Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 문영철 | * |
dc.date.accessioned | 2018-12-07T16:30:15Z | - |
dc.date.available | 2018-12-07T16:30:15Z | - |
dc.date.issued | 2017 | * |
dc.identifier.issn | 1078-0432 | * |
dc.identifier.other | OAK-21644 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/247249 | - |
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 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. ©2017 AACR. | * |
dc.description.sponsorship | Novartis | * |
dc.language | English | * |
dc.publisher | American Association for Cancer Research Inc. | * |
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.relation.issue | 23 | * |
dc.relation.volume | 23 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 7180 | * |
dc.relation.lastpage | 7188 | * |
dc.relation.journaltitle | Clinical Cancer Research | * |
dc.identifier.doi | 10.1158/1078-0432.CCR-17-0957 | * |
dc.identifier.wosid | WOS:000416908200005 | * |
dc.identifier.scopusid | 2-s2.0-85037616835 | * |
dc.author.google | Kwak J.-Y. | * |
dc.author.google | Kim S.-H. | * |
dc.author.google | Oh S.J. | * |
dc.author.google | Zang D.Y. | * |
dc.author.google | Kim H. | * |
dc.author.google | Kim J.-A. | * |
dc.author.google | Do Y.R. | * |
dc.author.google | Kim H.J. | * |
dc.author.google | Park J.S. | * |
dc.author.google | Choi C.W. | * |
dc.author.google | Lee W.S. | * |
dc.author.google | Mun Y.-C. | * |
dc.author.google | Kong J.H. | * |
dc.author.google | Chung J.S. | * |
dc.author.google | Shin H.-J. | * |
dc.author.google | Kim D.-Y. | * |
dc.author.google | Park J. | * |
dc.author.google | Jung C.W. | * |
dc.author.google | Bunworasate U. | * |
dc.author.google | Comia N.S. | * |
dc.author.google | Jootar S. | * |
dc.author.google | Reksodiputro A.H. | * |
dc.author.google | Caguioa P.B. | * |
dc.author.google | Lee S.-E. | * |
dc.author.google | Kim D.-W. | * |
dc.contributor.scopusid | 문영철(7003363716) | * |
dc.date.modifydate | 20240422115947 | * |