Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: Results from the 24-month follow-up of the BELA trial

Tim H. Brümmendorf, Jorge E. Cortes, Cármino Antonio de Souza, Francois Guilhot, Ladan Duvillié, Dmitri Pavlov, Karïn Gogat, Athena M. Countouriotis, Carlo Gambacorti-Passerini

Research output: Contribution to journalArticle

Abstract

Bosutinib is an oral, dual SRC/ABL1 tyrosine kinase inhibitor for resistant/intolerant chronic myeloid leukaemia (CML). We assessed the efficacy and safety of bosutinib 500 mg/d (n = 250) versus imatinib 400 mg/d (n = 252) after >24 months from accrual completion in newly diagnosed chronic phase (CP)-CML (Bosutinib Efficacy and Safety in Newly Diagnosed CML trial [BELA]). Cumulative complete cytogenetic response (CCyR) rates by 24 months were similar (bosutinib, 79%; imatinib, 80%); cumulative major molecular response (MMR) rates were 59% for bosutinib and 49% for imatinib. Responses were durable; 151/197 vs. 172/204 and 125/153 vs. 117/131 responders remained on treatment and maintained CCyR and MMR, respectively. Since the 12-month primary analysis, no new accelerated-/blast-phase transformations occurred with bosutinib; four occurred with imatinib. Early response (BCR-ABL1/ABL1 ≤ 10%, 3 months) was associated with better CCyR and MMR rates by 12 and 24 months (both arms). Gastrointestinal events and liver function test elevations were more common, and neutropenia, musculoskeletal events and oedema were less common with bosutinib. Discontinuations due to adverse events were more common with bosutinib versus imatinib (most commonly alanine aminotransferase elevation: 4% vs. <1%); most occurred within the first 12 months. Cardiovascular adverse events were similar in both arms. Bosutinib continues to demonstrate good efficacy and manageable tolerability in newly diagnosed CP-CML patients.

Original languageEnglish (US)
Pages (from-to)69-81
Number of pages13
JournalBritish Journal of Haematology
Volume168
Issue number1
DOIs
StatePublished - Jan 1 2015
Externally publishedYes

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Leukemia, Myeloid, Chronic Phase
Cytogenetics
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Safety
Imatinib Mesylate
bosutinib
Liver Function Tests
Lymphocyte Activation
Neutropenia
Alanine Transaminase
Protein-Tyrosine Kinases
Edema

Keywords

  • BCR-ABL1
  • Bosutinib
  • Chronic myeloid leukaemia
  • CML
  • Tyrosine kinase inhibitor

ASJC Scopus subject areas

  • Hematology

Cite this

Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia : Results from the 24-month follow-up of the BELA trial. / Brümmendorf, Tim H.; Cortes, Jorge E.; de Souza, Cármino Antonio; Guilhot, Francois; Duvillié, Ladan; Pavlov, Dmitri; Gogat, Karïn; Countouriotis, Athena M.; Gambacorti-Passerini, Carlo.

In: British Journal of Haematology, Vol. 168, No. 1, 01.01.2015, p. 69-81.

Research output: Contribution to journalArticle

Brümmendorf, TH, Cortes, JE, de Souza, CA, Guilhot, F, Duvillié, L, Pavlov, D, Gogat, K, Countouriotis, AM & Gambacorti-Passerini, C 2015, 'Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: Results from the 24-month follow-up of the BELA trial', British Journal of Haematology, vol. 168, no. 1, pp. 69-81. https://doi.org/10.1111/bjh.13108
Brümmendorf, Tim H. ; Cortes, Jorge E. ; de Souza, Cármino Antonio ; Guilhot, Francois ; Duvillié, Ladan ; Pavlov, Dmitri ; Gogat, Karïn ; Countouriotis, Athena M. ; Gambacorti-Passerini, Carlo. / Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia : Results from the 24-month follow-up of the BELA trial. In: British Journal of Haematology. 2015 ; Vol. 168, No. 1. pp. 69-81.
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