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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: Jae Yong Kwak
Sung Hyun Kim
Suk Joong Oh
Dae Young Zang
Hawk Kim
Jeong A. Kim
Young Rok Do
Hyeoung Joon Kim
Joon Seong Park
Chul Won Choi
Won Sik Lee
Yeung Chul Mun
Jee Hyun Kong
Joo Seop Chung
Ho Jin Shin
Dae Young Kim
Jinny Park
Chul Won Jung
Udomsak Bunworasate
Narcisa Sonia Comia
Saengsuree Jootar
Arry Harryanto Reksodiputro
Priscilla B. Caguioa
Sung Eun Lee
Dong Wook Kim
Chonbuk National University, School of Medicine
Dong-A University
SungKyunKwan University, School of Medicine
Hallym University
University of Ulsan, College of Medicine
The Catholic University of Korea
Keimyung University, Dongsan Medical Center
Chonnam National University
Ajou University
Korea University
Inje University Paik Hospital
Ewha Womans University School of Medicine
Wonju Severance Christian Hospital
Pusan National University, College of Medicine
Gachon University
Chulalongkorn University
Mary Mediatrix Medical Center
Mahidol University
University of Indonesia, RSUPN Dr. Cipto Mangunkusumo
St. Luke's Medical Center Quezon City
Keywords: Biochemistry, Genetics and Molecular Biology
Issue Date: 1-Dec-2017
Citation: Clinical Cancer Research. Vol.23, No.23 (2017), 7180-7188
Abstract: ©2017 AACR. 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 ¼ 79) or 400 mg twice-daily (n ¼ 81), or imatinib 400 mg daily (n ¼ 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 ¼ 0.0044 and P ¼ 0.0342, respectively). Complete cytogenetic response (CCyR) rates by 12 months were higher for radotinib 300 mg (91%) versus imatinib (77%; P ¼ 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 as NCT01511289.
ISSN: 15573265
Appears in Collections:Scopus 2016-2017

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