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; ChulWon 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
- Keimyung Author(s)
- Do, Young Rok
- Department
- Dept. of Internal Medicine (내과학)
- Journal Title
- Clinical Cancer Research
- Issued Date
- 2017
- Volume
- 23
- Issue
- 23
- 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. This trial was registered at www.clinicaltrials.gov as NCT01511289 Clin Cancer Res; 23(23); 7180-8. ©2017 AACR.
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