Long-term data from a phase 3 study of radotinib versus imatinib in patients with newly diagnosed, chronic myeloid leukaemia in the chronic phase (RERISE)
- 주제(키워드) chronic myeloid leukaemia , imatinib , newly diagnosed , long-term data , radotinib
- 주제(기타) Hematology
- 설명문(일반) [Do, Young Rok] Keimyung Univ, Dongsan Med Ctr, Daegu, South Korea; [Kwak, Jae-Yong] Chonbuk Natl Univ, Med Sch & Hosp, Jeonju, South Korea; [Kim, Jeong A.] Catholic Univ Korea, St Vincent Hosp, Suwon, South Korea; [Kim, Hyeoung Joon] Chonnam Natl Univ, Hwasun Hosp, Hwasun, South Korea; [Chung, Joo Seop; Shin, Ho-Jin] Pusan Natl Univ Hosp, Busan, South Korea; [Kim, Sung-Hyun] Dong A Univ, Med Ctr, Busan, South Korea; [Bunworasate, Udomsak] Chulalongkorn Univ, King Chulalongkorn Mem Hosp, Bangkok, Thailand; [Choi, Chul Won] Korea Univ, Guro Hosp, Seoul, South Korea; [Zang, Dae Young] Hallym Univ, Sacred Heart Hosp, Anyang, South Korea; [Oh, Suk Joong] Sungkyunkwan Univ, Kangbuk Samsung Hosp, Sch Med, Seoul, South Korea; [Jootar, Saengsuree] Mahidol Univ, Ramathibodi Hosp, Fac Med, Bangkok, Thailand; [Reksodiputro, Ary Harryanto] Cipto Mangunkusumo Hosp, Rumah Sakit Dr, Jakarta, Indonesia; [Lee, Won Sik] Inje Univ, Busan Paik Hosp, Busan, South Korea; [Mun, Yeung-Chul] Ewha Womans Univ, Coll Med, Seoul, South Korea; [Kong, Jee Hyun] Wonju Severance Christian Hosp, Wonju, South Korea; [Caguioa, Priscilla B.] St Lukes Med Ctr, Quezon City, Philippines; [Kim, Hawk; Park, Jinny] Gachon Univ, Gil Med Ctr, Coll Med, Incheon, South Korea; [Kim, Dong-Wook] Catholic Univ Korea, Seoul St Marys Hematol Hosp, Leukemia Res Inst, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Green Published, hybrid
- 발행기관 WILEY
- 발행년도 2020
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000174953
- 본문언어 영어
- Published As http://dx.doi.org/10.1111/bjh.16381
- PubMed https://pubmed.ncbi.nlm.nih.gov/32012231
초록/요약
In the phase 3 study RERISE, patients with newly diagnosed chronic myeloid leukaemia in chronic phase demonstrated significantly faster and higher rates of major molecular response (MMR) with twice-daily radotinib 300 mg (n = 79) or 400 mg (n = 81) than with once-daily imatinib 400 mg (n = 81) after 12 months. With >= 48 months' follow-up, MMR was higher with radotinib 300 mg (86%) or 400 mg (83%) than with imatinib (75%). Among patients with BCR-ABL1 <= 10% at three months, MMR and molecular response 4 center dot 5 (MR4 center dot 5) were achieved within 48 months by more radotinib-treated patients (300 mg: 84% and 52%, respectively; 400 mg: 74% and 44%, respectively) than imatinib-treated patients (71% and 44%, respectively). Estimated overall and progression-free survival rates at 48 months were not significantly different between imatinib (94% and 94%, respectively) and radotinib 300 mg (99% and 97%, respectively) or 400 mg (95% and 93%, respectively). The treatment failure rate was significantly higher with imatinib (19%) than with radotinib 300 mg (6%; P = 0 center dot 0197) or 400 mg (5%; P = 0 center dot 0072). Safety profiles were consistent with previous reports; most adverse events occurred within 12 months. Radotinib continues to demonstrate robust, deep molecular responses, suggesting that treatment-free remission may be attainable.
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