在mCRC的第一线治疗期间发生的不良事件:对三项随机试验的时间毒性 (ToxT) 分析
Alessandra Boccaccino1, Daniele Rossini1, Alessandra Raimondi2
1Unit of Oncology, University Hospital of Pisa, Pisa, Italy and Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Via Roma 67, 56126, Pisa, Italy.
European journal of cancer (Oxford, England : 1990)
|June 10, 2023
概括
时间毒性 (ToxT) 分析显示,大多数化疗不良事件 (AE) 在诱导后减少,但在转移性结直肠癌 (mCRC) 患者的维持期间,抗EGFRAE仍然存在.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 癌症治疗方法 癌症治疗方法
背景情况:
- 临床试验中的传统安全性评估侧重于高度和严重的不良事件 (AE).
- 对副作用的全面评估应考虑慢性低度事件,个体患者的体验和与时间相关的因素.
- 随时间的毒性 (ToxT) 分析提供了一种新的方法,特别是对于长期的,不那么密集的治疗,如转移性结直肠癌 (mCRC) 的维持疗法.
研究的目的:
- 将ToxT分析应用于TRIBE,TRIBE2和VALENTINO研究中的大量mCRC患者队列.
- 纵向描述AEs在整个治疗期间的演变.
- 为了比较诱导和维护策略之间的AE模式.
主要方法:
- 在随机试验中的mCRC患者中使用了ToxT (随时毒性) 评估.
- 在整个治疗周期中纵向分析了AE.
- 在各种化疗方案 (FOLFOXIRI,FOLFIRI,FOLFOX) 与贝瓦西祖马布或帕尼图穆马布结合的诱导和维持阶段之间比较了AE概况.
主要成果:
- 诱导后,一般和血液学AE的平均等级下降,FOLFOXIRI/bevacizumab仍然是最高的.
- 神经毒性随着周期的推移而增加,晚期高度发作.
- 抗VEGF的AE在早期是严重的,然后下降,而抗EGFR的AE在维持期间持续存在.
结论:
- 大多数与化疗相关的副作用,不包括手脚综合征和神经病变,在早期达到峰值,然后在积极管理下下降.
- 维护疗法,特别是贝瓦齐祖马布,可以缓解大多数AE.
- 与抗EGFR相关的副作用代表了独特的毒性概况,可以持续到维护阶段.
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