Chronic phase CML: bosutinib, imatinib yield similar effect on QoL

  • Cortes JE & al.
  • J Cancer Res Clin Oncol
  • 15 Apr 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Self-reported data.

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