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, Jahrgang 89, Nr. 7, 2014, S. 732-42.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -