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Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up

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Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up. / Gambacorti-Passerini, Carlo; Brümmendorf, Tim H; Kim, Dong-Wook; Turkina, Anna G; Masszi, Tamas; Assouline, Sarit; Durrant, Simon; Kantarjian, Hagop M; Khoury, H Jean; Zaritskey, Andrey; Shen, Zhi-Xiang; Jin, Jie; Vellenga, Edo; Pasquini, Ricardo; Mathews, Vikram; Cervantes, Francisco; Besson, Nadine; Turnbull, Kathleen; Leip, Eric; Kelly, Virginia; Cortes, Jorge E.

In: AM J HEMATOL, Vol. 89, No. 7, 2014, p. 732-42.

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

Harvard

Gambacorti-Passerini, C, Brümmendorf, TH, Kim, D-W, Turkina, AG, Masszi, T, Assouline, S, Durrant, S, Kantarjian, HM, Khoury, HJ, Zaritskey, A, Shen, Z-X, Jin, J, Vellenga, E, Pasquini, R, Mathews, V, Cervantes, F, Besson, N, Turnbull, K, Leip, E, Kelly, V & Cortes, JE 2014, 'Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up', AM J HEMATOL, vol. 89, no. 7, pp. 732-42. https://doi.org/10.1002/ajh.23728

APA

Gambacorti-Passerini, C., Brümmendorf, T. H., Kim, D-W., Turkina, A. G., Masszi, T., Assouline, S., Durrant, S., Kantarjian, H. M., Khoury, H. J., Zaritskey, A., Shen, Z-X., Jin, J., Vellenga, E., Pasquini, R., Mathews, V., Cervantes, F., Besson, N., Turnbull, K., Leip, E., ... Cortes, J. E. (2014). Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up. AM J HEMATOL, 89(7), 732-42. https://doi.org/10.1002/ajh.23728

Vancouver

Gambacorti-Passerini C, Brümmendorf TH, Kim D-W, Turkina AG, Masszi T, Assouline S et al. Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up. AM J HEMATOL. 2014;89(7):732-42. https://doi.org/10.1002/ajh.23728

Bibtex

@article{f0675f84397543e4b62aba6f4f74eece,
title = "Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up",
abstract = "Bosutinib is an orally active, dual Src/Abl tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) following resistance/intolerance to prior therapy. Here, we report the data from the 2-year follow-up of a phase 1/2 open-label study evaluating the efficacy and safety of bosutinib as second-line therapy in 288 patients with chronic phase CML resistant (n = 200) or intolerant (n = 88) to imatinib. The cumulative response rates to bosutinib were as follows: 85% achieved/maintained complete hematologic response, 59% achieved/maintained major cytogenetic response (including 48% with complete cytogenetic response), and 35% achieved major molecular response. Responses were durable, with 2-year estimates of retaining response >70%. Two-year probabilities of progression-free survival and overall survival were 81% and 91%, respectively. The most common toxicities were primarily gastrointestinal adverse events (diarrhea [84%], nausea [45%], vomiting [37%]), which were primarily mild to moderate, typically transient, and first occurred early during treatment. Thrombocytopenia was the most common grade 3/4 hematologic laboratory abnormality (24%). Outcomes were generally similar among imatinib-resistant and imatinib-intolerant patients and did not differ with age. The longer-term results of the present analysis confirm that bosutinib is an effective and tolerable second-line therapy for patients with imatinib-resistant or imatinib-intolerant chronic phase CML. ClinicalTrials.gov Identifier: NCT00261846.",
keywords = "Adolescent, Adult, Aged, Aged, 80 and over, Aniline Compounds, Antineoplastic Agents, Benzamides, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Resistance, Neoplasm, Female, Follow-Up Studies, Humans, Leukemia, Myeloid, Chronic-Phase, Male, Middle Aged, Nitriles, Piperazines, Protein Kinase Inhibitors, Pyrimidines, Quinolines, Treatment Outcome, Young Adult",
author = "Carlo Gambacorti-Passerini and Br{\"u}mmendorf, {Tim H} and Dong-Wook Kim and Turkina, {Anna G} and Tamas Masszi and Sarit Assouline and Simon Durrant and Kantarjian, {Hagop M} and Khoury, {H Jean} and Andrey Zaritskey and Zhi-Xiang Shen and Jie Jin and Edo Vellenga and Ricardo Pasquini and Vikram Mathews and Francisco Cervantes and Nadine Besson and Kathleen Turnbull and Eric Leip and Virginia Kelly and Cortes, {Jorge E}",
note = "{\textcopyright} 2014 The Authors American Journal of Hematology Published by Wiley Periodicals, Inc.",
year = "2014",
doi = "10.1002/ajh.23728",
language = "English",
volume = "89",
pages = "732--42",
journal = "AM J HEMATOL",
issn = "0361-8609",
publisher = "Wiley-Liss Inc.",
number = "7",

