Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Kwak, Jae-Yong | - |
dc.contributor.author | Kim, Sung-Hyun | - |
dc.contributor.author | Oh, Suk Joong | - |
dc.contributor.author | Zang, Dae Young | - |
dc.contributor.author | Kim, Hawk | - |
dc.contributor.author | Kim, Jeong-A | - |
dc.contributor.author | Do, Young Rok | - |
dc.contributor.author | Kim, Hyeoung Joon | - |
dc.contributor.author | Park, Joon Seong | - |
dc.contributor.author | Choi, Chul Won | - |
dc.contributor.author | Lee, Won Sik | - |
dc.contributor.author | Mun, Yeung-Chul | - |
dc.contributor.author | Kong, Jee Hyun | - |
dc.contributor.author | Chung, Joo Seop | - |
dc.contributor.author | Shin, Ho-Jin | - |
dc.contributor.author | Kim, Dae-Young | - |
dc.contributor.author | Park, Jinny | - |
dc.contributor.author | Jung, Chul Won | - |
dc.contributor.author | Bunworasate, Udomsak | - |
dc.contributor.author | Comia, Narcisa Sonia | - |
dc.contributor.author | Jootar, Saengsuree | - |
dc.contributor.author | Reksodiputro, Arry Harryanto | - |
dc.contributor.author | Caguioa, Priscilla B. | - |
dc.contributor.author | Lee, Sung-Eun | - |
dc.contributor.author | Kim, Dong-Wook | - |
dc.date.accessioned | 2021-09-02T22:06:27Z | - |
dc.date.available | 2021-09-02T22:06:27Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017-12-01 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/81223 | - |
dc.description.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. (C) 2017 AACR. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | AMER ASSOC CANCER RESEARCH | - |
dc.subject | EARLY MOLECULAR RESPONSE | - |
dc.subject | DASATINIB | - |
dc.subject | NILOTINIB | - |
dc.subject | DASISION | - |
dc.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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Choi, Chul Won | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-17-0957 | - |
dc.identifier.scopusid | 2-s2.0-85037616835 | - |
dc.identifier.wosid | 000416908200005 | - |
dc.identifier.bibliographicCitation | CLINICAL CANCER RESEARCH, v.23, no.23, pp.7180 - 7188 | - |
dc.relation.isPartOf | CLINICAL CANCER RESEARCH | - |
dc.citation.title | CLINICAL CANCER RESEARCH | - |
dc.citation.volume | 23 | - |
dc.citation.number | 23 | - |
dc.citation.startPage | 7180 | - |
dc.citation.endPage | 7188 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | EARLY MOLECULAR RESPONSE | - |
dc.subject.keywordPlus | DASATINIB | - |
dc.subject.keywordPlus | NILOTINIB | - |
dc.subject.keywordPlus | DASISION | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
145 Anam-ro, Seongbuk-gu, Seoul, 02841, Korea+82-2-3290-2963
COPYRIGHT © 2021 Korea University. All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.