Phase IV study evaluating efficacy of escalated dose of imatinib in chronic myeloid leukemia patients showing suboptimal response to standard dose imatinib

Title
Phase IV study evaluating efficacy of escalated dose of imatinib in chronic myeloid leukemia patients showing suboptimal response to standard dose imatinib
Author(s)
김민경고영길[고영길]김인호[김인호]윤성수[윤성수]김병국[김병국]김대영[김대영]이제황[이제황]이규형[이규형]박은경[박은경]김형준[김형준]손상건[손상건]주영돈[주영돈]김석진[김석진]정주섭[정주섭]신호진[신호진]김성현[김성현]송홍석[송홍석]현명수안진석[안진석]정철원[정철원]박선양[박선양]
Keywords
CHRONIC MYELOGENOUS LEUKEMIA; BCR-ABL; EUROPEAN-LEUKEMIANET; MOLECULAR RESPONSES; RANDOMIZED PHASE-2; FOLLOW-UP; RESISTANCE; MESYLATE; DASATINIB; MECHANISMS
Issue Date
201007
Publisher
SPRINGER
Citation
ANNALS OF HEMATOLOGY, v.89, no.7, pp.725 - 731
Abstract
The aim of this phase IV study was to (1) to define efficacy of escalating dose imatinib in chronic myeloid leukemia (CML) patients showing suboptimal response to standard dose imatinib and (2) to find markers that predict the response to escalating doses of imatinib. CML patients in chronic phase (CP) who failed to achieve optimal response with 400 mg/day imatinib or patients in accelerated phase (AP) or blast crisis (BC) who failed to achieve complete hematologic response after 3 months of 400-600 mg/day imatinib were enrolled. CP patients received 600 mg/day, while AP/BC patients received 600-800 mg/day imatinib. Patients received imatinib for at least 12 months or until the disease progression or intolerable toxicity. Along with cytogenetic response (CyR), molecular response was assessed with BCR-ABL/ABL ratio. Baseline BCR-ABL gene mutation test was performed. Seventy-one patients (median age, 49.0 years, M:F = 50:21) received escalated dose imatinib. Grade 3 edema in two patients was the only nonhematologic toxicities more than grade 2. For evaluable patients, 30.8% of patients achieved CCyR at 6 months, and median time to treatment failure (TTFx) was 18.0 months. TTFx was longer in patients who achieved greater than 50% reduction in BCR-ABL/ABL within 6 months (early molecular responder (EMR)) compared with those who did not (non-EMR; p < 0.001). Of 31 patients who had mutational status data, three had mutation. All mutants failed to achieve CCyR. In conclusion, escalated dose imatinib shows considerable efficacy with tolerable toxicity in CML patients showing suboptimal response to standard dose imatinib. EMR is an early predictive marker for positive imatinib response.
URI
http://hdl.handle.net/YU.REPOSITORY/22191http://dx.doi.org/10.1007/s00277-010-0910-8
ISSN
0939-5555
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의과대학 > 내과학교실 > Articles
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