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Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial

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Author(s)
Charles ChuahLiang Piu KohTontanai NumbenjaponDae Young ZangKiat Hoe OngYoung Rok DoMasayuki OhkuraChiho OnoAndrea ViqueiraJorge E. CortesTim H. Brümmendorf
Keimyung Author(s)
Do, Young Rok
Department
Dept. of Internal Medicine (내과학)
Journal Title
Int J Hematol
Issued Date
2021
Volume
114
Keyword
AsianBosutinibChronic myeloid leukemiaFirst-lineImatinib
Abstract
Bosutinib is approved in the United States, Europe, Japan, and other countries for treatment of newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML), and CML resistant/intolerant to prior therapy. In the phase 3 BFORE trial (Clinicaltrials.gov, NCT02130557), patients were randomized 1:1 to first-line bosutinib or imatinib 400 mg once daily. We examined efficacy, safety, and patient-reported outcomes of bosutinib vs imatinib and pharmacokinetics of bosutinib in the Asian (n = 33 vs 34) and non-Asian (n = 235 vs 234) subpopulations of BFORE followed for at least 24 months. At the data cutoff date, 72.7 vs 66.7% of Asian and 70.6 vs 66.4% of non-Asian patients remained on treatment. The major molecular response rate at 24 months favored bosutinib vs imatinib among Asian (63.6 vs 38.2%) and non-Asian (60.9 vs 52.6%) patients, as did the complete cytogenetic response rate by 24 months (86.7 vs 76.7%, 81.5 vs 76.3%). Treatment-emergent adverse events in both subpopulations were consistent with the primary BFORE results. Trough bosutinib concentration levels tended to be higher in Asian patients. Health-related quality of life was maintained after 12 months of bosutinib in both subpopulations. These results support bosutinib as a first-line treatment option in Asian patients with CP CML.
Keimyung Author(s)(Kor)
도영록
Publisher
School of Medicine (의과대학)
Citation
Charles Chuah et al. (2021). Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial. Int J Hematol, 114, 65–78. doi: 10.1007/s12185-021-03144-4
Type
Article
ISSN
1865-3774
Source
https://link.springer.com/article/10.1007%2Fs12185-021-03144-4
DOI
10.1007/s12185-021-03144-4
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43730
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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