Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: Final results from the BFORE trial Journal Article
| Authors: | Brümmendorf, T. H.; Cortes, J. E.; Milojkovic, D.; Gambacorti-Passerini, C.; Clark, R. E.; le Coutre, P.; Garcia-Gutierrez, V.; Chuah, C.; Kota, V.; Lipton, J. H.; Rousselot, P.; Mauro, M. J.; Hochhaus, A.; Hurtado Monroy, R.; Leip, E.; Purcell, S.; Yver, A.; Viqueira, A.; Deininger, M. W.; and BFORE study investigators |
| Article Title: | Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: Final results from the BFORE trial |
| 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 MR4 (58.2% vs. 48.1%; 1.50 [1.07–2.12]) and MR4.5 (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. © 2022, The Author(s). |
| Keywords: | adult; controlled study; treatment outcome; treatment response; aged; major clinical study; clinical trial; disease course; neutropenia; diarrhea; drug efficacy; drug safety; drug withdrawal; hypertension; side effect; treatment duration; antineoplastic agents; follow up; antineoplastic agent; imatinib; anemia; protein kinase inhibitor; leukopenia; nausea; randomized controlled trial; thrombocytopenia; vomiting; myalgia; incidence; qt prolongation; bone pain; chronic myeloid leukemia; high risk patient; arthralgia; backache; hyperglycemia; lymphocytopenia; pruritus; rash; protein kinase inhibitors; acute kidney failure; maculopapular rash; cerebrovascular disease; multicenter study; peripheral vascular disease; acne; fusion gene; peripheral edema; erythema; limb pain; eyelid edema; pleura effusion; hyperbilirubinemia; orbit edema; aniline compounds; hypercholesterolemia; periorbital edema; muscle spasm; pericardial effusion; nitriles; nitrile; heart muscle ischemia; sinus bradycardia; imatinib mesylate; myeloid leukemia; quinolines; face edema; quinoline derivative; musculoskeletal pain; hypertransaminasemia; angina pectoris; leukemia, myeloid, chronic-phase; bosutinib; aniline derivative; very elderly; eczema; humans; human; male; female; article; bcr abl1 gene; chronic phase chronic myeloid leukemia |
| Journal Title: | Leukemia |
| Volume: | 36 |
| Issue: | 7 |
| ISSN: | 0887-6924 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2022-07-01 |
| Start Page: | 1825 |
| End Page: | 1833 |
| Language: | English |
| DOI: | 10.1038/s41375-022-01589-y |
| PUBMED: | 35643868 |
| PROVIDER: | scopus |
| PMCID: | PMC9252917 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 August 2022 -- Source: Scopus |
