在未经治疗的不可切除的转移性结直肠癌中,交替修改的CAPOX/CAPIRI加贝瓦齐祖马布:一项2期试验
Sheng Li1, Xiaoyou Li1, Hanfeng Xu2
1Department of Medical Oncology, The Affiliated Cancer Hospital of Nanjing Medical University & Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, Nanjing, PR China.
Signal transduction and targeted therapy
|December 10, 2024
概括
这项研究发现,交替进行改性化疗 (capecitabine,oxaliplatin,irinotecan) 加上bevacizumab显示出对转移性结直肠癌有希望的疗效. 该疗法为患者提供了一个潜在的新选择,对患者有可控的副作用.
科学领域:
- 在瘤学瘤学.
- 医学瘤学 医学瘤学
- 临床试验 临床试验
背景情况:
- 转移性结直肠癌 (mCRC) 仍然是一个重大的健康挑战.
- 之前的研究表明,替换FOLFOX/FOLFIRI疗法对mCRC的疗效.
- 优化治疗未经治疗的不可切除的mCRC的治疗策略至关重要.
研究的目的:
- 评估CAPOX (capecitabine和oxaliplatin) 和CAPIRI (capecitabine和irinotecan) 加上贝瓦西祖马布在未经治疗的不可切割的mCRC中交替修饰的疗效和安全性.
- 确定无进展生存期 (PFS) 作为主要终点.
- 评估客观应答率,疾病控制,整体存活率和与治疗相关的不良事件.
主要方法:
- 一项2期临床试验 (NCT04324476) 涉及52名未经治疗且无法切除的mCRC患者.
- 诱导治疗:交替使用修改后的CAPOX/CAPIRI和贝瓦齐祖马布,长达6个28天周期.
- 维持治疗:卡佩奇他和贝瓦西祖马布.
- 主要终点:无进展生存率 (PFS).
主要成果:
- 中位数PFS为11.0个月.
- 客观应答率为73%,疾病控制率为94%.
- 平均整体生存时间为28.1个月. 与治疗相关的3-4级不良事件 (TRAE) 发生在33%的患者中,高血压是最常见的.
结论:
- 交替修改的CAPOX/CAPIRI加上贝瓦西祖马布在未经治疗的不可切割的mCRC中显示出有希望的疗效和可接受的安全性.
- 该疗法实现了显著的PFS,反应率和整体存活率.
- 这种组合疗法代表了这种患者群体的潜在新疗法选择.
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