Brummendorf, Tim H, Cortes, Jorge E, Milojkovic, Dragana, Gambacorti-Passerini, Carlo, Clark, Richard E 
ORCID: 0000-0002-1261-3299, le Coutre, Philipp, Garcia-Gutierrez, Valentin, Chuah, Charles, Kota, Vamsi, Lipton, Jeffrey H et al (show 9 more authors)
(2022)
Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial.
, England.
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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<sup>4</sup> (58.2% vs. 48.1%; 1.50 [1.07-2.12]) and MR<sup>4.5</sup> (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.
| Item Type: | Conference or Workshop Item (Unspecified) |
|---|---|
| Uncontrolled Keywords: | BFORE study investigators, Humans, Leukemia, Myeloid, Chronic-Phase, Aniline Compounds, Nitriles, Quinolines, Antineoplastic Agents, Protein Kinase Inhibitors, Treatment Outcome, Imatinib Mesylate |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 17 Oct 2022 16:00 |
| Last Modified: | 18 Jan 2023 20:36 |
| DOI: | 10.1038/s41375-022-01589-y |
| Open Access URL: | https://www.nature.com/articles/s41375-022-01589-y |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3165566 |
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