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Zanubrutinib monotherapy for patients with treatment naïve chronic lymphocytic leukemia and 17p deletion
CS. Tam, T. Robak, P. Ghia, BS. Kahl, P. Walker, W. Janowski, D. Simpson, M. Shadman, PS. Ganly, L. Laurenti, S. Opat, M. Tani, H. Ciepluch, E. Verner, M. Šimkovič, A. Österborg, M. Trněný, A. Tedeschi, JC. Paik, SB. Kuwahara, S. Feng, V....
Jazyk angličtina Země Itálie
Typ dokumentu časopisecké články
NLK
Directory of Open Access Journals
od 1994
Free Medical Journals
od 1994
Freely Accessible Science Journals
od 1994
PubMed Central
od 2009
Europe PubMed Central
od 2009
Open Access Digital Library
od 1994-01-01
ROAD: Directory of Open Access Scholarly Resources
od 1996
- 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
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.
4th Department of Internal Medicine Hematology University Hospital Hradec Kralove Czech Republic
ASST Grande Ospedale Metropolitano Niguarda Milan
Calvary Mater Newcastle Waratah NSW
Concord Repatriation General Hospital Concord NSW Australia
Copernicus Wojewódzkie Centrum Onkologii Gdánsk
Dana Farber Cancer Institute Boston MA
Department of Haematology Christchurch Hospital Christchurch
Department of Hematology Karolinska University Hospital Stockholm
Department of Medicine University of Washington Seattle WA
Department of Oncology Pathology Karolinska Institutet Stockholm Sweden
Faculty of Medicine Charles University Prague Czech Republic
Fondazione Policlinico Universitario A Gemelli IRCCS Rome
Fred Hutchinson Cancer Research Center Seattle WA USA
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
Peter MacCallum Cancer Centre Melbourne Victoria Australia
Royal Melbourne Hospital Parkville Victoria Australia
St James's University Hospital Leeds
St Vincent's Hospital Melbourne Fitzroy Victoria
Università Vita Salute San Raffaele and IRCCS Ospedale San Raffaele Milano
University of Melbourne Parkville Victoria Australia
Citace poskytuje Crossref.org
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