Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial

被引：74

作者：

Brummendorf, Tim H. ^{[1
]}

Cortes, Jorge E. ^{[2
]}

Milojkovic, Dragana ^{[3
]}

Gambacorti-Passerini, Carlo ^{[4
]}

Clark, Richard E. ^{[5
]}

le Coutre, Philipp ^{[6
]}

Garcia-Gutierrez, Valentin ^{[7
]}

Chuah, Charles ^{[8
]}

Kota, Vamsi ^{[2
]}

Lipton, Jeffrey H. ^{[9
]}

Rousselot, Philippe ^{[10
]}

Mauro, Michael J. ^{[11
]}

Hochhaus, Andreas ^{[12
]}

Hurtado Monroy, Rafael ^{[13
]}

Leip, Eric ^{[14
]}

Purcell, Simon ^{[15
]}

Yver, Anne ^{[16
]}

Viqueira, Andrea ^{[17
]}

Deininger, Michael W. ^{[18
]}

机构：

[1] Univ Klinikum RWTH Aachen, Aachen, Germany

[2] Georgia Canc Ctr, Augusta, GA USA

[3] Hammersmith Hosp, London, England

[4] Univ Milano Bicocca, Monza, Italy

[5] Univ Liverpool, Dept Mol & Clin Canc Med, Liverpool, Merseyside, England

[6] Charite Univ Med Berlin, Berlin, Germany

[7] Hosp Univ Ramon y Cajal, Ramon y Cajal Hlth Res Inst, Madrid, Spain

[8] Singapore Gen Hosp, Duke NUS Med Sch, Singapore, Singapore

[9] Princess Margaret Canc Ctr, Toronto, ON, Canada

[10] Ctr Hosp Versailles, Le Chesnay, France

[11] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA

[12] Univ Klinikum Jena, Klin Innere Med 2, Jena, Germany

[13] Hosp Angeles Pedregal, Mexico City, DF, Mexico

[14] Pfizer Inc, Cambridge, MA USA

[15] Pfizer Ltd, London, England

[16] Pfizer Inc, Paris, France

[17] Pfizer SLU, Madrid, Spain

[18] Univ Utah Hlth Care, Salt Lake City, UT USA

来源：

LEUKEMIA | 2022年 / 36卷 / 07期

关键词：

MOLECULAR RESPONSE; DASATINIB; INTOLERANT; RESISTANT; BCR-ABL1; EFFICACY; SAFETY;

D O I：

10.1038/s41375-022-01589-y

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. Treatmentemergent 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.

引用

页码：1825 / 1833

页数：9

共 30 条

[1] Why is it critical to achieve a deep molecular response in chronic myeloid leukemia? [J].