- According to patient-reported outcomes (PROs) from the phase 3 BFORE study of first-line bosutinib vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP), both treatment groups demonstrated preserved or improved health-related QoL (HRQoL).
Why this matters
- In the BFORE study, bosutinib demonstrated a significantly higher rate of major molecular response at 12 months vs imatinib.
- Analysis of PROs as an exploratory objective in the phase 3 BFORE trial of bosutinib (n=246) vs imatinib (n=241) in patients with newly diagnosed CML-CP.
- PROs were assessed using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) and EuroQoL-5 Dimensions (EQ-5D) questionnaires.
- Funding: Avillion LLP; Pfizer Inc.
- Improvement/maintenance of HRQoL at month 12 in both treatment groups per all FACT-Leu combined and subscale scores.
- No significant difference between treatment groups for any FACT-Leu subscale at month 12 in repeated-measures mixed-effects models.
- Significant improvement in mean EQ-5D VAS scores in both treatment groups at 12 months.
- In repeated-measures mixed-effects models for EQ-5D scores, there was no significant difference between treatment groups for mobility, self-care, usual activities, pain/discomfort, anxiety/depression, health-state today, or utility scores at 12 months.
- Self-reported data.