Zanubrutinib monotherapy for patients with treatment naïve chronic lymphocytic leukemia and 17p deletion
Jazyk angličtina Země Itálie Médium electronic
Typ dokumentu časopisecké články
PubMed
33054121
PubMed Central
PMC8409041
DOI
10.3324/haematol.2020.259432
Knihovny.cz E-zdroje
- MeSH
- chronická lymfatická leukemie * farmakoterapie genetika MeSH
- lidé MeSH
- piperidiny MeSH
- pyrazoly MeSH
- pyrimidiny škodlivé účinky MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- piperidiny MeSH
- pyrazoly MeSH
- pyrimidiny MeSH
- zanubrutinib MeSH Prohlížeč
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.
ASST Grande Ospedale Metropolitano Niguarda Milan
Calvary Mater Newcastle Waratah NSW
Concord Repatriation General Hospital Concord NSW Australia; University of Sydney Concord NSW
Copernicus Wojewódzkie Centrum Onkologii Gdánsk
Dana Farber Cancer Institute Boston MA
Department of Haematology Christchurch Hospital Christchurch
Fondazione Policlinico Universitario A Gemelli IRCCS Rome
Hematology Unit Santa Maria delle Croci Hospital Ravenna
Medical University of Lodz Lodz
Monash Health Clayton Victoria Australia; Monash University Clayton Victoria
Peninsula Private Hospital Frankston Victoria
St James's University Hospital Leeds
Università Vita Salute San Raffaele and IRCCS Ospedale San Raffaele Milano
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ClinicalTrials.gov
NCT03336333