Efficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data

dc.authoridCEKDEMIR, DEMET/0000-0002-1881-5166
dc.authoriddurusoy, salih sertac/0000-0002-3577-6330
dc.authoridTanrikulu, Funda/0000-0003-1878-1872
dc.contributor.authorTombak, Anil
dc.contributor.authorTanrikulu, Funda Pepedil
dc.contributor.authorDurusoy, Salih Sertac
dc.contributor.authorDincyurek, Huseyin Derya
dc.contributor.authorKaya, Emin
dc.contributor.authorUmit, Elif Gulsum
dc.contributor.authorYavasoglu, Irfan
dc.date.accessioned2024-10-26T18:00:28Z
dc.date.available2024-10-26T18:00:28Z
dc.date.issued2021
dc.departmentSivas Cumhuriyet Üniversitesi
dc.description.abstractObjective: This study aimed to retrospectively evaluate the efficacy, safety, and survival outcome of single-agent ibrutinib therapy in chronic lymphocytic leukemia patients. Materials and Methods: A total of 136 patients (mean age +/- standard deviation: 64.6 +/- 10.3 years, 66.9% males) who had received at least one dose of ibrutinib were included in this retrospective multicenter, noninterventional hospital-registry study conducted at 33 centers across Turkey. Data on patient demographics, baseline characteristics, laboratory findings, and leukemia-cell cytogenetics were retrieved. Treatment response, survival outcome including overall survival (OS) and progression-free survival (PFS), and safety data were analyzed. Results: Overall, 36.7% of patients were categorized as Eastern Cooperative Oncology Group (ECOG) class 2-3, while 44.9% were in Rai stage 4. Fluorescence in situ hybridization revealed the presence of del(17p) in 39.8% of the patients. Patients received a median of 2.0 (range: 0-7) lines of pre-ibrutinib therapy. Median duration of therapy was 8.8 months (range: 0.4-58.0 months). The 1-year PFS and OS rates were 82.2% and 84.6%, respectively, while median PFS time was 30.0 (standard error, 95% confidence interval: 5.1, 20.0-40.0) months and median OS time was 37.9 (3.2, 31.5-44.2) months. Treatment response (complete or partial response), PFS time, and OS time were better with 0-2 lines versus 3-7 lines of prior therapy (p<0.001, p=0.001, and p<0.001, respectively), with ECOG class 0-1 versus class 2-3 (p=0.006, p=0.011, and p=0.001, respectively), and with Rai stage 0-2 versus 3-4 (p=0.002, p=0.001, and p=0.002, respectively). No significant difference was noted in treatment response rates or survival outcome with respect to the presence of comorbidity, bulky disease, or del(17p). While 176 adverse events (AEs) were reported in 74 (54.4%) patients, 46 of those 176 AEs were grade 3-4, including pneumonia (n=12), neutropenia (n=11), anemia (n=5), thrombocytopenia (n=5), and fever (n=5). Conclusion: This real-life analysis confirms the favorable efficacy and safety profile of long-term ibrutinib treatment while emphasizing the potential adverse impacts of poorer ECOG performance status, heavy treatment prior to ibrutinib, and advanced Rai stage on patient compliance, treatment response, and survival outcomes.
dc.description.sponsorshipJanssen Pharmaceutica Turkey
dc.description.sponsorshipThis study was supported by Janssen Pharmaceutica Turkey. The authors would like to thank Prof. Sule Oktay, MD, PhD, and Cala Ayhan, MD, from KAPPA Consultancy Training Research Ltd. (stanbul, Turkey) , who provided editorial support.
dc.identifier.doi10.4274/tjh.galenos.2021.2021.0007
dc.identifier.endpage285
dc.identifier.issn1300-7777
dc.identifier.issn1308-5263
dc.identifier.issue4
dc.identifier.pmid34448556
dc.identifier.scopus2-s2.0-85122065652
dc.identifier.scopusqualityQ3
dc.identifier.startpage273
dc.identifier.trdizinid508839
dc.identifier.urihttps://doi.org/10.4274/tjh.galenos.2021.2021.0007
dc.identifier.urihttps://search.trdizin.gov.tr/tr/yayin/detay/508839
dc.identifier.urihttps://hdl.handle.net/20.500.12418/27694
dc.identifier.volume38
dc.identifier.wosWOS:000730491500003
dc.identifier.wosqualityQ4
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakTR-Dizin
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherGalenos Yayincilik
dc.relation.ispartofTurkish Journal of Hematology
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectChronic lymphocytic leukemia
dc.subjectIbrutinib
dc.subjectBruton's tyrosine kinase inhibitor
dc.titleEfficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data
dc.typeArticle

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