Impact of age and comorbidities on the efficacy and tolerability of bosutinib in previously treated patients with chronic myeloid leukemia: results from the phase 4 BYOND study

Summary. In the Phase 4 BYOND study the efficacy and safety of bosutinib in treatment-experienced patients with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia (CML) adjusted by age and the Charlson Comorbidity Index scores (without age component, mCCI) was evaluated. Cumulative major molecular response rates (MMR) at any time on treatment were 73.6, 64.5, and 74.1% in patients <65, 65–74, and ≥75 years of age, and 77.9, 63.0 and 59.3% in patients with mCCI scores 2, 3 and ≥4, respectively. Patients <65, 65–74, and ≥75 years of age experienced grade 3/4 treatment-emergent adverse events (TEAEs) at rates of 74.7, 78.8, and 96.4% and permanent discontinuations due to AEs at rates of 22.1, 39.4, and 46.4%, respectively. In patients with mCCI 2, 3, and ≥4, respective rates of grade 3/4 TEAEs were 77.8, 77.8, and 86.7%, and permanent discontinuations due to AEs were 25.3, 33.3, and 43.3%. In conclusion, a substantial proportion of patients maintained/achieved cytogenetic and molecular responses across age groups and mCCI scores. Older patients (≥75 years) and those with high comorbidity burden (mCCI ≥4) are a group of individuals who may require more careful monitoring of their condition due to an increased risk of TEAEs.

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