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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 03710naa a2200565 4500 | |
| 001 | oai:prod.swepub.kib.ki.se:147558934 | |
| 003 | SwePub | |
| 008 | 240701s2021 | |||||||||||000 ||eng| | |
| 024 | 7 | a http://kipublications.ki.se/Default.aspx?queryparsed=id:1475589342 URI |
| 024 | 7 | a https://doi.org/10.3324/haematol.2020.2594322 DOI |
| 040 | a (SwePub)ki | |
| 041 | a engb eng | |
| 042 | 9 SwePub | |
| 072 | 7 | a ref2 swepub-contenttype |
| 072 | 7 | a art2 swepub-publicationtype |
| 100 | 1 | a Tam, CS4 aut |
| 245 | 1 0 | a Zanubrutinib monotherapy for patients with treatment naïve chronic lymphocytic leukemia and 17p deletion |
| 264 | c 2020-10-13 | |
| 264 | 1 | b Ferrata Storti Foundation (Haematologica),c 2021 |
| 520 | a 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. | |
| 700 | 1 | a Robak, T4 aut |
| 700 | 1 | a Ghia, P4 aut |
| 700 | 1 | a Kahl, BS4 aut |
| 700 | 1 | a Walker, P4 aut |
| 700 | 1 | a Janowski, W4 aut |
| 700 | 1 | a Simpson, D4 aut |
| 700 | 1 | a Shadman, M4 aut |
| 700 | 1 | a Ganly, PS4 aut |
| 700 | 1 | a Laurenti, L4 aut |
| 700 | 1 | a Opat, S4 aut |
| 700 | 1 | a Tani, M4 aut |
| 700 | 1 | a Ciepluch, H4 aut |
| 700 | 1 | a Verner, E4 aut |
| 700 | 1 | a Simkovi, M4 aut |
| 700 | 1 | a Osterborg, Au Karolinska Institutet4 aut |
| 700 | 1 | a Trneny, M4 aut |
| 700 | 1 | a Tedeschi, A4 aut |
| 700 | 1 | a Paik, JC4 aut |
| 700 | 1 | a Kuwahara, SB4 aut |
| 700 | 1 | a Feng, SB4 aut |
| 700 | 1 | a Ramakrishnan, V4 aut |
| 700 | 1 | a Cohen, A4 aut |
| 700 | 1 | a Huang, J4 aut |
| 700 | 1 | a Hillmen, P4 aut |
| 700 | 1 | a Brown, JR4 aut |
| 710 | 2 | a Karolinska Institutet4 org |
| 773 | 0 | t Haematologicad : Ferrata Storti Foundation (Haematologica)g 106:9, s. 2354-2363q 106:9<2354-2363x 1592-8721x 0390-6078 |
| 856 | 4 | u https://haematologica.org/article/download/haematol.2020.259432/72472 |
| 856 | 4 8 | u http://kipublications.ki.se/Default.aspx?queryparsed=id:147558934 |
| 856 | 4 8 | u https://doi.org/10.3324/haematol.2020.259432 |
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