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

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dc.authorid0000-0003-1864-0316
dc.authorscopusid20434783000
dc.authorscopusid57212110206
dc.authorscopusid57211043873
dc.authorscopusid57222295454
dc.authorscopusid7004568106
dc.authorscopusid26030049400
dc.authorscopusid6505893072
dc.authorwosidBasturk, Abdulkadir/B-1962-2018
dc.contributor.authorTombak, Anıl
dc.contributor.authorPepedil Tanrıkulu, Funda
dc.contributor.authorDurusoy, Salih Sertaç
dc.contributor.authorDinçyürek, Hüseyin Derya
dc.contributor.authorKaya, Emin
dc.contributor.authorÜmit, Elif Gülsüm
dc.contributor.authorFerhanoğlu, Burhan
dc.contributor.authorAkpınar, Seval
dc.contributor.authorTurgut, Burhan
dc.date.accessioned2022-05-11T14:40:01Z
dc.date.available2022-05-11T14:40:01Z
dc.date.issued2021
dc.departmentFakülteler, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıkları Ana Bilim Dalı
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.issue4en_US
dc.identifier.pmid34448556
dc.identifier.scopus2-s2.0-85122065652
dc.identifier.scopusqualityQ3
dc.identifier.startpage273
dc.identifier.urihttps://doi.org/10.4274/tjh.galenos.2021.2021.0007
dc.identifier.urihttps://hdl.handle.net/20.500.11776/8832
dc.identifier.volume38
dc.identifier.wosWOS:000730491500003
dc.identifier.wosqualityQ4
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.institutionauthorAkpınar, Seval
dc.institutionauthorTurgut, Burhan
dc.language.isoen
dc.publisherGalenos Yayincilik
dc.relation.ispartofTurkish Journal of Hematology
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectChronic lymphocytic leukemia
dc.subjectIbrutinib
dc.subjectBruton's tyrosine kinase inhibitor
dc.subjectFludarabine Plus Cyclophosphamide
dc.subjectOpen-Label
dc.subjectFollow-Up
dc.subjectCll
dc.subjectChemoimmunotherapy
dc.subjectRituximab
dc.subjectTrial
dc.subjectLymphoma
dc.subjectPhase-3
dc.titleEfficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data
dc.title.alternativeKronik Lenfositik Lösemili Hastalarda İbrutinib Tedavisinin Etkililiği ve Güvenilirliği: Gerçek Hayat Verilerinin Retrospektif Analizi]
dc.typeArticle

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