Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial
Tim H. Brümmendorf, Jörge E. Cortes, Dragana Milojković, Carlo Gambacorti‐Passerini, Richard E. Clark, Philipp le Coutre, Valentín García‐Gutiérrez, Charles Chuah, Vamsi Kota, Jeffrey H. Lipton, Philippe Rousselot, Michael J. Mauro, Andreas Hochhaus, Rafael Hurtado Monroy, Eric Leip, Simon Purcell, Anne Yver, Andrea Viqueira, Michael W. Deininger, BFORE study investigators
Abstract
Abstract This analysis from the multicenter, open-label, phase 3 BFORE trial reports efficacy and safety of bosutinib in patients with newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML) after five years’ follow-up. Patients were randomized to 400-mg once-daily bosutinib ( n = 268) or imatinib ( n = 268; three untreated). At study completion, 59.7% of bosutinib- and 58.1% of imatinib-treated patients remained on study treatment. Median duration of treatment and time on study was 55 months in both groups. Cumulative major molecular response (MMR) rate by 5 years was higher with bosutinib versus imatinib (73.9% vs. 64.6%; odds ratio, 1.57 [95% CI, 1.08–2.28]), as were cumulative MR 4 (58.2% vs. 48.1%; 1.50 [1.07–2.12]) and MR 4.5 (47.4% vs. 36.6%; 1.57 [1.11–2.22]) rates. Superior MR with bosutinib versus imatinib was consistent across Sokal risk groups, with greatest benefit seen in patients with high risk. Treatment-emergent adverse events (TEAEs) were consistent with 12-month data. After 5 years of follow-up there was an increase in the incidence of cardiac, effusion, renal, and vascular TEAEs in bosutinib- and imatinib-treated patients, but overall, no new safety signals were identified. These final results support 400-mg once-daily bosutinib as standard-of-care in patients with newly diagnosed CP CML. This trial was registered at www.clinicaltrials.gov as #NCT02130557.