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 |
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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.available | 2020-11-02T08:02:20Z | - |
dc.date.issued | 2017-12 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.issn | 1557-3265 | - |
dc.identifier.uri | https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/4347 | - |
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.format.extent | 9 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | AMER ASSOC CANCER RESEARCH | - |
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.publisher.location | 미국 | - |
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.citation.title | CLINICAL CANCER RESEARCH | - |
dc.citation.volume | 23 | - |
dc.citation.number | 23 | - |
dc.citation.startPage | 7180 | - |
dc.citation.endPage | 7188 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | sci | - |
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 | - |
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