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Optimization of radotinib doses for the treatment of Asian patients with chronic myelogenous leukemia based on dose-response relationship analyses

Authors
 Hayeon Noh  ;  Min Soo Park  ;  Sung-Hyun Kim  ;  Suk Joong Oh  ;  Dae Young Zang  ;  Hye Lin Park  ;  Dae Jin Cho  ;  Dong-Wook Kim  ;  Jangik I. Lee 
Citation
 LEUKEMIA & LYMPHOMA, Vol.57(8) : 1856-1864, 2016 
Journal Title
LEUKEMIA & LYMPHOMA
ISSN
 1042-8194 
Issue Date
2016
MeSH
Adult ; Aged ; Antineoplastic Agents/pharmacology* ; Antineoplastic Agents/therapeutic use ; Asian Continental Ancestry Group ; Benzamides/pharmacology* ; Benzamides/therapeutic use ; Body Surface Area ; Body Weight ; Dose-Response Relationship, Drug ; Drug Dosage Calculations ; Drug Resistance, Neoplasm ; Female ; Fusion Proteins, bcr-abl/antagonists & inhibitors* ; Humans ; Imatinib Mesylate/pharmacology ; Imatinib Mesylate/therapeutic use ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy* ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/genetics ; Male ; Middle Aged ; Philadelphia Chromosome ; Protein Kinase Inhibitors/pharmacology* ; Protein Kinase Inhibitors/therapeutic use ; Pyrazines/pharmacology* ; Pyrazines/therapeutic use ; Treatment Outcome ; Young Adult
Keywords
Radotinib ; chronic myelogenous leukemia ; dose optimization ; dose-response relationship ; tyrosine kinase inhibitor ; weight-based dosing
Abstract
A fixed dose regimen for tyrosine kinase inhibitors (TKIs) is postulated to be responsible for variable safety outcomes in the treatment of chronic myelogenous leukemia (CML). The objective of this study was to explore an optimal dosing regimen for a TKI, radotinib, to improve its safety profile. Clinical data were obtained from a Phase 2 study of fixed-dose radotinib in 77 Asian patients with CML. The magnitude of radotinib dose adjusted for patient's body weight (Dose/BW) and the probability of dose-limiting toxicity (DLT) demonstrated a positive association (Logit[P]?=?0.86*[Dose/BW]-4.45, p?=?0.001). There was a significant difference in the Kaplan-Meier curves for time to first DLT between the patient subgroups of Dose/BW?<6 and?≥6?mg/kg (259 versus 83 days). Consequently, a two-tier weight-based dosing regimen may improve the safety of radotinib: 300?mg or 400?mg twice daily for patients weighing?≤65 or?>65?kg, respectively.
Full Text
http://www.tandfonline.com/doi/full/10.3109/10428194.2015.1113278
DOI
10.3109/10428194.2015.1113278
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
Yonsei Authors
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/151869
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