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Bending the Curve Trial by Trial
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BFORE

Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial

Phase 3N = 536NCT02130557

Population
Newly diagnosed chronic-phase CML
Design
Open-label, multinational phase 3 study (ongoing at the time of the primary report); 1:1 randomisation to bosutinib 400 mg once daily or imatinib 400 mg once daily (full text: 'randomly assigned 1:1 to receive 400 mg of bosutinib or imatinib once daily'; median imatinib dose intensity 400 mg/day). Per protocol, efficacy was assessed in the modified intent-to-treat population: Ph-positive patients with typical (e13a2/e14a2) transcripts.
Primary endpoint
MMR
Arms
  • Bosutinib (experimental, n = 268): Bosutinib 400 mg once daily
  • Imatinib (control, n = 268): Imatinib 400 mg once daily
People
Cortes JE, senior author Brümmendorf TH
Δ MMR+10.3 pointsΔ CCyR+10.8 points
Show the numbers
Results reported for BFORE
EndpointAnalysisBosutinibImatinibEffect
MMRModified intent-to-treat: Philadelphia chromosome-positive patients with typical (e13a2/e14a2) transcripts (bosutinib 246; imatinib 241), the protocol-specified efficacy populationMajor molecular response rate at 12 months (primary end point)primaryCortes 201847.2%36.9%P=0.02Cumulative incidence function of MMR also reported: hazard ratio 1.34 (95% CI 1.06 to 1.69), Gray's test P=0.0173, indicating a shorter time to response with bosutinib. This ratio comes from a cumulative-incidence (competing-risk) analysis of response, not a survival endpoint; a ratio above 1 means earlier response with bosutinib.
CCyRModified intent-to-treat: Philadelphia chromosome-positive patients with typical (e13a2/e14a2) transcripts (bosutinib 246; imatinib 241), the protocol-specified efficacy populationComplete cytogenetic response rate by 12 monthsprimaryCortes 201877.2%66.4%P=0.0075Cumulative incidence function of CCyR also reported: hazard ratio 1.38 (95% CI 1.13 to 1.69), Gray's test P<0.001. This ratio comes from a cumulative-incidence (competing-risk) analysis of response, not a survival endpoint; a ratio above 1 means earlier response with bosutinib.
Results reported for BFORE
EndpointAnalysisBosutinibImatinibEffect
MMRModified intent-to-treat: Philadelphia chromosome-positive patients with typical (e13a2/e14a2) transcripts (bosutinib 246; imatinib 241), the protocol-specified efficacy populationMajor molecular response rate at 12 months (primary end point)primaryCortes 201847.2%36.9%P=0.02Cumulative incidence function of MMR also reported: hazard ratio 1.34 (95% CI 1.06 to 1.69), Gray's test P=0.0173, indicating a shorter time to response with bosutinib. This ratio comes from a cumulative-incidence (competing-risk) analysis of response, not a survival endpoint; a ratio above 1 means earlier response with bosutinib.
CCyRModified intent-to-treat: Philadelphia chromosome-positive patients with typical (e13a2/e14a2) transcripts (bosutinib 246; imatinib 241), the protocol-specified efficacy populationComplete cytogenetic response rate by 12 monthsprimaryCortes 201877.2%66.4%P=0.0075Cumulative incidence function of CCyR also reported: hazard ratio 1.38 (95% CI 1.13 to 1.69), Gray's test P<0.001. This ratio comes from a cumulative-incidence (competing-risk) analysis of response, not a survival endpoint; a ratio above 1 means earlier response with bosutinib.
Primary publication: Cortes JE, Gambacorti-Passerini C, Deininger MW, Mauro MJ, Chuah C, Kim DW, et al. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018;36(3):231-237. PubMedDOI

Appears in

Sources

  1. Cortes JE, Gambacorti-Passerini C, Deininger MW, Mauro MJ, Chuah C, Kim DW, et al. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018;36(3):231-237.

    PubMedDOI