دورية أكاديمية
Pooled safety analysis of zanubrutinib monotherapy in patients with B-cell malignancies
| العنوان: | Pooled safety analysis of zanubrutinib monotherapy in patients with B-cell malignancies |
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| المؤلفون: | Tam, Constantine S, Dimopoulos, Meletios A., Garcia-Sanz, Ramon, Trotman, Judith, Opat, Stephen, Roberts, Andrew W, Owen, Roger G., Song, Yuqin, Xu, Wei, Zhu, Jun, Li, Jianyong, Qiu, Lugui, D'Sa, Shirley, Jurczak, Wojciech, Cull, Gavin, Marlton, Paula, Gottlieb, David J, Munoz, Javier, Phillips, Tycel, Du, Chenmu, Ji, Meng, Zhou, Lei, Guo, Haiyi, Zhu, Hongjie, Chan, Wai Y., Cohen, Aileen, Novotny, William, Huang, Jane, Tedeschi, Alessandra |
| سنة النشر: | 2021 |
| المجموعة: | Jagiellonian University Repository |
| مصطلحات موضوعية: | zanubrutinib, bruton tyrosine kinase, B-cell malignancy, safety |
| الوصف: | Zanubrutinib is a selective Bruton tyrosine kinase (BTK) inhibitor evaluated in multiple B-cell malignancy studies. We constructed a pooled safety analysis to better understand zanubrutinib-associated treatment-emergent adverse events (TEAEs) and identify treatment-limiting toxicities. Data were pooled from 6 studies (N=779). Assessments included type, incidence, severity, and outcome of TEAEs. Median age was 65 years; 20% were ≥75 years old. Most patients had Waldenström macroglobulinemia (33%), chronic lymphocytic leukemia/small lymphocytic lymphoma (29%), or mantle-cell lymphoma (19%). Median treatment duration was 26 months (range: 0.1-65); 16% of patients were treated for ≥3 years. Common nonhematologic TEAEs were upper respiratory tract infection (URI, 39%), rash (27%), bruising (25%), musculoskeletal pain (24%), diarrhea (23%), cough, pneumonia (21% each), urinary tract infection (UTI), fatigue (15% each). Most common grade ≥3 TEAEs were pneumonia (11%), hypertension (5%), URI, UTI, sepsis, diarrhea, and musculoskeletal pain (2% each). Atrial fibrillation and major hemorrhage occurred in 3% and 4% of patients, respectively. Atrial fibrillation, hypertension and diarrhea occurred at lower rates than those reported historically for ibrutinib. Grade ≥3 AEs included neutropenia (23%), thrombocytopenia (8%), and anemia (8%). Serious TEAEs included pneumonia (11%), sepsis (2%), and pyrexia (2%). Treatment discontinuations and dose reductions for AEs occurred in 10% and 8% of patients, respectively. Thirty-nine patients (4%) had fatal TEAEs, including pneumonia (n=9), sepsis (n=4), unspecified cause (n=4), and multiple organ dysfunction syndrome (n=5). This analysis demonstrates that zanubrutinib is generally well tolerated with a safety profile consistent with known BTK inhibitor toxicities; these were manageable and mostly reversible. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 2473-9529 2473-9537 |
| العلاقة: | Blood Advances, T. 6, nr 4, s. 1296-1308; https://ruj.uj.edu.pl/xmlui/handle/item/287991Test |
| DOI: | 10.1182/bloodadvances.2021005621 |
| DOI: | 10.1182/bloodadvances.2021005621/477740/Pooled-safety-analysis-of-zanubrutinib-monotherapy |
| الإتاحة: | https://doi.org/10.1182/bloodadvances.2021005621Test https://ruj.uj.edu.pl/xmlui/handle/item/287991Test |
| رقم الانضمام: | edsbas.45DF648C |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 24739529 24739537 |
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| DOI: | 10.1182/bloodadvances.2021005621 |