The real-world experience with single agent ibrutinib in relapsed/refractory CLL

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ntroduction/background: The emergence of novel agents targeting the B-cell receptor pathway and BCL-2 has significantly changed the therapeutic landscape of CLL. We evaluated the safety and efficacy of single-agent ibrutinib in relapsed/refractory CLL in real-world settings. Patients/methods: A total of 200 relapsed/refractory CLL patients with a median age of 68 were included in this retrospective, multicenter, non-interventional study. Data of the study were captured from the patient charts of the participating centers. Results: The median for lines of previous chemotherapy was 2 (1-6); 62 (31.8%) patients had del17p and/or p53 mutations (del17p+/p53mut). Of the study group, 146 (75%) patients achieved at least PR, while 16 (8.7%) patients discontinued ibrutinib due to TEA. The most common drug-related adverse events were neutropenia (n: 31; 17.4%) and thrombocytopenia (n: 40; 22.3%), which were ? grade 3 in 9 (5%) and 5 (3.9%) patients, respectively. Pneumonia (n: 42; 23.7%) was the most common nonhematologic TEA. Atrial fibrillation (n: 5; 2.8%) and bleeding (n: 11; 6.3%) were relatively rare during the study period. Within a median follow-up period of 17 (1-74) months, 42 (21%) patients died. The estimated median OS of the study cohort was 52 months. Only the response to ibrutinib (CR/PR vs. SD/PD) was significantly associated with OS.


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Bruton Tyrosine Kinase, Chronic Lymphocytic Leukemia, Ibrutinib, Relapsed/refractory, P53 Mutation


Clinical Lymphoma, Myeloma and Leukemia

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Akpinar, S., Dogu, M. H., Celik, S., Ekinci, O., Hindilerden, I. Y., Dal, M. S., Davulcu, E. A., Tekinalp, A., Hindilerden, F., Ozcan, B. G., Hacibekiroglu, T., Erkurt, M. A., Bagci, M., Namdaroglu, S., Korkmaz, G., Bilgir, O., Cagliyan, G. A., Ozturk, H., Serin, I., Tiryaki, T. O., … Altuntas, F. (2021). The Real-World Experience With Single Agent Ibrutinib in Relapsed/Refractory CLL. Clinical lymphoma, myeloma & leukemia, S2152-2650(21)02040-1. Advance online publication.