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Zanubrutinib Versus Ibrutinib in Symptomatic Waldenström Macroglobulinemia: Final Analysis From the Randomized Phase III ASPEN Study
MA. Dimopoulos, S. Opat, S. D'Sa, W. Jurczak, HP. Lee, G. Cull, RG. Owen, P. Marlton, BE. Wahlin, R. Garcia-Sanz, H. McCarthy, S. Mulligan, A. Tedeschi, JJ. Castillo, J. Czyz, C. Fernández de Larrea, D. Belada, E. Libby, J. Matous, M. Motta, T....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, randomizované kontrolované studie, časopisecké články
NLK
Free Medical Journals
od 2004 do Před 1 rokem
Open Access Digital Library
od 1999-01-01
PubMed
37478390
DOI
10.1200/jco.22.02830
Knihovny.cz E-zdroje
- MeSH
- lidé MeSH
- piperidiny terapeutické užití MeSH
- pyrimidiny škodlivé účinky MeSH
- Waldenströmova makroglobulinemie * farmakoterapie genetika MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
The phase III ASPEN study demonstrated the comparable efficacy and improved safety of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia (WM). Here, we report long-term follow-up outcomes from ASPEN. The primary end point was the sum of very good partial response (VGPR) + complete response (CR) rates; secondary and exploratory end points were also reported. Cohort 1 comprised 201 patients (myeloid differentiation primary response 88-mutant WM: 102 receiving zanubrutinib; 99 receiving ibrutinib); cohort 2 comprised 28 patients (myeloid differentiation primary response 88 wild-type WM: 28 zanubrutinib; 26 efficacy evaluable). At 44.4-month median follow-up, VGPR + CR rates were 36.3% with zanubrutinib versus 25.3% with ibrutinib in cohort 1 and 30.8% with one CR in cohort 2. In patients with CXC motif chemokine receptor 4 mutation, VGPR + CR rates were 21.2% with zanubrutinib versus 10.0% with ibrutinib (cohort 1). Median progression-free survival and overall survival were not reached. Any-grade adverse events (AEs) of diarrhea (34.7% v 22.8%), muscle spasms (28.6% v 11.9%), hypertension (25.5% v 14.9%), atrial fibrillation/flutter (23.5% v 7.9%), and pneumonia (18.4% v 5.0%) were more common with ibrutinib versus zanubrutinib; neutropenia (20.4% v 34.7%) was less common with ibrutinib versus zanubrutinib (cohort 1). Zanubrutinib was associated with lower risk of AE-related treatment discontinuation. Overall, these findings confirm the long-term response quality and tolerability associated with zanubrutinib.
AO Spedali Civili di Brescia Lombardia Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
City of Hope National Medical Center Duarte CA
Collegium Medicum in Bydgoszcz Nicolaus Copernicus University in Toruń Bydgoszcz Poland
Colorado Blood Cancer Institute Denver CO
Concord Repatriation General Hospital Sydney NSW Australia
Dana Farber Cancer Institute Boston MA
Flinders Medical Centre Adelaide SA Australia
FN Hradec Králové Hradec Králové Czechia
Fred Hutchinson Cancer Center Seattle WA
Hospital Clínic de Barcelona IDIBAPS Barcelona Spain
Hospital Universitario de Salamanca Salamanca Spain
Karolinska Universitetssjukhuset and Karolinska Institutet Stockholm Sweden
Maria Sklodowska Curie National Institute of Oncology Krakow Poland
Monash Health and Monash University Clayton VIC Australia
National and Kapodistrian University of Athens Athens Greece
Ospedale Civile Santa Maria delle Croci AUSL Ravenna Ravenna Italy
Princess Alexandra Hospital and University of Queensland Brisbane QLD Australia
Royal Bournemouth and Christchurch Hospital Bournemouth United Kingdom
Royal North Shore Hospital Sydney NSW Australia
Sir Charles Gairdner Hospital University of Western Australia Perth WA Australia
Sorbonne University Pitié Salpêtrière Hospital Paris France
St James University Hospital Leeds United Kingdom
The Alfred Hospital Melbourne VIC Australia
Citace poskytuje Crossref.org
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