Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia:results from the 24-month follow-up of the BELA trial
Standard
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: BRIT J HAEMATOL, Jahrgang 168, Nr. 1, 2015, S. 69-81.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia:results from the 24-month follow-up of the BELA trial
AU - Brümmendorf, Tim H
AU - Cortes, Jorge E
AU - de Souza, Cármino Antonio
AU - Guilhot, Francois
AU - Duvillié, Ladan
AU - Pavlov, Dmitri
AU - Gogat, Karïn
AU - Countouriotis, Athena M
AU - Gambacorti-Passerini, Carlo
N1 - © 2014 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.
PY - 2015
Y1 - 2015
N2 - 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.
AB - 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.
KW - Aged
KW - Aged, 80 and over
KW - Aniline Compounds
KW - Antineoplastic Agents
KW - Benzamides
KW - Female
KW - Follow-Up Studies
KW - Fusion Proteins, bcr-abl
KW - Humans
KW - Leukemia, Myeloid, Chronic-Phase
KW - Male
KW - Middle Aged
KW - Mutation
KW - Nitriles
KW - Odds Ratio
KW - Piperazines
KW - Protein Kinase Inhibitors
KW - Pyrimidines
KW - Quinolines
KW - Treatment Outcome
U2 - 10.1111/bjh.13108
DO - 10.1111/bjh.13108
M3 - SCORING: Journal article
C2 - 25196702
VL - 168
SP - 69
EP - 81
JO - BRIT J HAEMATOL
JF - BRIT J HAEMATOL
SN - 0007-1048
IS - 1
ER -