循环瘤细胞计数驱动的治疗选择在晚期乳腺癌的整体存活率:一个随机试验
François-Clément Bidard1,2, Nicolas Kiavue1, William Jacot3
1Department of Medical Oncology, INSERM CIC 1428, Institut Curie, Paris and Saint-Cloud, France.
概括
与高级乳腺癌的标准治疗相比,循环瘤细胞 (CTC) 数量在整体存活期 (OS) 中没有显著差异. 然而,CTC确定了那些比内分泌疗法更受益于化疗的患者.
科学领域:
- 在瘤学瘤学.
- 翻译研究是翻译研究.
背景情况:
- 临床试验经常在可获得二次终点之前报告初级终点.
- 之前的STIC CTC试验数据显示,循环瘤细胞 (CTC) 数量与研究人员选择的高级乳腺癌无进展生存率不相差.
研究的目的:
- 报告从STIC CTC试验中获得的二次终点总生存 (OS) 结果.
- 评估CTC计数在指导先进乳腺癌的第一线治疗决策中的临床实用性.
主要方法:
- 随机试验比较研究人员选择的治疗与CTC计数指导的治疗 (CellSearch试验).
- 患有激素受体阳性,HER2阴性晚期乳腺癌的患者被分为1:1的治疗臂.
- 在平均4.7年的随访后评估了OS.
主要成果:
- 在CTC手臂中,中位 OS 为51.3个月,而在标准手臂中为45.5个月 (HR 0.85;P=.11).
- 在推内分泌治疗 (ET) 但CTC计数高 (≥5CTC/7.5毫升) 的患者中,化疗显著改善了OS (HR0.53;P=.001).
结论:
- 与标准护理相比,循环瘤细胞 (CTC) 数量引导治疗没有显著改善整体存活率.
- CTC计数在识别晚期乳腺癌患者中具有临床实用性,这些患者在与临床医生的建议不一致时,可以从化疗中获益,而不是ET.
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