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Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia

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Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. / Gambacorti-Passerini, Carlo; Cortes, Jorge E; Lipton, Jeff H; Dmoszynska, Anna; Wong, Raymond S; Rossiev, Victor; Pavlov, Dmitri; Gogat Marchant, Karin; Duvillié, Ladan; Khattry, Navin; Kantarjian, Hagop M; Brümmendorf, Tim H.

In: AM J HEMATOL, Vol. 89, No. 10, 2014, p. 947-53.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Gambacorti-Passerini, C, Cortes, JE, Lipton, JH, Dmoszynska, A, Wong, RS, Rossiev, V, Pavlov, D, Gogat Marchant, K, Duvillié, L, Khattry, N, Kantarjian, HM & Brümmendorf, TH 2014, 'Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia', AM J HEMATOL, vol. 89, no. 10, pp. 947-53. https://doi.org/10.1002/ajh.23788

APA

Gambacorti-Passerini, C., Cortes, J. E., Lipton, J. H., Dmoszynska, A., Wong, R. S., Rossiev, V., Pavlov, D., Gogat Marchant, K., Duvillié, L., Khattry, N., Kantarjian, H. M., & Brümmendorf, T. H. (2014). Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. AM J HEMATOL, 89(10), 947-53. https://doi.org/10.1002/ajh.23788

Vancouver

Gambacorti-Passerini C, Cortes JE, Lipton JH, Dmoszynska A, Wong RS, Rossiev V et al. Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. AM J HEMATOL. 2014;89(10):947-53. https://doi.org/10.1002/ajh.23788

Bibtex

@article{0eeb38dcf14d4f9dabafd69f769faed5,
title = "Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia",
abstract = "Bosutinib, an orally active, Src/Abl tyrosine kinase inhibitor, has demonstrated clinical activity and acceptable tolerability in chronic phase chronic myeloid leukemia (CP CML). This updated analysis of the BELA trial assessed the safety profile and management of toxicities of bosutinib versus imatinib in adults with newly diagnosed (≤6 months) CP CML after >30 months from accrual completion. Among patients randomized to bosutinib 500 mg/d (n = 250) or imatinib 400 mg/d (n = 252), 248 and 251, respectively, received ≥1 dose of study treatment. Adverse events (AEs; any grade) with bosutinib versus imatinib were significantly more common for certain gastrointestinal events (diarrhea, 70% vs. 26%; P < 0.001; vomiting, 33% vs. 16%; P < 0.001), alanine aminotransferase (33% vs. 9%; P < 0.001) and aspartate aminotransferase (28% vs. 10%; P < 0.001) elevations, and pyrexia (19% vs. 12%; P = 0.046). AEs significantly less common with bosutinib included edema (periorbital, 2% vs. 14%; P < 0.001; peripheral, 5% vs. 12%; P = 0.006), musculoskeletal (myalgia, 5% vs. 12%; P = 0.010; muscle cramps, 5% vs. 22%; P < 0.001; bone pain, 4% vs. 11%; P = 0.003), increased creatine phosphokinase (8% vs. 20%; P < 0.001), neutropenia (13% vs. 30%; P < 0.001), and leukopenia (9% vs. 22%; P < 0.001). Between-group differences in the incidence of cardiac and vascular AEs were not significant. Diarrhea was typically transient, mostly Grade 1/2, occurring early during treatment, and was manageable with antidiarrheal medication. Despite higher rates of aminotransferase elevation with bosutinib, events were managed in most patients with dose modification and/or concomitant medication. Bosutinib had a manageable safety profile distinct from that of imatinib in patients with newly diagnosed CP CML.",
keywords = "Alanine Transaminase, Aniline Compounds, Antineoplastic Agents, Aspartate Aminotransferases, Benzamides, Diarrhea, Female, Fever, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Male, Middle Aged, Muscle Cramp, Myalgia, Nitriles, Pain, Piperazines, Pyrimidines, Quinolines, Vomiting",
author = "Carlo Gambacorti-Passerini and Cortes, {Jorge E} and Lipton, {Jeff H} and Anna Dmoszynska and Wong, {Raymond S} and Victor Rossiev and Dmitri Pavlov and {Gogat Marchant}, Karin and Ladan Duvilli{\'e} and Navin Khattry and Kantarjian, {Hagop M} and Br{\"u}mmendorf, {Tim H}",
note = "{\textcopyright} 2014 The Authors. American Journal of Hematology Published by Wiley Periodicals, Inc.",
year = "2014",
doi = "10.1002/ajh.23788",
language = "English",
volume = "89",
pages = "947--53",
journal = "AM J HEMATOL",
issn = "0361-8609",
publisher = "Wiley-Liss Inc.",
number = "10",

}

RIS

TY - JOUR

T1 - Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia

AU - Gambacorti-Passerini, Carlo

AU - Cortes, Jorge E

AU - Lipton, Jeff H

AU - Dmoszynska, Anna

AU - Wong, Raymond S

AU - Rossiev, Victor

AU - Pavlov, Dmitri

AU - Gogat Marchant, Karin

AU - Duvillié, Ladan

AU - Khattry, Navin

AU - Kantarjian, Hagop M

AU - Brümmendorf, Tim H

N1 - © 2014 The Authors. American Journal of Hematology Published by Wiley Periodicals, Inc.

