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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.

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Author(s)
Jae-Yong KwakSung-Hyun KimSuk Joong OhDae Young ZangHawk KimJeong-A KimYoung Rok DoHyeoung Joon KimJoon Seong ParkChulWon ChoiWon Sik LeeYeung-Chul MunJee Hyun KongJoo Seop ChungHo-Jin ShinDae-Young KimJinny ParkChul Won JungUdomsak BunworasateNarcisa Sonia ComiaSaengsuree JootarArry Harryanto ReksodiputroPriscilla B. CaguioaSung-Eun LeeDong-Wook Kim
Keimyung Author(s)
Do, Young Rok
Department
Dept. of Internal Medicine (내과학)
Journal Title
Clinical Cancer Research
Issued Date
2017
Volume
23
Issue
23
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. This trial was registered at www.clinicaltrials.gov as NCT01511289 Clin Cancer Res; 23(23); 7180-8. ©2017 AACR.
Keimyung Author(s)(Kor)
도영록
Publisher
School of Medicine (의과대학)
Citation
Jae-Yong Kwak et al. (2017). Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia. Clinical Cancer Research, 23(23), 7180–7188. doi: 10.1158/1078-0432.CCR-17-0957
Type
Article
ISSN
1078-0432
DOI
10.1158/1078-0432.CCR-17-0957
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41386
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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