与Datopotamab Deruxtecan相关的选择性不良事件:临床实践和预防,监测和管理的机构协议
Aaron Lisberg1, Laura A Huppert2, Balazs Halmos3
1David Geffen School of Medicine at UCLA, Santa Monica, CA, USA.
The oncologist
|July 23, 2025
概括
达托帕马布德鲁克斯泰干 (Dato-DXd) 在先前治疗过转移性非小细胞肺癌和转移性乳腺癌的患者中显著改善了无进展生存率. 这一分析为管理与治疗相关的不良事件提供了实际见解,以改善患者的治疗结果.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 达托帕马布德鲁克斯泰坎 (Dato-DXd) 是一种抗体-药物结合物,向于多细胞细胞表面抗原2,在各种固体瘤中表达.
- 以前用于转移性非小细胞肺癌 (mNSCLC) 和转移性乳腺癌 (mBC) 的治疗方法存在局限性.
研究的目的:
- 评估Dato-DXd在先前接受治疗的mNSCLC和激素受体阳性/人表皮生长因子受体2-阴性mBC患者中的疗效和安全性.
- 为管理与Dato-DXd.相关的与治疗相关的不良事件 (AE) 提供实际见解.
主要方法:
- TROPION-Lung01:第三期试验,将Dato-DXd与先前治疗的mNSCLC中的多塞塔塞尔进行比较.
- TROPION-Breast01:第三阶段试验,将Dato-DXd与研究人员选择的化学疗法进行比较,用于先前接受治疗的HR+/HER2-mBC.
- 对来自TROPION-Lung01和TROPION-Lung05.5的EGFR突变阳性NSCLC患者的组合分析.
主要成果:
- 在TROPION-Lung01中,Dato-DXd在mNSCLC中显著改善了无进展生存时间 (mPFS) 的中位数,而不是dcetaxel (4.4vs3.7个月).
- 亚组分析表明,PFS对非状mNSCLC和具有可操作基因组变化的mNSCLC有好处.
- 在TROPION-Breast01中,Dato-DXd在HR+/HER2-mBC中显著改善了与化疗相比的mPFS (6.9个月与4.9个月).
结论:
- 达托帕马布德鲁克斯坦在先前治疗的mNSCLC和HR+/HER2-mBC中显示出显著的疗效.
- 达托-DXd具有独特的安全性,需要对口腔粘膜炎,恶心,吐,眼部事件和间歇性肺部疾病等AEs采取实际的管理策略.
- 多学科团队的投入对于优化Dato-DXd治疗的患者体验和结果至关重要.
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