PY - 2014

Y1 - 2014

N2 - Bosutinib, an orally active, Src/Abl tyrosine kinase inhibitor, has demonstrated clinical activity and acceptable tolerability in chronic phase chronic myeloid leukemia (CP CML). This updated analysis of the BELA trial assessed the safety profile and management of toxicities of bosutinib versus imatinib in adults with newly diagnosed (≤6 months) CP CML after >30 months from accrual completion. Among patients randomized to bosutinib 500 mg/d (n = 250) or imatinib 400 mg/d (n = 252), 248 and 251, respectively, received ≥1 dose of study treatment. Adverse events (AEs; any grade) with bosutinib versus imatinib were significantly more common for certain gastrointestinal events (diarrhea, 70% vs. 26%; P < 0.001; vomiting, 33% vs. 16%; P < 0.001), alanine aminotransferase (33% vs. 9%; P < 0.001) and aspartate aminotransferase (28% vs. 10%; P < 0.001) elevations, and pyrexia (19% vs. 12%; P = 0.046). AEs significantly less common with bosutinib included edema (periorbital, 2% vs. 14%; P < 0.001; peripheral, 5% vs. 12%; P = 0.006), musculoskeletal (myalgia, 5% vs. 12%; P = 0.010; muscle cramps, 5% vs. 22%; P < 0.001; bone pain, 4% vs. 11%; P = 0.003), increased creatine phosphokinase (8% vs. 20%; P < 0.001), neutropenia (13% vs. 30%; P < 0.001), and leukopenia (9% vs. 22%; P < 0.001). Between-group differences in the incidence of cardiac and vascular AEs were not significant. Diarrhea was typically transient, mostly Grade 1/2, occurring early during treatment, and was manageable with antidiarrheal medication. Despite higher rates of aminotransferase elevation with bosutinib, events were managed in most patients with dose modification and/or concomitant medication. Bosutinib had a manageable safety profile distinct from that of imatinib in patients with newly diagnosed CP CML.

AB - Bosutinib, an orally active, Src/Abl tyrosine kinase inhibitor, has demonstrated clinical activity and acceptable tolerability in chronic phase chronic myeloid leukemia (CP CML). This updated analysis of the BELA trial assessed the safety profile and management of toxicities of bosutinib versus imatinib in adults with newly diagnosed (≤6 months) CP CML after >30 months from accrual completion. Among patients randomized to bosutinib 500 mg/d (n = 250) or imatinib 400 mg/d (n = 252), 248 and 251, respectively, received ≥1 dose of study treatment. Adverse events (AEs; any grade) with bosutinib versus imatinib were significantly more common for certain gastrointestinal events (diarrhea, 70% vs. 26%; P < 0.001; vomiting, 33% vs. 16%; P < 0.001), alanine aminotransferase (33% vs. 9%; P < 0.001) and aspartate aminotransferase (28% vs. 10%; P < 0.001) elevations, and pyrexia (19% vs. 12%; P = 0.046). AEs significantly less common with bosutinib included edema (periorbital, 2% vs. 14%; P < 0.001; peripheral, 5% vs. 12%; P = 0.006), musculoskeletal (myalgia, 5% vs. 12%; P = 0.010; muscle cramps, 5% vs. 22%; P < 0.001; bone pain, 4% vs. 11%; P = 0.003), increased creatine phosphokinase (8% vs. 20%; P < 0.001), neutropenia (13% vs. 30%; P < 0.001), and leukopenia (9% vs. 22%; P < 0.001). Between-group differences in the incidence of cardiac and vascular AEs were not significant. Diarrhea was typically transient, mostly Grade 1/2, occurring early during treatment, and was manageable with antidiarrheal medication. Despite higher rates of aminotransferase elevation with bosutinib, events were managed in most patients with dose modification and/or concomitant medication. Bosutinib had a manageable safety profile distinct from that of imatinib in patients with newly diagnosed CP CML.

KW - Alanine Transaminase

KW - Aniline Compounds

KW - Antineoplastic Agents

KW - Aspartate Aminotransferases

KW - Benzamides

KW - Diarrhea

KW - Female

KW - Fever

KW - Humans

KW - Leukemia, Myelogenous, Chronic, BCR-ABL Positive

KW - Male

KW - Middle Aged

KW - Muscle Cramp

KW - Myalgia

KW - Nitriles

KW - Pain

KW - Piperazines

KW - Pyrimidines

KW - Quinolines

KW - Vomiting

U2 - 10.1002/ajh.23788

DO - 10.1002/ajh.23788

M3 - SCORING: Journal article

C2 - 24944159

VL - 89

SP - 947

EP - 953

JO - AM J HEMATOL

JF - AM J HEMATOL

SN - 0361-8609

IS - 10

ER -