710","article-title":"Ethnic differences in hematologic toxicity from imatinib in patients with gastrointestinal stromal cell tumor (GIST): coincidence or a real phenomenon","volume":"3","author":"Saif","year":"2019","journal-title":"Eurasian J Med Oncol"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2025.1585048","article-title":"Nimotuzumab plus chemotherapy and immunotherapy as first-line\/neoadjuvant therapy for advanced esophageal squamous cell carcinoma","volume":"16","author":"Wang","year":"2025","journal-title":"Front Pharmacol"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-15-0775","article-title":"Preclinical characterization of G1T28: a novel CDK4\/6 inhibitor for reduction of chemotherapy-induced myelosuppression","volume":"15","author":"Bisi","year":"2016","journal-title":"Mol Cancer Ther"},{"key":"B12","doi-asserted-by":"publisher","first-page":"17464","DOI":"10.1038\/s41598-023-42725-7","article-title":"A nomogram for predicting severe myelosuppression in small cell lung cancer patients following the first-line chemotherapy","volume":"13","author":"Li","year":"2023","journal-title":"Sci Rep"},{"key":"B13","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1007\/s00280-024-04640-0","article-title":"Impact of bariatric surgery on oral anticancer drugs: an analysis of real-world data","volume":"94","author":"Lau","year":"2024","journal-title":"Cancer Chemother Pharmacol"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1111\/joim.13703","article-title":"Thrombotic microangiopathy associated with anticancer and immune system targeting drugs: new insights from real-world data using the WHO pharmacovigilance database","volume":"294","author":"Largeau","year":"2023","journal-title":"J Intern Med"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0000000000001036","article-title":"Pharmacodynamic model-based safety management of eribulin-induced myelosuppression in patients with breast cancer","volume":"45","author":"Kasai","year":"2023","journal-title":"Ther Drug Monit"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2025.1524159","article-title":"Real-world pharmacovigilance investigation of imipenem\/cilastatin: signal detection using the FDA Adverse Event Reporting System (FAERS) database","volume":"16","author":"Jia","year":"2025","journal-title":"Front Pharmacol"},{"key":"B17","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1186\/s40360-025-00959-3","article-title":"A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database","volume":"26","author":"Huang","year":"2025","journal-title":"BMC Pharmacol Toxicol"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2025.1687088","article-title":"A real-world data analysis of piroxicam in the FDA Adverse Event Reporting System (FAERS) database","volume":"12","author":"Wang","year":"2025","journal-title":"Front Med (Lausanne)"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1397029","article-title":"A real-world data analysis of tirzepatide in the FDA adverse event reporting system (FAERS) database","volume":"15","author":"Liu","year":"2024","journal-title":"Front Pharmacol"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000044535","article-title":"A real-world data analysis of Ozanimod in the FDA Adverse Event Reporting System (FAERS) database","volume":"104","author":"Tang","year":"2025","journal-title":"Med (Baltimore)"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2025.1558868","article-title":"A real-world pharmacovigilance analysis of omadacycline in FDA adverse event reporting system (FAERS) database","volume":"16","author":"Shi","year":"2025","journal-title":"Front Pharmacol"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2025.121039","article-title":"A real-world pharmacovigilance study of modafinil events in the FDA Adverse Event Reporting System (FAERS)","volume":"398","author":"Zhang","year":"2026","journal-title":"J Affect Disord"},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2025.1665425","article-title":"Hepatotoxicity associated with anti-neoplastic agents: a pharmacovigilance analysis of the Food and Drug Administration Adverse Event Reporting System database","volume":"16","author":"Shi","year":"2025","journal-title":"Front Immunol"},{"key":"B24","doi-asserted-by":"publisher","DOI":"10.1177\/20420986251401122","article-title":"Cardiotoxicity associated with antineoplastic agents: a pharmacovigilance study based on FDA adverse event reporting system","volume":"16","author":"Qiu","year":"2025","journal-title":"Ther Adv Drug Saf"},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2023.101967","article-title":"Psychiatric disorders associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database","volume":"59","author":"Zhou","year":"2023","journal-title":"EClinicalMedicine"},{"key":"B26","doi-asserted-by":"publisher","DOI":"10.1097\/JS9.0000000000004688","article-title":"Sex-biased associations between gut microbiota and hematologic toxicity of