1. Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial.
- Author
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Chuah C, Koh LP, Numbenjapon T, Zang DY, Ong KH, Do YR, Ohkura M, Ono C, Viqueira A, Cortes JE, and Brümmendorf TH
- Subjects
- Adult, Aged, Aged, 80 and over, Aniline Compounds adverse effects, Aniline Compounds blood, Antineoplastic Agents adverse effects, Antineoplastic Agents blood, Asia epidemiology, Female, Humans, Imatinib Mesylate adverse effects, Imatinib Mesylate blood, Leukemia, Myelogenous, Chronic, BCR-ABL Positive epidemiology, Male, Middle Aged, Nitriles adverse effects, Nitriles blood, Protein Kinase Inhibitors adverse effects, Protein Kinase Inhibitors blood, Quinolines adverse effects, Quinolines blood, Treatment Outcome, Young Adult, Aniline Compounds therapeutic use, Antineoplastic Agents therapeutic use, Imatinib Mesylate therapeutic use, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Nitriles therapeutic use, Protein Kinase Inhibitors therapeutic use, Quinolines therapeutic use
- 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.
- Published
- 2021
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