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Title: Long-term data from a phase 3 study of radotinib versus imatinib in patients with newly diagnosed, chronic myeloid leukaemia in the chronic phase (RERISE)
Authors: Young Rok Do
Jae Yong Kwak
Jeong A. Kim
Hyeoung Joon Kim
Joo Seop Chung
Ho Jin Shin
Sung Hyun Kim
Udomsak Bunworasate
Chul Won Choi
Dae Young Zang
Suk Joong Oh
Saengsuree Jootar
Ary Harryanto Reksodiputro
Won Sik Lee
Yeung Chul Mun
Jee Hyun Kong
Priscilla B. Caguioa
Hawk Kim
Jinny Park
Dong Wook Kim
Wonju Severance Christian Hospital
Keimyung University, Dongsan Medical Center
Inje University Paik Hospital
Gachon University
University of Indonesia, RSUPN Dr. Cipto Mangunkusumo
Ewha Womans University School of Medicine
Chulalongkorn University
Hallym University
Jeonbuk National University, School of Medicine
SungKyunKwan University, School of Medicine
Dong-A University
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Chonnam National University
Korea University
Pusan National University, College of Medicine
The Catholic University of Korea
St. Luke’s Medical Center
Keywords: Medicine
Issue Date: 1-Jan-2020
Citation: British Journal of Haematology. (2020)
Abstract: © 2019 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd In the phase 3 study RERISE, patients with newly diagnosed chronic myeloid leukaemia in chronic phase demonstrated significantly faster and higher rates of major molecular response (MMR) with twice-daily radotinib 300 mg (n = 79) or 400 mg (n = 81) than with once-daily imatinib 400 mg (n = 81) after 12 months. With ≥48 months’ follow-up, MMR was higher with radotinib 300 mg (86%) or 400 mg (83%) than with imatinib (75%). Among patients with BCR-ABL1 ≤ 10% at three months, MMR and molecular response 4·5 (MR4·5) were achieved within 48 months by more radotinib-treated patients (300 mg: 84% and 52%, respectively; 400 mg: 74% and 44%, respectively) than imatinib-treated patients (71% and 44%, respectively). Estimated overall and progression-free survival rates at 48 months were not significantly different between imatinib (94% and 94%, respectively) and radotinib 300 mg (99% and 97%, respectively) or 400 mg (95% and 93%, respectively). The treatment failure rate was significantly higher with imatinib (19%) than with radotinib 300 mg (6%; P = 0·0197) or 400 mg (5%; P = 0·0072). Safety profiles were consistent with previous reports; most adverse events occurred within 12 months. Radotinib continues to demonstrate robust, deep molecular responses, suggesting that treatment-free remission may be attainable.
ISSN: 13652141
Appears in Collections:Scopus 2020

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