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Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib

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Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib. / Brümmendorf, Tim H; Cortes, Jorge E; Khoury, Hanna J; Kantarjian, Hagop M; Kim, Dong-Wook; Schafhausen, Philippe; Conlan, Maureen G; Shapiro, Mark; Turnbull, Kathleen; Leip, Eric; Gambacorti-Passerini, Carlo; Lipton, Jeff H.

in: BRIT J HAEMATOL, Jahrgang 172, Nr. 1, 01.2016, S. 97-110.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Brümmendorf, TH, Cortes, JE, Khoury, HJ, Kantarjian, HM, Kim, D-W, Schafhausen, P, Conlan, MG, Shapiro, M, Turnbull, K, Leip, E, Gambacorti-Passerini, C & Lipton, JH 2016, 'Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib', BRIT J HAEMATOL, Jg. 172, Nr. 1, S. 97-110. https://doi.org/10.1111/bjh.13801

APA

Brümmendorf, T. H., Cortes, J. E., Khoury, H. J., Kantarjian, H. M., Kim, D-W., Schafhausen, P., Conlan, M. G., Shapiro, M., Turnbull, K., Leip, E., Gambacorti-Passerini, C., & Lipton, J. H. (2016). Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib. BRIT J HAEMATOL, 172(1), 97-110. https://doi.org/10.1111/bjh.13801

Vancouver

Brümmendorf TH, Cortes JE, Khoury HJ, Kantarjian HM, Kim D-W, Schafhausen P et al. Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib. BRIT J HAEMATOL. 2016 Jan;172(1):97-110. https://doi.org/10.1111/bjh.13801

Bibtex

@article{6f5e27850b1448f9b9ff7185bf0a78a8,
title = "Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib",
abstract = "The dual SRC/ABL1 tyrosine kinase inhibitor bosutinib is indicated for adults with Ph+ chronic myeloid leukaemia (CML) resistant/intolerant to prior therapy. This analysis of an ongoing phase 1/2 study (NCT00261846) assessed effects of baseline patient characteristics on long-term efficacy and safety of bosutinib 500 mg/day in adults with imatinib (IM)-resistant (IM-R; n = 196)/IM-intolerant (IM-I; n = 90) chronic phase (CP) CML. Median treatment duration was 24·8 months (median follow-up, 43·6 months). Cumulative major cytogenetic response (MCyR) rate [95% confidence interval (CI)], was 59% (53-65%); Kaplan-Meier (KM) probability of maintaining MCyR at 4 years was 75% (66-81%). Cumulative incidence of on-treatment progression/death at 4 years was 19% (95% CI, 15-24%); KM 2-year overall survival was 91% (87-94%). Significant baseline predictors of both MCyR and complete cytogenetic response (newly attained/maintained from baseline) at 3 and 6 months included prior IM cytogenetic response, baseline MCyR, prior interferon therapy and <6 months duration from diagnosis to IM treatment initiation and no interferon treatment before IM. The most common adverse event (AE) was diarrhoea (86%). Baseline bosutinib-sensitive BCR-ABL1 mutation was the only significant predictor of grade 3/4 diarrhoea; no significant predictors were identified for liver-related AEs. Bosutinib demonstrates durable efficacy and manageable toxicity in IM-R/IM-I CP-CML patients.",
author = "Br{\"u}mmendorf, {Tim H} and Cortes, {Jorge E} and Khoury, {Hanna J} and Kantarjian, {Hagop M} and Dong-Wook Kim and Philippe Schafhausen and Conlan, {Maureen G} and Mark Shapiro and Kathleen Turnbull and Eric Leip and Carlo Gambacorti-Passerini and Lipton, {Jeff H}",
note = "{\textcopyright} 2015 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.",
year = "2016",
month = jan,
doi = "10.1111/bjh.13801",
language = "English",
volume = "172",
pages = "97--110",
journal = "BRIT J HAEMATOL",
issn = "0007-1048",
publisher = "Wiley-Blackwell",
number = "1",