}

RIS

TY - JOUR

T1 - Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up

AU - Gambacorti-Passerini, Carlo

AU - Brümmendorf, Tim H

AU - Kim, Dong-Wook

AU - Turkina, Anna G

AU - Masszi, Tamas

AU - Assouline, Sarit

AU - Durrant, Simon

AU - Kantarjian, Hagop M

AU - Khoury, H Jean

AU - Zaritskey, Andrey

AU - Shen, Zhi-Xiang

AU - Jin, Jie

AU - Vellenga, Edo

AU - Pasquini, Ricardo

AU - Mathews, Vikram

AU - Cervantes, Francisco

AU - Besson, Nadine

AU - Turnbull, Kathleen

AU - Leip, Eric

AU - Kelly, Virginia

AU - Cortes, Jorge E

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

PY - 2014

Y1 - 2014

N2 - Bosutinib is an orally active, dual Src/Abl tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) following resistance/intolerance to prior therapy. Here, we report the data from the 2-year follow-up of a phase 1/2 open-label study evaluating the efficacy and safety of bosutinib as second-line therapy in 288 patients with chronic phase CML resistant (n = 200) or intolerant (n = 88) to imatinib. The cumulative response rates to bosutinib were as follows: 85% achieved/maintained complete hematologic response, 59% achieved/maintained major cytogenetic response (including 48% with complete cytogenetic response), and 35% achieved major molecular response. Responses were durable, with 2-year estimates of retaining response >70%. Two-year probabilities of progression-free survival and overall survival were 81% and 91%, respectively. The most common toxicities were primarily gastrointestinal adverse events (diarrhea [84%], nausea [45%], vomiting [37%]), which were primarily mild to moderate, typically transient, and first occurred early during treatment. Thrombocytopenia was the most common grade 3/4 hematologic laboratory abnormality (24%). Outcomes were generally similar among imatinib-resistant and imatinib-intolerant patients and did not differ with age. The longer-term results of the present analysis confirm that bosutinib is an effective and tolerable second-line therapy for patients with imatinib-resistant or imatinib-intolerant chronic phase CML. ClinicalTrials.gov Identifier: NCT00261846.

AB - Bosutinib is an orally active, dual Src/Abl tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) following resistance/intolerance to prior therapy. Here, we report the data from the 2-year follow-up of a phase 1/2 open-label study evaluating the efficacy and safety of bosutinib as second-line therapy in 288 patients with chronic phase CML resistant (n = 200) or intolerant (n = 88) to imatinib. The cumulative response rates to bosutinib were as follows: 85% achieved/maintained complete hematologic response, 59% achieved/maintained major cytogenetic response (including 48% with complete cytogenetic response), and 35% achieved major molecular response. Responses were durable, with 2-year estimates of retaining response >70%. Two-year probabilities of progression-free survival and overall survival were 81% and 91%, respectively. The most common toxicities were primarily gastrointestinal adverse events (diarrhea [84%], nausea [45%], vomiting [37%]), which were primarily mild to moderate, typically transient, and first occurred early during treatment. Thrombocytopenia was the most common grade 3/4 hematologic laboratory abnormality (24%). Outcomes were generally similar among imatinib-resistant and imatinib-intolerant patients and did not differ with age. The longer-term results of the present analysis confirm that bosutinib is an effective and tolerable second-line therapy for patients with imatinib-resistant or imatinib-intolerant chronic phase CML. ClinicalTrials.gov Identifier: NCT00261846.

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Aniline Compounds

KW - Antineoplastic Agents

KW - Benzamides

KW - Disease-Free Survival

KW - Dose-Response Relationship, Drug

KW - Drug Resistance, Neoplasm

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Leukemia, Myeloid, Chronic-Phase

KW - Male

KW - Middle Aged

KW - Nitriles

KW - Piperazines

KW - Protein Kinase Inhibitors

KW - Pyrimidines

KW - Quinolines

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1002/ajh.23728

DO - 10.1002/ajh.23728

M3 - SCORING: Journal article

C2 - 24711212

VL - 89

SP - 732

EP - 742

JO - AM J HEMATOL

JF - AM J HEMATOL

SN - 0361-8609

IS - 7

ER -