Publication:
Phase III clinical trial (RERISE study) results of efficacy and safety of radotinib compared with imatinib in newly diagnosed chronic phase chronic myeloid leukemia

Issued Date

2017-12-01

Resource Type

Article

ISSN

15573265
10780432

DOI

10.1158/1078-0432.CCR-17-0957

Other identifier(s)

2-s2.0-85037616835

Rights

Mahidol University

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SCOPUS

Bibliographic Citation

Clinical Cancer Research. Vol.23, No.23 (2017), 7180-7188

Suggested Citation

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 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. Vol.23, No.23 (2017), 7180-7188. doi:10.1158/1078-0432.CCR-17-0957 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/41700

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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

Author(s)

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

Other Contributor(s)

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

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 www.clinicaltrials.gov as NCT01511289.

Keyword(s)

Biochemistry, Genetics and Molecular Biology

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/41700

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Scopus 2016-2017