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A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study
CS. Tam, S. Opat, S. D'Sa, W. Jurczak, HP. Lee, G. Cull, RG. Owen, P. Marlton, BE. Wahlin, RG. Sanz, H. McCarthy, S. Mulligan, A. Tedeschi, JJ. Castillo, J. Czyz, C. Fernández de Larrea, D. Belada, E. Libby, JV. Matous, M. Motta, T. Siddiqi, M....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
NLK
Free Medical Journals
od 1946 do Před 1 rokem
Freely Accessible Science Journals
od 1946 do Před 1 rokem
Open Access Digital Library
od 1946-01-01
Open Access Digital Library
od 1946-01-01
ROAD: Directory of Open Access Scholarly Resources
PubMed
32731259
DOI
10.1182/blood.2020006844
Knihovny.cz E-zdroje
- MeSH
- adenin aplikace a dávkování analogy a deriváty MeSH
- dospělí MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- míra přežití MeSH
- následné studie MeSH
- piperidiny aplikace a dávkování MeSH
- prognóza MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití MeSH
- pyrazoly aplikace a dávkování MeSH
- pyrimidiny aplikace a dávkování MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Waldenströmova makroglobulinemie farmakoterapie patologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
Bruton tyrosine kinase (BTK) inhibition is an effective treatment approach for patients with Waldenström macroglobulinemia (WM). The phase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, with zanubrutinib, a novel highly selective BTK inhibitor, in patients with WM. Patients with MYD88L265P disease were randomly assigned 1:1 to treatment with ibrutinib or zanubrutinib. The primary end point was the proportion of patients achieving a complete response (CR) or a very good partial response (VGPR) by independent review. Key secondary end points included major response rate (MRR), progression-free survival (PFS), duration of response (DOR), disease burden, and safety. A total of 201 patients were randomized, and 199 received ≥1 dose of study treatment. No patient achieved a CR. Twenty-nine (28%) zanubrutinib patients and 19 (19%) ibrutinib patients achieved a VGPR, a nonstatistically significant difference (P = .09). MRRs were 77% and 78%, respectively. Median DOR and PFS were not reached; 84% and 85% of ibrutinib and zanubrutinib patients were progression free at 18 months. Atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, and pneumonia, as well as adverse events leading to treatment discontinuation, were less common among zanubrutinib recipients. Incidence of neutropenia was higher with zanubrutinib, although grade ≥3 infection rates were similar in both arms (1.2 and 1.1 events per 100 person-months). These results demonstrate that zanubrutinib and ibrutinib are highly effective in the treatment of WM, but zanubrutinib treatment was associated with a trend toward better response quality and less toxicity, particularly cardiovascular toxicity.
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
ASST Spedali Civili di Brescia Lombardia Italy
Bing Center for Waldenstrom Macroglobulinemia Dana Farber Cancer Institute Boston MA
City of Hope National Medical Center Duarte CA
Clinical Haematology Unit Monash University Clayton VIC Australia
Colorado Blood Cancer Institute Denver CO
Comprehensive Cancer Center Ulm Universitätsklinikum Ulm Ulm Germany
Department of Clinical Therapeutics National and Kapodistrian University of Athens Athens Greece
Department of Haematology Concord Repatriation General Hospital Sydney Concord NSW Australia
Department of Haematology Princess Alexandra Hospital Brisbane QLD Australia
Department of Lymphoma Myeloma University of Western Australia Perth WA Australia
Department of Medicine Harvard Medical School Boston MA
Department of Medicine University of Melbourne Parkville VIC Australia
Department of Medicine University of Washington and the Seattle Cancer Care Alliance Seattle WA
Flinders Medical Centre Adelaide SA Australia
Haematology Department University of Sydney Concord NSW Australia
Hospital Universitario de Salamanca Salamanca Spain
Maria Sklodowska Curie National Institute of Oncology Krakow Poland
Monash Health Clayton VIC Australia
Ospedale Civile S Maria delle Croci Azienda Unità Sanitaria Locale Ravenna Italy
Peter MacCallum Cancer Centre Melbourne VIC Australia
Royal Bournemouth and Christchurch Hospital Bournemouth United Kingdom
Royal Melbourne Hospital Parkville VIC Australia
Royal North Shore Hospital Sydney NSW Australia
School of Medicine University of Queensland Brisbane QLD Australia
Service d'Hématologie Clinique Sorbonne University Pitié Salpêtrière Hospital Paris France
Sir Charles Gairdner Hospital Perth WA Australia
St James's University Hospital Leeds United Kingdom
St Vincent's Hospital Fitzroy VIC Australia
Szpital Uniwersytecki No 2 im Dr Jana Biziela Bydgoszcz Poland
University College London Hospital Foundation Trust London United Kingdom
Citace poskytuje Crossref.org
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