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在新辅助系统疗法后预测病理完整反应中遗漏乳腺外科手术:一个多中心,单臂,非劣势试验

Ji-Jung Jung¹, Jong-Ho Cheun², Soo-Yeon Kim³

¹Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.

Journal of breast cancer

|March 3, 2024

概括

这项研究调查了乳腺癌患者的遗漏乳腺手术,在新辅助系统治疗 (NST) 后获得完整的反应,使用MRI和真空辅助活检 (VAB) 来确认结果,旨在实现非劣势生存结果.

科学领域:

在瘤学瘤学.
乳腺癌研究研究乳腺癌研究
手术瘤学手术瘤学

背景情况:

新辅助全身疗法 (NST) 在乳腺癌中改善了病理完整反应 (pCR) 率.
真空辅助活检 (VAB) 显示了准确PCR评估的前景.
之前的研究为接受手术的pCR患者建立了生存基准.

研究的目的:

通过MRI和VAB后NST实现预测PCR后,在没有进行乳腺手术的患者中确认非劣质的5年无疾病生存期.
评估在精选的乳腺癌患者中省略乳腺手术的安全性和有效性.
评估对患者报告的生活质量的影响.

主要方法:

在韩国进行的前性,多中心,单臂,非劣势性研究 (OPTIMIST试验).
在NST后,注册了带有剪切标记和完全临床反应的患者 (NST后MRI尺寸≤1厘米,LSER≤1.6).
遗漏的乳房手术证实PCR;遗漏的手术,如果临床结节阴性和MRI标准满足 (≤0.5厘米).
对生存和疗效结果的五年评估.

主要成果:

本部分应在研究完成并获得结果后填写.

结论:

建立证据,以安全的遗漏的乳房手术在NST的异常响应者.
解决有关治疗不足,复发和改善患者生活质量的担忧.
对于精选的乳腺癌患者来说,有可能重塑临床实践,以减少侵入性方法.

关键词:

活检是为了检查生物质.乳腺新生体乳腺新生体临床试验临床试验多中心研究多中心研究新辅助疗法是一种新辅助疗法.

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