}

RIS

TY - JOUR

T1 - Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib

AU - Brümmendorf, Tim H

AU - Cortes, Jorge E

AU - Khoury, Hanna J

AU - Kantarjian, Hagop M

AU - Kim, Dong-Wook

AU - Schafhausen, Philippe

AU - Conlan, Maureen G

AU - Shapiro, Mark

AU - Turnbull, Kathleen

AU - Leip, Eric

AU - Gambacorti-Passerini, Carlo

AU - Lipton, Jeff H

N1 - © 2015 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

PY - 2016/1

Y1 - 2016/1

N2 - The dual SRC/ABL1 tyrosine kinase inhibitor bosutinib is indicated for adults with Ph+ chronic myeloid leukaemia (CML) resistant/intolerant to prior therapy. This analysis of an ongoing phase 1/2 study (NCT00261846) assessed effects of baseline patient characteristics on long-term efficacy and safety of bosutinib 500 mg/day in adults with imatinib (IM)-resistant (IM-R; n = 196)/IM-intolerant (IM-I; n = 90) chronic phase (CP) CML. Median treatment duration was 24·8 months (median follow-up, 43·6 months). Cumulative major cytogenetic response (MCyR) rate [95% confidence interval (CI)], was 59% (53-65%); Kaplan-Meier (KM) probability of maintaining MCyR at 4 years was 75% (66-81%). Cumulative incidence of on-treatment progression/death at 4 years was 19% (95% CI, 15-24%); KM 2-year overall survival was 91% (87-94%). Significant baseline predictors of both MCyR and complete cytogenetic response (newly attained/maintained from baseline) at 3 and 6 months included prior IM cytogenetic response, baseline MCyR, prior interferon therapy and <6 months duration from diagnosis to IM treatment initiation and no interferon treatment before IM. The most common adverse event (AE) was diarrhoea (86%). Baseline bosutinib-sensitive BCR-ABL1 mutation was the only significant predictor of grade 3/4 diarrhoea; no significant predictors were identified for liver-related AEs. Bosutinib demonstrates durable efficacy and manageable toxicity in IM-R/IM-I CP-CML patients.

AB - The dual SRC/ABL1 tyrosine kinase inhibitor bosutinib is indicated for adults with Ph+ chronic myeloid leukaemia (CML) resistant/intolerant to prior therapy. This analysis of an ongoing phase 1/2 study (NCT00261846) assessed effects of baseline patient characteristics on long-term efficacy and safety of bosutinib 500 mg/day in adults with imatinib (IM)-resistant (IM-R; n = 196)/IM-intolerant (IM-I; n = 90) chronic phase (CP) CML. Median treatment duration was 24·8 months (median follow-up, 43·6 months). Cumulative major cytogenetic response (MCyR) rate [95% confidence interval (CI)], was 59% (53-65%); Kaplan-Meier (KM) probability of maintaining MCyR at 4 years was 75% (66-81%). Cumulative incidence of on-treatment progression/death at 4 years was 19% (95% CI, 15-24%); KM 2-year overall survival was 91% (87-94%). Significant baseline predictors of both MCyR and complete cytogenetic response (newly attained/maintained from baseline) at 3 and 6 months included prior IM cytogenetic response, baseline MCyR, prior interferon therapy and <6 months duration from diagnosis to IM treatment initiation and no interferon treatment before IM. The most common adverse event (AE) was diarrhoea (86%). Baseline bosutinib-sensitive BCR-ABL1 mutation was the only significant predictor of grade 3/4 diarrhoea; no significant predictors were identified for liver-related AEs. Bosutinib demonstrates durable efficacy and manageable toxicity in IM-R/IM-I CP-CML patients.

U2 - 10.1111/bjh.13801

DO - 10.1111/bjh.13801

M3 - SCORING: Journal article

C2 - 26537529

VL - 172

SP - 97

EP - 110

JO - BRIT J HAEMATOL

JF - BRIT J HAEMATOL

SN - 0007-1048

IS - 1

ER -