在三阴性乳腺癌的新辅助化疗免疫疗法期间,密集剂量与每周3次的AC相比,三阴性乳腺癌的新辅助化疗免疫疗法
Renata Colombo Bonadio1,2, Isadora Martins de Sousa3, Flávia Cavalcanti Balint3
1Instituto D'Or de Pesquisa e Ensino (IDOR), São Paulo, Brazil.
NPJ breast cancer
|August 14, 2024
概括
这项现实研究比较了两种新辅助 pembrolizumab 加上三阴性乳腺癌化疗的 antracycline-cyclophosphamide (AC) 方案. 剂量密集的AC显示了在III期疾病中更高的病理完整反应的趋势,但也显示了更多的不良事件.
科学领域:
- 在瘤学瘤学.
- 乳腺癌研究研究 乳腺癌研究
- 临床试验分析
背景情况:
- 新辅助药 pembrolizumab加化疗 (P+CT) 是治疗II-III期三阴性乳腺癌 (TNBC) 的标准.
- 在P+CT疗法中,最优的Anthracycline-cyclophosphamide (AC) 调度需要进一步的定义.
- 以前的研究表明,剂量密集的疗法在早期乳腺癌中具有潜在的益处.
研究的目的:
- 为了评估剂量密集AC (ddAC) 与标准3周AC (q3w AC) 的有效性和安全性,TNBC患者接受新辅助P+CT.
- 为了比较两种AC表之间的病理完整反应 (pCR) 和残留癌症负担 (RCB) 评分.
- 评估与每个AC疗法相关的安全概况,包括与每个AC疗法相关的不良事件 (AE).
主要方法:
- 这项Neo-Real研究是一项来自十个癌症中心的现实数据分析,评估了自2020年7月以来接受新辅助P+CT治疗的TNBC患者.
- 包括333名患者,其中311人完成了新辅助疗法,279人接受了手术,病理报告.
- 在接受ddAC (58.2%) 和q3w AC (41.8%) 的患者之间比较结果,重点关注II期和III期疾病亚组.
主要成果:
- 总的来说,pCR率在ddAC (65.4%) 和q3w AC (58.7%) 之间数字上更高,但在统计学上并不显著 (P=0.260).
- 与q3w AC (73.5%) 相比,RCB 0-1率在ddAC (82.4%) 中也更高,P=0.115.
- 第三阶段TNBC患者在ddAC中呈现了较高pCR的趋势 (59%对40%,P=0.155),而第二阶段的发病率相似. ddAC趋向于更高等级的≥3个AE (40.5%与30.7%,P=0.092).
结论:
- 新现实研究无法最终排除ddAC和q3w AC在TNBC新辅助P+CT中的差异.
- 在DDAC的第三阶段TNBC中潜在的更高的PCR需要进一步调查.
- 对 ddAC 的不良事件增加的趋势需要在临床实践中考虑.
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