在三阴性乳腺癌 (FUTURE-SUPER) 中优化一线亚型化治疗:多队列,随机化,第二阶段试验
Lei Fan1, Zhong-Hua Wang1, Lin-Xiaoxi Ma1
1Department of Breast Surgery, Fudan University Shanghai Cancer Center and Key Laboratory of Breast Cancer in Shanghai, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
The Lancet. Oncology
|January 11, 2024
概括
基于亚型的治疗显著改善了三阴性乳腺癌患者的无进展生存率. 这种个性化的方法为这种侵袭性癌症提供了一个有希望的新治疗策略.
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:
- 三阴性乳腺癌 (TNBC) 呈现出显著的分子和免疫异质性.
- 之前的分类确定了四种TNBC亚型:光类质受体 (LAR),免疫调节,基底类免疫抑制 (BLIS) 和介质类 (MES).
研究的目的:
- 评估基于亚型的治疗策略的疗效和安全性,作为TNBC的第一线治疗.
- 为了比较个性化,亚型导向的疗法与TNBC患者的标准化疗.
主要方法:
- FUTURE-SUPER试验是一个开放的,随机的第二阶段研究,涉及139名未经治疗的转移性或复发性TNBC的女性参与者.
- 参与者根据分子亚型和基因组生物标志物被分为五个队列,然后随机 (1:1) 接受单独的nab-paclitaxel或根据特定分子变化 (例如,针对LAR-HER2mut的pyrotinib,针对PI3K/AKT突变的everolimus,针对免疫调节亚型的camrelizumab/famitinib,针对BLIS/MES-PI3K/AKTWT的bevacizumab) 的基于亚型的疗法.
- 主要终点是研究人员评估的无进展生存期 (PFS).
主要成果:
- 基于分型的组合组显示,与对照组相比,PFS的中位数显著更长 (11.3个月),危险比率为0.44 (p<0.0001).
- 常见的3-4级不良事件包括中性质减退,贫血和亚型基组中的氨酸转移酶升高.
- 根据亚型分组的7名患者 (10%) 经历了严重的不良事件,没有任何治疗相关的死亡报告.
结论:
- 基于亚型的治疗优化在TNBC患者中显示出显著的临床益处.
- 这些发现支持在TNBC更大的第三阶段临床试验中进一步调查个性化治疗方案.
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