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Zanubrutinib monoth...
Zanubrutinib monotherapy for patients with treatment naïve chronic lymphocytic leukemia and 17p deletion
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Tam, CS (author)
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Robak, T (author)
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Ghia, P (author)
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show more...
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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, A (author)
- Karolinska Institutet
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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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(creator_code:org_t)
- 2020-10-13
- 2021
- English.
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In: Haematologica. - : Ferrata Storti Foundation (Haematologica). - 1592-8721 .- 0390-6078. ; 106:9, s. 2354-2363
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Abstract
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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.
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- art (subject category)
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- By the author/editor
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Tam, CS
-
Robak, T
-
Ghia, P
-
Kahl, BS
-
Walker, P
-
Janowski, W
-
show more...
-
Simpson, D
-
Shadman, M
-
Ganly, PS
-
Laurenti, L
-
Opat, S
-
Tani, M
-
Ciepluch, H
-
Verner, E
-
Simkovi, M
-
Osterborg, A
-
Trneny, M
-
Tedeschi, A
-
Paik, JC
-
Kuwahara, SB
-
Feng, SB
-
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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show less...
- Articles in the publication
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Haematologica
- By the university
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Karolinska Institutet