Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial.
Tim Henrik BrümmendorfJorge E CortesDragana MilojkovicCarlo B Gambacorti-PasseriniRichard E ClarkPhilipp le CoutreJ Valentín García-GutiérrezCharles ChuahVamsi K KotaJeffrey H LiptonPhilippe RousselotMichael J MauroAndreas HochhausRafael Hurtado MonroyEric LeipSimon PurcellAnne YverAndrea ViqueiraMichael W Deiningernull nullPublished in: Leukemia (2022)
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.
Keyphrases
- chronic myeloid leukemia
- newly diagnosed
- end stage renal disease
- open label
- chronic kidney disease
- phase iii
- clinical trial
- phase ii
- squamous cell carcinoma
- magnetic resonance
- magnetic resonance imaging
- healthcare
- physical activity
- prognostic factors
- emergency department
- heart failure
- double blind
- machine learning
- contrast enhanced
- phase ii study
- combination therapy
- rectal cancer
- health insurance
- electronic health record