Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis

Naoto Takahashi, Jorge E. Cortes, Emiko Sakaida, Kenichi Ishizawa, Takaaki Ono, Noriko Doki, Itaru Matsumura, Valentín García-Gutiérrez, Gianantonio Rosti, Chiho Ono, Masayuki Ohkura, Yusuke Tanetsugu, Andrea Viqueira, Tim H. Brümmendorf

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Bosutinib has been investigated in multiple clinical trials globally, including Japan, for treatment of chronic myeloid leukemia (CML). A pooled analysis of seven Pfizer-sponsored clinical trials evaluated the safety of bosutinib in Japanese (n = 138) vs non-Japanese (n = 1210) patients with CML. First-line bosutinib was administered in 54.3% vs 41.4% of patients, and second-line or later bosutinib in the remainder. Median treatment duration was 1.4 vs 2.3 years, and median relative dose intensity 78.1% vs 90.0%. Any-grade treatment-emergent adverse events (TEAEs) occurred in 100.0% vs 98.9% (grade ≥ 3: 81.9% vs 75.2%). In both groups, the most common TEAEs relevant to bosutinib were gastrointestinal (92.8% vs 84.7%), liver function (72.5% vs 34.8%), rash (63.8% vs 37.4%), and myelosuppression (55.1% vs 50.7%). TEAEs led to dose reduction in 65.2% vs 50.6%, dose interruption in 78.3% vs 68.8%, and permanent treatment discontinuation in 30.4% vs 25.4% of patients. The safety profile of bosutinib in Japanese patients was generally consistent with that in non-Japanese patients, despite a higher incidence of gastrointestinal, liver function, and rash events. TEAEs were largely manageable with dose modifications and supportive care in both groups. These data may help optimize TEAE management and outcomes in Japanese patients receiving bosutinib for CML. Trial registration NCT02130557, NCT03128411, NCT00574873, NCT00261846, NCT01903733, NCT00811070, NCT02228382.

Original languageEnglish (US)
Pages (from-to)838-851
Number of pages14
JournalInternational Journal of Hematology
Issue number6
StatePublished - Jun 2022


  • Bosutinib
  • Chronic myeloid leukemia
  • Japan
  • Safety
  • Tyrosine kinase inhibitor

ASJC Scopus subject areas

  • Hematology


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