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)
- Authors
- Do, Young Rok; Kwak, Jae-Yong; Kim, Jeong A.; Kim, Hyeoung Joon; Chung, Joo Seop; Shin, Ho-Jin; Kim, Sung-Hyun; Bunworasate, Udomsak; Choi, Chul Won; Zang, Dae Young; Oh, Suk Joong; Jootar, Saengsuree; Reksodiputro, Ary Harryanto; Lee, Won Sik; Mun, Yeung-Chul; Kong, Jee Hyun; Caguioa, Priscilla B.; Kim, Hawk; Park, Jinny; Kim, Dong-Wook
- Issue Date
- Apr-2020
- Publisher
- WILEY
- Keywords
- chronic myeloid leukaemia; imatinib; newly diagnosed; long-term data; radotinib
- Citation
- BRITISH JOURNAL OF HAEMATOLOGY, v.189, no.2, pp.303 - 312
- Journal Title
- BRITISH JOURNAL OF HAEMATOLOGY
- Volume
- 189
- Number
- 2
- Start Page
- 303
- End Page
- 312
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/17834
- DOI
- 10.1111/bjh.16381
- ISSN
- 0007-1048
- Abstract
- 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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