达沙替尼的早期减量不会影响慢性髓性白血病患者的临床疗效:两项前瞻性试验的对比分析。

IF 2.1 4区 医学 Q3 HEMATOLOGY
Dong-Yeop Shin , Sahee Park , Eunjung Jang , Jee Hyun Kong , Young-Woong Won , Sukjoong Oh , Yunsuk Choi , Jeong-A Kim , Se Won Lee , Yeung-Chul Mun , Hawk Kim , Sung-Hyun Kim , Young Rok Do , Jae-Yong Kwak , Hyeoung-Joon Kim , Dae Young Zang , Sung-Nam Lim , Won Sik Lee , Dong-Wook Kim
{"title":"达沙替尼的早期减量不会影响慢性髓性白血病患者的临床疗效:两项前瞻性试验的对比分析。","authors":"Dong-Yeop Shin ,&nbsp;Sahee Park ,&nbsp;Eunjung Jang ,&nbsp;Jee Hyun Kong ,&nbsp;Young-Woong Won ,&nbsp;Sukjoong Oh ,&nbsp;Yunsuk Choi ,&nbsp;Jeong-A Kim ,&nbsp;Se Won Lee ,&nbsp;Yeung-Chul Mun ,&nbsp;Hawk Kim ,&nbsp;Sung-Hyun Kim ,&nbsp;Young Rok Do ,&nbsp;Jae-Yong Kwak ,&nbsp;Hyeoung-Joon Kim ,&nbsp;Dae Young Zang ,&nbsp;Sung-Nam Lim ,&nbsp;Won Sik Lee ,&nbsp;Dong-Wook Kim","doi":"10.1016/j.leukres.2024.107542","DOIUrl":null,"url":null,"abstract":"<div><p>Dasatinib is a potent second-generation tyrosine kinase inhibitor (TKI) used as a first-line treatment option for patients with chronic myeloid leukemia (CML). Currently, dose modification due to adverse events (AEs) is common in patients treated with dasatinib. This study compared the outcomes of two sequential prospective trials that enrolled patients with newly diagnosed chronic phase of CML (CP-CML) and initiated dasatinib at a starting dose of 100 mg daily. In the PCR-DEPTH study, CP-CML patients who started dasatinib 100 mg daily were enrolled and followed up, while in the DAS-CHANGE study, when patients achieved early molecular response with any grade of AEs were enrolled and treated with dasatinib 80 mg once daily. A total of 102 patients (PCR-DEPTH) and 90 patients (DAS-CHANGE) were compared. Although the median value of the relative dose intensity (RDI) of dasatinib was significantly higher in PCR-DEPTH than in DAS-CHANGE (99.6 % vs. 80.1 %, p &lt;0.001), the MMR rate at 12months showed a trend toward superiority in DAS-CHANGE compared to PCR-DEPTH (77.1 % vs 65.2 %, p = 0.084). The frequencies of MR4.0 at 24 and 36 months were higher in DAS-CHANGE than in PCR-DEPTH (44.4 % vs 28.8 %, p = 0.052 and 63.6 % vs 40.3 %, p= 0.013, respectively). RDIs were not different according to the MMR, MR4.0 or MR4.5 in analyses using a pooled population. Our results suggest that early dose reduction of dasatinib does not compromise efficacy in patients achieving EMR at 3 months and could be an interventional strategy for improving long term outcomes.</p></div>","PeriodicalId":18051,"journal":{"name":"Leukemia research","volume":"143 ","pages":"Article 107542"},"PeriodicalIF":2.1000,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Early dose reduction of dasatinib does not compromise clinical outcomes in patients with chronic myeloid leukemia: A comparative analysis of two prospective trials\",\"authors\":\"Dong-Yeop Shin ,&nbsp;Sahee Park ,&nbsp;Eunjung Jang ,&nbsp;Jee Hyun Kong ,&nbsp;Young-Woong Won ,&nbsp;Sukjoong Oh ,&nbsp;Yunsuk Choi ,&nbsp;Jeong-A Kim ,&nbsp;Se Won Lee ,&nbsp;Yeung-Chul Mun ,&nbsp;Hawk Kim ,&nbsp;Sung-Hyun Kim ,&nbsp;Young Rok Do ,&nbsp;Jae-Yong Kwak ,&nbsp;Hyeoung-Joon Kim ,&nbsp;Dae Young Zang ,&nbsp;Sung-Nam Lim ,&nbsp;Won Sik Lee ,&nbsp;Dong-Wook Kim\",\"doi\":\"10.1016/j.leukres.2024.107542\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Dasatinib is a potent second-generation tyrosine kinase inhibitor (TKI) used as a first-line treatment option for patients with chronic myeloid leukemia (CML). Currently, dose modification due to adverse events (AEs) is common in patients treated with dasatinib. This study compared the outcomes of two sequential prospective trials that enrolled patients with newly diagnosed chronic phase of CML (CP-CML) and initiated dasatinib at a starting dose of 100 mg daily. In the PCR-DEPTH study, CP-CML patients who started dasatinib 100 mg daily were enrolled and followed up, while in the DAS-CHANGE study, when patients achieved early molecular response with any grade of AEs were enrolled and treated with dasatinib 80 mg once daily. A total of 102 patients (PCR-DEPTH) and 90 patients (DAS-CHANGE) were compared. Although the median value of the relative dose intensity (RDI) of dasatinib was significantly higher in PCR-DEPTH than in DAS-CHANGE (99.6 % vs. 80.1 %, p &lt;0.001), the MMR rate at 12months showed a trend toward superiority in DAS-CHANGE compared to PCR-DEPTH (77.1 % vs 65.2 %, p = 0.084). The frequencies of MR4.0 at 24 and 36 months were higher in DAS-CHANGE than in PCR-DEPTH (44.4 % vs 28.8 %, p = 0.052 and 63.6 % vs 40.3 %, p= 0.013, respectively). RDIs were not different according to the MMR, MR4.0 or MR4.5 in analyses using a pooled population. Our results suggest that early dose reduction of dasatinib does not compromise efficacy in patients achieving EMR at 3 months and could be an interventional strategy for improving long term outcomes.</p></div>\",\"PeriodicalId\":18051,\"journal\":{\"name\":\"Leukemia research\",\"volume\":\"143 \",\"pages\":\"Article 107542\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-06-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Leukemia research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0145212624001085\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Leukemia research","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0145212624001085","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

