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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

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
Issue Date
1-12월-2017
Publisher
AMER ASSOC CANCER RESEARCH
Citation
CLINICAL CANCER RESEARCH, v.23, no.23, pp.7180 - 7188
Indexed
SCIE
SCOPUS
Journal Title
CLINICAL CANCER RESEARCH
Volume
23
Number
23
Start Page
7180
End Page
7188
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/81223
DOI
10.1158/1078-0432.CCR-17-0957
ISSN
1078-0432
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.
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