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)
- Title
- 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)
- Author
- 오석중
- Keywords
- chronic myeloid leukaemia; imatinib; newly diagnosed; long-term data; radotinib
- Issue Date
- 2020-04
- Publisher
- WILEY
- Citation
- BRITISH JOURNAL OF HAEMATOLOGY, v. 189, no. 2, page. 303-312
- 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.
- URI
- https://onlinelibrary.wiley.com/doi/10.1111/bjh.16381https://repository.hanyang.ac.kr/handle/20.500.11754/169050
- ISSN
- 0007-1048; 1365-2141
- DOI
- 10.1111/bjh.16381
- Appears in Collections:
- COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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