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

Authors
Youngil KohInho KimSung-Soo YoonByoung Kook KimDae-Young KimJe-Hwan LeeKyoo-Hyung LeeEunkyung ParkHyeoung-Joon KimSang Kyun SohnYoung Don JooSeok Jin KimJooseop ChungHo-Jin ShinSung-Hyun KimChul Soo KimHong Suk SongMin Kyoung KimMyung Soo HyunJin Seok AhnChul Won JungSeonyang Park
Department
Dept. of Internal Medicine (내과학)
Issue Date
2010
Citation
Annals of Hematology, Vol.89(7) : 725-731, 2010
ISSN
0939-5555
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://kumel.medlib.dsmc.or.kr/handle/2015.oak/35005
Appears in Collections:
1. Journal Papers (연구논문) > 1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
Keimyung Author(s)
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Full Text
https://link.springer.com/article/10.1007%2Fs00277-010-0910-8
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