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

Charles Chuah, Liang Piu Koh, Tontanai Numbenjapon, Dae Young Zang, Kiat Hoe Ong, Young Rok Do, Masayuki Ohkura, Chiho Ono, Andrea Viqueira, Jorge E. Cortes, Tim H. Brümmendorf

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)65-78
Number of pages14
JournalInternational Journal of Hematology
Volume114
Issue number1
DOIs
StatePublished - Jul 2021

Keywords

  • Asian
  • Bosutinib
  • Chronic myeloid leukemia
  • First-line
  • Imatinib

ASJC Scopus subject areas

  • Hematology

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