Publication:
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)

Issued Date

2020-01-01

Resource Type

Article

ISSN

13652141
00071048

DOI

10.1111/bjh.16381

Other identifier(s)

2-s2.0-85078900629

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

British Journal of Haematology. (2020)

Suggested Citation

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 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). British Journal of Haematology. (2020). doi:10.1111/bjh.16381 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/53884

Research Projects

Organizational Units

Authors

Journal Issue

Thesis

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)

Author(s)

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

Other Contributor(s)

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

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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/123456789/53884

Collections

Scopus 2020