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Determination of a radotinib dosage regimen based on dose-response relationships for the treatment of newly diagnosed patients with chronic myeloid leukemia
DC Field | Value | Language |
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dc.contributor.author | Noh, Hayeon | - |
dc.contributor.author | Jung, Su Young | - |
dc.contributor.author | Kwak, Jae-Yong | - |
dc.contributor.author | Kim, Sung-Hyun | - |
dc.contributor.author | Oh, Suk Joong | - |
dc.contributor.author | Zang, Dae Young | - |
dc.contributor.author | Lee, Suhyun | - |
dc.contributor.author | Park, Hye Lin | - |
dc.contributor.author | Jo, Dae Jin | - |
dc.contributor.author | Shin, Jae Soo | - |
dc.contributor.author | Do, Young Rok | - |
dc.contributor.author | Kim, Dong-Wook | - |
dc.contributor.author | Lee, Jangik, I | - |
dc.date.accessioned | 2023-12-11T00:36:38Z | - |
dc.date.available | 2023-12-11T00:36:38Z | - |
dc.date.created | 2019-03-28 | - |
dc.date.created | 2019-03-28 | - |
dc.date.issued | 2018-05 | - |
dc.identifier.citation | Cancer Medicine, Vol.7 No.5, pp.1766-1773 | - |
dc.identifier.issn | 2045-7634 | - |
dc.identifier.uri | https://hdl.handle.net/10371/197679 | - |
dc.description.abstract | Radotinib is a second-generation BCR-ABL1 tyrosine kinase inhibitor approved for the treatment of chronic myeloid leukemia in chronic phase (CP-CML). Here, using the data from a Phase 3 study conducted in patients with newly diagnosed CP-CML, the dose-efficacy as well as dose-safety relationship analyses were performed to determine a safe and effective initial dosage regimen of radotinib. A significant positive association was detected between the starting dose of radotinib adjusted for body weight (Dose/BW) and the probability of dose-limiting toxicity (>= grade 3 hematologic and nonhematologic toxicity) (P = 0.003). In contrast, a significant inverse association was discovered between Dose/BW and the probability of major molecular response (BCR-ABL1 / ABL1 <= 0.1%) when controlled for sex (P = 0.033). Moreover, frequent dose interruptions and reductions secondary to radotinib toxicities occurred in the Phase 3 study, resulting in nearly half (44%) of patients receiving a reduced dose at a 12-month follow-up. In conclusion, the results of this study demonstrate the need for initial radotinib dose attenuation to improve the long-term efficacy and safety of radotinib. Hence, the authors suggest a new upfront radotinib dose of 400 mg once daily be tested in patients with newly diagnosed CP-CML. | - |
dc.language | 영어 | - |
dc.publisher | John Wiley and Sons Ltd | - |
dc.title | Determination of a radotinib dosage regimen based on dose-response relationships for the treatment of newly diagnosed patients with chronic myeloid leukemia | - |
dc.type | Article | - |
dc.identifier.doi | 10.1002/cam4.1436 | - |
dc.citation.journaltitle | Cancer Medicine | - |
dc.identifier.wosid | 000431972900019 | - |
dc.identifier.scopusid | 2-s2.0-85044483545 | - |
dc.citation.endpage | 1773 | - |
dc.citation.number | 5 | - |
dc.citation.startpage | 1766 | - |
dc.citation.volume | 7 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Lee, Jangik, I | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | KINASE INHIBITOR OPTIMIZATION | - |
dc.subject.keywordPlus | CHRONIC MYELOGENOUS LEUKEMIA | - |
dc.subject.keywordPlus | IMATINIB PLASMA-LEVELS | - |
dc.subject.keywordPlus | BODY-MASS INDEX | - |
dc.subject.keywordPlus | CHRONIC-PHASE | - |
dc.subject.keywordPlus | TYROSINE KINASE | - |
dc.subject.keywordPlus | JAPANESE PATIENTS | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | SUNITINIB | - |
dc.subject.keywordAuthor | Chronic myeloid leukemia | - |
dc.subject.keywordAuthor | dose determination | - |
dc.subject.keywordAuthor | dose-response relationship | - |
dc.subject.keywordAuthor | radotinib | - |
dc.subject.keywordAuthor | tyrosine kinase inhibitor | - |
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