neoadjuvant chemoradiotherapy in locally advanced rectal cancer","volume":"112","author":"Sui","year":"2026","journal-title":"Int J Surg"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1007\/s11060-022-04203-4","article-title":"Patterns, predictors and prognostic relevance of high-grade hematotoxicity after temozolomide or temozolomide-lomustine in the CeTeG\/NOA-09 trial","volume":"161","author":"Weller","year":"2023","journal-title":"J Neuro-Oncol"},{"key":"B28","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.ejca.2020.06.005","article-title":"Impact of sex and age on chemotherapy efficacy, toxicity and survival in localised oesophagogastric cancer: a pooled analysis of 3265 individual patient data from four large randomised trials (OE02, OE05, MAGIC and ST03)","volume":"137","author":"Athauda","year":"2020","journal-title":"Eur J Cancer"},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1177\/10732748251337362","article-title":"Signal mining and analysis of drug-induced myelosuppression: a real-world study from FAERS","volume":"32","author":"Xia","year":"2025","journal-title":"Cancer Control"},{"key":"B30","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1186\/s12885-025-15391-3","article-title":"Hematological toxicity of immune checkpoint inhibitors: a pharmacovigilance study","volume":"26","author":"Tan","year":"2025","journal-title":"BMC Cancer"},{"key":"B31","doi-asserted-by":"publisher","DOI":"10.1111\/crj.12358","article-title":"Monocyte nadir is a possible indicator for neutrophil nadir during lung cancer chemotherapy","volume":"11","author":"Moriyama","year":"2017","journal-title":"Clin Respir J"},{"key":"B32","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2024.2348566","article-title":"Hematological toxicity of cyclin-dependent kinase 4\/6 inhibitors in patients with breast cancer: a network meta-analysis and pharmacovigilance study","volume":"24","author":"Ding","year":"2025","journal-title":"Expert Opin Drug Saf"},{"key":"B33","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aam8060","article-title":"Preventing chemotherapy-induced myelosuppression by repurposing the FLT3 inhibitor quizartinib","volume":"9","author":"Taylor","year":"2017","journal-title":"Sci Transl Med"},{"key":"B34","doi-asserted-by":"publisher","DOI":"10.2174\/1386207326666230228120608","article-title":"Effect and mechanism of specnuezhenide on chemotherapy - induced myelosuppression","volume":"26","author":"Han","year":"2023","journal-title":"Comb Chem High Throughput Screen"},{"key":"B35","doi-asserted-by":"publisher","DOI":"10.1530\/ERC-21-0082","article-title":"Long-term hematologic toxicity of 177Lu-octreotate-capecitabine-temozolomide therapy of GEPNET","volume":"28","author":"Kesavan","year":"2021","journal-title":"Endocr Relat Cancer"},{"key":"B36","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2023.1139559","article-title":"Low-dose administration of prednisone has a good effect on the treatment of prolonged hematologic toxicity post-CD19 CAR-T cell therapy","volume":"14","author":"Wang","year":"2023","journal-title":"Front Immunol"},{"key":"B37","doi-asserted-by":"publisher","first-page":"1983","DOI":"10.2147\/DDDT.S498458","article-title":"Saikosaponin A mediates the anti-acute myeloid leukemia effect via the P-JNK signaling pathway induced by endoplasmic reticulum stress","volume":"19","author":"Sun","year":"2025","journal-title":"Drug Des Devel Ther"},{"key":"B38","doi-asserted-by":"publisher","DOI":"10.3390\/cancers14133113","article-title":"Solute carrier nucleoside transporters in hematopoiesis and hematological drug toxicities: a perspective","volume":"14","author":"Ali","year":"2022","journal-title":"Cancers (Basel)"},{"key":"B39","doi-asserted-by":"publisher","DOI":"10.1056\/EVIDoa2400326","article-title":"Intermediate-dose cytarabine as postinduction AML therapy","volume":"4","author":"Hunault","year":"2025","journal-title":"NEJM Evid"},{"key":"B40","doi-asserted-by":"publisher","DOI":"10.1016\/j.bioorg.2026.109972","article-title":"A novel triazole-dithiocarbamate hybrid synergistically enhances cytarabine efficacy and selectivity in anaplastic large cell lymphoma","volume":"178","author":"Ashour","year":"2026","journal-title":"Bioorg Chem"},{"key":"B41","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12366","article-title":"ABCC4 is a determinant of cytarabine-induced cytotoxicity and myelosuppression","volume":"9","author":"Drenberg","year":"2016","journal-title":"Clin Transl Sci"},{"key":"B42","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1016\/j.mayocpiqo.2021.11.009","article-title":"Risk for postmarket black box warnings in FDA-approved monoclonal antibodies","volume":"6","author":"Hagan","year":"2021","journal-title":"Mayo Clin Proc Innov Qual Outcomes"},{"key":"B43","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2024.1386527","article-title":"Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series","volume":"15","author":"Scavone","year":"2024","journal-title":"Front