在晚期固体瘤中进行基因组匹配疗法:随机二期ROME试验
Paolo Marchetti1, Giuseppe Curigliano2,3, Mauro Biffoni4
1Department of Oncology, IDI-IRCCS, Rome, Italy.
Nature medicine
|September 30, 2025
概括
与标准治疗相比,量身定制的治疗 (TT) 显著提高了先进的固体瘤的整体应答率和无进展生存率. 这种精确的瘤学方法对具有可操作的基因组改变的患者来说是有前途的.
科学领域:
- 在瘤学瘤学.
- 基因组学就是基因组学.
- 临床试验 临床试验
背景情况:
- 有限的随机证据表明精密瘤学比标准疗法更优越.
- 瘤不可知生物标志物显示出引导有效癌症治疗的潜力.
研究的目的:
- 为了在先进的固体瘤中比较量身定制的治疗 (TT) 与标准护理 (SoC).
- 以综合基因组分析为指导的精密瘤学的有效性和安全性进行评估.
主要方法:
- 多中心,随机化,开放标签第2阶段ROME试验.
- 组织和血液的综合基因组分析,以确定可操作的变化.
- 分子瘤委员会 (MTB) 的建议指导了治疗分配.
主要成果:
- 量身定制治疗 (TT) 导致整体反应率显著提高 (17.5%与10%,P = 0.0294).
- 中位数无进展生存期 (PFS) 改善了TT (3.5vs2.8个月,P = 0.0002).
- 在TT手臂中观察到优异的12个月PFS率 (22.0%对比8.3%).
结论:
- 以基因组分析和MTB建议为指导的量身定制治疗显著改善了晚期固体瘤的结果.
- 这些发现提供了支持瘤不可知精度瘤学策略的证据.
- TT证明了对具有多种可操作基因组变异的患者的潜力.
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The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
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The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
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