达沙替尼是一种强效的第二代酪氨酸激酶抑制剂(TKI),是慢性髓性白血病(CML)患者的一线治疗选择。目前,在接受达沙替尼治疗的患者中,因不良事件(AEs)而调整剂量的情况很常见。本研究比较了两项连续前瞻性试验的结果,这两项试验招募了新诊断的慢性期CML(CP-CML)患者,达沙替尼的起始剂量为每天100毫克。在PCR-DEPTH研究中,CP-CML患者开始服用达沙替尼100毫克/天,并接受随访;而在DAS-CHANGE研究中,当患者获得早期分子反应并出现任何等级的AEs时,患者开始服用达沙替尼80毫克/天,并接受治疗。共有102名患者(PCR-DEPTH)和90名患者(DAS-CHANGE)进行了比较。尽管达沙替尼相对剂量强度(RDI)的中位值在PCR-DEPTH中明显高于DAS-CHANGE(99.6% vs. 80.1%,p
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Early dose reduction of dasatinib does not compromise clinical outcomes in patients with chronic myeloid leukemia: A comparative analysis of two prospective trials

Dasatinib is a potent second-generation tyrosine kinase inhibitor (TKI) used as a first-line treatment option for patients with chronic myeloid leukemia (CML). Currently, dose modification due to adverse events (AEs) is common in patients treated with dasatinib. This study compared the outcomes of two sequential prospective trials that enrolled patients with newly diagnosed chronic phase of CML (CP-CML) and initiated dasatinib at a starting dose of 100 mg daily. In the PCR-DEPTH study, CP-CML patients who started dasatinib 100 mg daily were enrolled and followed up, while in the DAS-CHANGE study, when patients achieved early molecular response with any grade of AEs were enrolled and treated with dasatinib 80 mg once daily. A total of 102 patients (PCR-DEPTH) and 90 patients (DAS-CHANGE) were compared. Although the median value of the relative dose intensity (RDI) of dasatinib was significantly higher in PCR-DEPTH than in DAS-CHANGE (99.6 % vs. 80.1 %, p <0.001), the MMR rate at 12months showed a trend toward superiority in DAS-CHANGE compared to PCR-DEPTH (77.1 % vs 65.2 %, p = 0.084). The frequencies of MR4.0 at 24 and 36 months were higher in DAS-CHANGE than in PCR-DEPTH (44.4 % vs 28.8 %, p = 0.052 and 63.6 % vs 40.3 %, p= 0.013, respectively). RDIs were not different according to the MMR, MR4.0 or MR4.5 in analyses using a pooled population. Our results suggest that early dose reduction of dasatinib does not compromise efficacy in patients achieving EMR at 3 months and could be an interventional strategy for improving long term outcomes.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Leukemia research
Leukemia research 医学-血液学
CiteScore
4.00
自引率
3.70%
发文量
259
审稿时长
1 months
期刊介绍: Leukemia Research an international journal which brings comprehensive and current information to all health care professionals involved in basic and applied clinical research in hematological malignancies. The editors encourage the submission of articles relevant to hematological malignancies. The Journal scope includes reporting studies of cellular and molecular biology, genetics, immunology, epidemiology, clinical evaluation, and therapy of these diseases.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信