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在局部晚期直肠癌中基于trifluridine/tipiracil的化学辐射:第I/II阶段TARC试验

Benjamin Thiele¹, Alexander Stein², Christoph Schultheiß¹

¹Medical Oncology, University Hospital Basel, Basel, Switzerland; Laboratory of Translational Immuno-Oncology, Department of Biomedicine, University and University Hospital Basel, Basel, Switzerland.

Clinical colorectal cancer

|July 13, 2024

概括

这项研究表明,将三里丁/提皮拉西尔与放射治疗结合起来,对于直肠癌是可行的. 无细胞瘤DNA (ctDNA) 显示出监测治疗反应的潜力.

科学领域:

在瘤学瘤学.
胃肠病学胃肠病学
药理学药理学是指药理学的学科.

背景情况:

优化功能结果和长期缓解在局部高级直肠癌管理中至关重要.
新辅助疗法旨在改善治疗疗效和患者预后.
整合新药和监测工具可以增强治疗策略.

研究的目的:

评估新辅助剂trifluridine/tipiracil与直肠癌放射治疗相结合的可行性和耐受性.
探索无细胞瘤DNA (ctDNA) 在新辅助治疗后监测残留疾病的实用性.
在这个设置中确定三里丁/提皮拉西尔的最大耐受剂量 (MTD).

主要方法:

一个I期剂量升级研究 (3+3设计) 招募了10名患者.
三里丁/提皮拉西尔与放射治疗同时使用.
在化学辐射前后使用患者个性化的数字滴滴PCR监测无细胞瘤DNA (ctDNA).

主要成果:

三里丁/提皮拉西尔的MTD被确定为2×35 mg/m2,没有剂量限制性毒性.
3级不良事件主要是血液学 (贫血,白血病).
化学辐射在1/8的患者中实现了病理完整反应,大多数患者的病期下降;ctDNA监测显示了潜力,但需要验证.

结论:

新辅助剂trifluridine/tipiracil和放射治疗组合是可行的,可以容忍的,并显示了初步的疗效.
液体活检 (ctDNA) 显示为新辅助性直肠癌治疗中治疗降级的标志物.
为了液体活检的临床应用,需要进一步的前性研究和验证.

关键词:

生物标志物的研究研究.化学疗法或放射疗法临床试验临床试验是指临床试验的临床试验.液体活检液体活检新辅助治疗新辅助治疗

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