Neurol"},{"key":"B44","doi-asserted-by":"publisher","DOI":"10.1016\/j.lrr.2022.100325","article-title":"Immunotherapy in indolent non-hodgkin's lymphoma","volume":"17","author":"Amhaz","year":"2022","journal-title":"Leuk Res Rep"},{"key":"B45","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2026.1845580","article-title":"Obinutuzumab-induced acute thrombocytopenia and leukopenia in ANCA-associated glomerulonephritis: case report and literature review","volume":"17","author":"Jin","year":"2026","journal-title":"Front Immunol"},{"key":"B46","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.105307","article-title":"Incidence and comparative risk of hematological adverse events across different immune checkpoint inhibitors: a network meta-analysis of randomized controlled trials","volume":"18","author":"Vajje","year":"2026","journal-title":"Cureus"},{"key":"B47","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1007\/s10238-025-01688-x","article-title":"Haematological toxicities with immune checkpoint inhibitors in digestive system tumors: a systematic review and network meta-analysis of randomized controlled trials","volume":"25","author":"Han","year":"2025","journal-title":"Clin Exp Med"},{"key":"B48","doi-asserted-by":"publisher","DOI":"10.1002\/cam4.71948","article-title":"Current knowledge of immune checkpoint inhibitor-induced thrombocytopenia: epidemiology, mechanisms, and management","volume":"15","author":"Dai","year":"2026","journal-title":"Cancer Med"},{"key":"B49","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2026.1800904","article-title":"Fatal AA-like bone marrow failure and invasive pulmonary aspergillosis after long-term pembrolizumab in squamous NSCLC: a case report","volume":"17","author":"Wang","year":"2026","journal-title":"Front Immunol"},{"key":"B50","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2025.1596842","article-title":"Post-marketing safety concerns with Tislelizumab: a disproportionality analysis of the FDA adverse event reporting system","volume":"16","author":"Li","year":"2025","journal-title":"Front Immunol"},{"key":"B51","doi-asserted-by":"publisher","DOI":"10.1177\/11795514231203864","article-title":"Therapeutic effect of extracts on letrozole-induced polycystic ovarian syndrome and its complications in murine model","volume":"16","author":"Rani","year":"2023","journal-title":"Clin Med Insights Endocrinol Diabetes"},{"key":"B52","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics17020258","article-title":"Understanding the toxicity profile of approved ADCs","volume":"17","author":"Ballest\u00edn","year":"2025","journal-title":"Pharmaceutics"},{"key":"B53","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0334513","article-title":"Hematological toxicity of anti-tumor antibody-drug conjugates: A retrospective pharmacovigilance study using the FDA adverse event reporting system","volume":"20","author":"Rao","year":"2025","journal-title":"PloS One"},{"key":"B54","doi-asserted-by":"publisher","DOI":"10.3390\/jcm15051715","article-title":"The early safety signal of sacituzumab govitecan-related toxicity and the genotype in metastatic breast cancer: A real-world preliminary report","volume":"15","author":"Mart\u00ednez-P\u00e9rez","year":"2026","journal-title":"J Clin Med"},{"key":"B55","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2278","article-title":"Model-informed therapeutic dose optimization strategies for antibody-drug conjugates in oncology: What can we learn from US Food and Drug Administration-approved antibody-drug conjugates","volume":"110","author":"Liao","year":"2021","journal-title":"Clin Pharmacol Ther"},{"key":"B56","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/15389588.2026.2645211","article-title":"Drug-associated road traffic accidents: Insights from an analysis of the FDA adverse event reporting system (FAERS) database","volume":"12","author":"Ma","year":"2026","journal-title":"Traffic Inj Prev"},{"key":"B57","doi-asserted-by":"publisher","DOI":"10.1007\/s00210-026-05363-0","article-title":"Pharmacovigilance insights into drug-induced hypercalcemia: Evidence from the U.S. FDA adverse event reporting system (FAERS) database","volume":"35","author":"Liu","year":"2026","journal-title":"Naunyn Schmiedebergs Arch Pharmacol"}],"container-title":["Frontiers in Immunology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2026.1947521\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T04:27:01Z","timestamp":1789446421000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2026.1947521\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,15]]},"references-count":57,"alternative-id":["10.3389\/fimmu.2026.1947521"],"URL":"https:\/\/doi.org\/10.3389\/fimmu.2026.1947521","relation":{},"ISSN":["1664-3224"],"issn-type":[{"value":"1664-3224","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,15]]},"article-number":"1947521"}}