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• W4361946213 abstract "<div>Abstract<p><b>Purpose:</b> 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.</p><p><b>Experimental Design:</b> 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.</p><p><b>Results:</b> Two hundred forty-one patients were randomized to receive radotinib 300 mg (<i>n</i> = 79) or 400 mg twice-daily (<i>n</i> = 81), or imatinib 400 mg daily (<i>n</i> = 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%; <i>P</i> = 0.0044 and <i>P</i> = 0.0342, respectively). Complete cytogenetic response (CCyR) rates by 12 months were higher for radotinib 300 mg (91%) versus imatinib (77%; <i>P</i> = 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.</p><p><b>Conclusions:</b> Radotinib demonstrated superiority over imatinib in CCyR and MMR in patients newly diagnosed with Philadelphia chromosome–positive CML-CP. This trial was registered at <a href=http://www.clinicaltrials.gov target=_blank>www.clinicaltrials.gov</a> as NCT01511289. <i>Clin Cancer Res; 23(23); 7180–8. ©2017 AACR</i>.</p></div>" @default.
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• W4361946213 date "2023-03-31" @default.
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• W4361946213 title "Data from Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia" @default.
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