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Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

Title
Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Authors
Kwak, Jae-YongKim, Sung-HyunOh, Suk JoongZang, Dae YoungKim, HawkKim, Jeong-ADo, Young RokKim, Hyeoung JoonPark, Joon SeongChoi, Chul WonLee, Won SikMun, Yeung-ChulKong, Jee HyunChung, Joo SeopShin, Ho-JinKim, Dae-YoungPark, JinnyJung, Chul WonBunworasate, UdomsakComia, Narcisa SoniaJootar, SaengsureeReksodiputro, Arry HarryantoCaguioa, Priscilla B.Lee, Sung-EunKim, Dong-Wook
Ewha Authors
문영철
SCOPUS Author ID
문영철scopus
Issue Date
2017
Journal Title
CLINICAL CANCER RESEARCH
ISSN
1078-0432JCR Link1557-3265JCR Link
Citation
vol. 23, no. 23, pp. 7180 - 7188
Publisher
AMER ASSOC CANCER RESEARCH
Indexed
SCI; SCIE; SCOPUS WOS
Abstract
Purpose: Radotinib is a second-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) approved in Korea for chronic phase chronic myeloid leukemia (CML-CP) in patients newly diagnosed or with insufficient response to other TKIs. This study was conducted to evaluate the efficacy and safety of radotinib as first-line therapy for CML-CP. Experimental Design: This multinational, open-label study assigned patients (1: 1: 1) to one of two twice-daily radotinib doses, or imatinib daily. The primary endpoint was major molecular response (MMR) by 12 months. Results: Two hundred forty-one patients were randomized to receive radotinib 300 mg (n = 79) or 400 mg twice-daily (n = 81), or imatinib 400 mg daily (n = 81). MMR rates by 12 months were higher in patients receiving radotinib 300 mg (52%) or radotinib 400 mg twice-daily (46%) versus imatinib (30%; P = 0.0044 and P = 0.0342, respectively). Complete cytogenetic response (CCyR) rates by 12 months were higher for radotinib 300 mg (91%) versus imatinib (77%; P = 0.0120). Early molecular response at 3 months occurred in 86% and 87% of patients receiving radotinib 300 mg and radotinib 400 mg, respectively, and 71% of those receiving imatinib. By 12 months, no patients had progression to accelerated phase or blast crisis. Most adverse events were manageable with dose reduction. Conclusions: Radotinib demonstrated superiority over imatinib in CCyR and MMR in patients newly diagnosed with Philadelphia chromosome-positive CML-CP. (C) 2017 AACR.
DOI
10.1158/1078-0432.CCR-17-0957
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의과대학 > 의학과 > Journal papers
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