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Zanubrutinib monoth...
Zanubrutinib monotherapy for patients with treatment naïve chronic lymphocytic leukemia and 17p deletion
- Article/chapterEnglish2021
Publisher, publication year, extent ...
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2020-10-13
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Ferrata Storti Foundation (Haematologica),2021
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LIBRIS-ID:oai:prod.swepub.kib.ki.se:147558934
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http://kipublications.ki.se/Default.aspx?queryparsed=id:147558934URI
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https://doi.org/10.3324/haematol.2020.259432DOI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Patients with chronic lymphocytic leukemia or small lymphocytic lymphoma whose tumors carry deletion of chromosome 17p13.1 [del(17p)] have an unfavorable prognosis and respond poorly to standard chemoimmunotherapy. Zanubrutinib is a selective next-generation Bruton tyrosine kinase inhibitor. We evaluated the safety and efficacy of zanubrutinib 160 mg twice daily in treatment-naïve patients with del(17p) disease enrolled in a dedicated, nonrandomized cohort (Arm C) of the phase 3 SEQUOIA trial. A total of 109 patients (median age, 70 years; range, 42 – 86) with centrally confirmed del(17p) were enrolled and treated. After a median of 18.2 months (range, 5.0 – 26.3), seven patients had discontinued study treatment due to progressive disease, four due to an adverse event, and one due to withdrawal of consent. The overall response rate was 94.5% with 3.7% of patients achieving complete response with or without incomplete hematologic recovery. The estimated 18-month progression-free survival rate was 88.6% (95% CI, 79.0 – 94.0) and the estimated 18-month overall survival rate was 95.1% (95% CI, 88.4 – 98.0). Most common all-grade adverse events included contusion (20.2%), upper respiratory tract infection (19.3%), neutropenia/neutrophil count decreased (17.4%), and diarrhea (16.5%). Grade ≥ 3 adverse events were reported in 53 patients (48.6%), most commonly neutropenia (12.9%) and pneumonia (3.7%). An adverse event of atrial fibrillation was reported in three patients (2.8%). Zanubrutinib was active and well tolerated in this large, prospectively enrolled treatment cohort of previously untreated patients with del(17p) chronic lymphocytic leukemia/small lymphocytic lymphoma. This trial was registered at ClinicalTrials.gov as #NCT03336333.
Added entries (persons, corporate bodies, meetings, titles ...)
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Robak, T
(author)
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Ghia, P
(author)
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Kahl, BS
(author)
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Walker, P
(author)
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Janowski, W
(author)
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Simpson, D
(author)
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Shadman, M
(author)
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Ganly, PS
(author)
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Laurenti, L
(author)
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Opat, S
(author)
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Tani, M
(author)
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Ciepluch, H
(author)
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Verner, E
(author)
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Simkovi, M
(author)
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Osterborg, AKarolinska Institutet
(author)
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Trneny, M
(author)
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Tedeschi, A
(author)
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Paik, JC
(author)
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Kuwahara, SB
(author)
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Feng, SB
(author)
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Ramakrishnan, V
(author)
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Cohen, A
(author)
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Huang, J
(author)
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Hillmen, P
(author)
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Brown, JR
(author)
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Karolinska Institutet
(creator_code:org_t)
Related titles
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In:Haematologica: Ferrata Storti Foundation (Haematologica)106:9, s. 2354-23631592-87210390-6078
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Tam, CS
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Robak, T
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Ghia, P
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Kahl, BS
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Walker, P
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Janowski, W
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show more...
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Simpson, D
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Shadman, M
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Ganly, PS
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Laurenti, L
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Opat, S
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Tani, M
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Ciepluch, H
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Verner, E
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Simkovi, M
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Osterborg, A
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Trneny, M
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Tedeschi, A
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Paik, JC
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Kuwahara, SB
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Feng, SB
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Ramakrishnan, V
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Cohen, A
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Huang, J
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Hillmen, P
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Brown, JR
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- Articles in the publication
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Haematologica
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Karolinska Institutet