BELA Trial: Similar Rate of CCyR With Bosutinib vs Imatinib in Newly Diagnosed Patients With Ph-Positive CML-CP

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Summary of Key Conclusions:

Bosutinib associated with similar complete cytogenetic response (CCyR) vs imatinib at 12 months in newly diagnosed patients with Philadelphia chromosome (Ph)–positive chronic-phase chronic myeloid leukemia (CML-CP)

Significantly higher CCyR with bosutinib vs imatinib in evaluable patients

Significantly higher major molecular response rate (MMR) in intent-to-treat and evaluable populations

Lower rates of transformation to accelerated phase or blast phase (AP/BP) CML, discontinuation due to treatment failure, and death due to CML progression

No significant difference in OS between treatment arms

Bosutinib safety analysis showed acceptable but distinct toxicity profile

Higher incidence of adverse events, serious adverse events, and treatment discontinuations due to adverse events compared with imatinib

Higher rates of diarrhea, elevated transaminases, and vomiting than imatinib

Lower rates of neutropenia, muscle spasms, and edema

No treatment-related deaths

Authors assert that bosutinib may be an additional therapeutic option for patients with newly diagnosed CML-CP

http://www.clinicaloptions.com/Oncology/Conference%20Coverage/Hematology%202010/Tracks/CML/Capsules/208.aspx