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Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
- Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
- Kwak, Jae-Yong; Kim, Sung-Hyun; Oh, Suk Joong; Zang, Dae Young; Kim, Hawk; Kim, Jeong-A; Do, Young Rok; Kim, Hyeoung Joon; Park, Joon Seong; Choi, Chul Won; Lee, Won Sik; Mun, Yeung-Chul; Kong, Jee Hyun; Chung, Joo Seop; Shin, Ho-Jin; Kim, Dae-Young; Park, Jinny; Jung, Chul Won; Bunworasate, Udomsak; Comia, Narcisa Sonia; Jootar, Saengsuree; Reksodiputro, Arry Harryanto; Caguioa, Priscilla B.; Lee, Sung-Eun; Kim, Dong-Wook
- Ewha Authors
- SCOPUS Author ID
- Issue Date
- Journal Title
- CLINICAL CANCER RESEARCH
- 1078-0432; 1557-3265
- vol. 23, no. 23, pp. 7180 - 7188
- AMER ASSOC CANCER RESEARCH
- SCI; SCIE; SCOPUS
- 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.
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