现实世界中的Regorafenib剂量升级与固定的剂量对抗性转移性结直肠癌的证据:来自ReTrITA研究的结果
Carlo Signorelli1, Michele Basso2, Maria Alessandra Calegari2
1Medical Oncology Unit, S.Rosa Hospital, ASL Viterbo, 01100 Viterbo, Italy.
Cancers
|October 29, 2025
概括
在转移性结直肠癌 (mCRC) 中,调高雷戈拉费尼布剂量可改善无进展生存率和耐受性,而不会影响整体生存率. 这项现实研究支持耐火性mCRC患者的个性化剂量策略.
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:
- 雷戈拉费尼布是耐火性转移性结直肠癌 (mCRC) 的标准治疗方法.
- 在ReDOS试验建议剂量升级提高耐受性和持久性.
- 这项研究分析了来自ReTrITA队列的现实数据.
研究的目的:
- 为了评估regorafenib剂量升级与耐火mCRC.固定剂量的疗效和安全性.
- 为了比较总生存率 (OS),无进展生存率 (PFS) 和安全概况.
- 在现实环境中验证ReDOS研究的发现.
主要方法:
- 意大利17个中心713名mCRC患者的回顾性分析 (2012-2023年).
- 患者分为类似ReDOS的剂量升级 (n=313) 和固定的剂量 (n=400) 组.
- 终点包括OS,PFS,客观响应率 (ORR),疾病控制率 (DCR),响应持续时间 (DoR) 和使用卡普兰-梅尔和考克斯模型分析的安全性.
主要成果:
- 组间的中位数OS没有显著差异 (7.4个月与6.7个月).
- 随着剂量升级,PFS显著改善 (3.1个月与3.9个月;HR 0.76,p=0.0007).
- 剂量升级显示,较低的3/4级不良事件 (35.4%与39.5%;p=0.0042) 的安全性更好,在特定亚组 (≥70岁,ECOG PS 0-1,RAS野生型,直肠初级) 中具有一致的PFS益处.
结论:
- 在现实世界耐火性mCRC治疗中,Regorafenib剂量升级是可行的和有益的.
- 升级可以改善PFS和耐受性,而不会影响OS.
- 支持个性化剂量作为常规瘤治疗mCRC.的实用策略.
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