突尼斯通用Docetaxel在早期乳腺癌中的耐受性:一项前性研究
Wala Ben Kridis1, Rim Sahnoun2, Chadha Maalej2
1Department of Medical Oncology, Habib Bourguiba Hospital University of Sfax, Sfax, Tunisia.
概括
这项研究发现,Cytotere®是一种仿制的多塞塔塞尔,其安全性与乳腺癌患者的原始药物相似. 建议对这种辅助化疗进行仔细监测.
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:
- 多塞塔克塞尔是治疗非转移性乳腺癌的关键化疗.
- 赛托特雷 (Cytotere®) 是一种本地生产的通用多塞塔克塞尔配方,自2017年以来在突尼斯使用.
- 尽管人们对仿制税种存在担忧,但Cytotere®的前性安全数据缺乏.
研究的目的:
- 评估Cytotere®在接受辅助化疗的非转移性乳腺癌患者的安全性.
- 为了确定与Cytotere®毒性相关的患者特征.
主要方法:
- 未来的,单心的观察性研究.
- 包括60名HER2阴性非转移性乳腺癌患者,接受Cytotere®治疗 (100毫克/米2每21天).
- 使用CTCAE v5.0分级的不良事件 (AEs);用法语贝高德方法评估因果关系;使用千平方测试进行统计分析.
主要成果:
- 最常见的副作用:喘息 (90%),关节痛/肌痛痛 (71.7%),粘膜炎 (50%),手脚综合征 (HFS) (36.7%).
- 3级毒性不常见 (16.7%),主要是HFS和中性质减退. 发烧性中性质发生在8.3%的患者中.
- 剂量减少 (23.3%) 与3级毒性 (p<0.001) 和HFS (p=0.008) 有关.
结论:
- 赛托特雷 (Cytotere®) 显示出与原始药物多塞塔塞尔 (docetaxel) 相当的安全性.
- 结果支持在辅助化疗中继续使用Cytotere®,并进行监测.
- 需要进行更大规模的研究来证实结果并指导药物监测,特别是在资源较少的环境中.
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