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The chronic phase of chronic myeloid leukemia (CML) is durably controlled in most patients by front-line tyrosine kinase inhibitor (TKI) therapy targeting BCR-ABL. For CML patients who are resistant to or intolerant of initial treatment, the dual SRC/ABL TKI bosutinib is approved as a second-line or subsequent therapy.
To assess the front-line activity of bosutinib in CML, investigators conducted an industry-sponsored, international, randomized phase III trial (BFORE) in which 536 patients with newly diagnosed chronic-phase disease received 400 mg daily of bosutinib or imatinib.
Major molecular response rate at 12 months (the primary endpoint) was higher with bosutinib than imatinib (47.2% vs. 36.9%; P=0.02), as was complete cytogenetic respo…