Merck & Co., Inc., Rahway, NJ, USA.
Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Department of Gynecology & Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
Future Oncol. 2024 Feb;20(6):335-348. doi: 10.2217/fon-2023-0315. Epub 2023 Aug 21.
This study evaluated event-free survival (EFS) as a surrogate outcome for overall survival (OS) in neoadjuvant therapy for early-stage triple-negative breast cancer (eTNBC). Meta-regression analyses based on a targeted literature review were used to evaluate the individual- and trial-level associations between EFS and OS. In the individual-level analyses, 3-year EFS was a significant predictor of 5-year OS (p < 0.01; coefficient of determinations [R]: 0.82 [95% CI: 0.68-0.91]). Additionally, there was a statistically significant association between the treatment effect on EFS and OS at the trial level (p < 0.001; R: 0.64 [95% CI: 0.45-0.82]). This study demonstrates significant associations between EFS and OS and suggests that EFS is a valid surrogate for OS following neoadjuvant therapy for eTNBC.
本研究评估了早期三阴性乳腺癌(eTNBC)新辅助治疗中无事件生存(EFS)作为总生存(OS)替代终点的价值。采用基于靶向文献综述的荟萃回归分析来评估 EFS 和 OS 之间的个体和试验水平关联。在个体水平分析中,3 年 EFS 是 5 年 OS 的显著预测因子(p<0.01;决定系数 [R]:0.82 [95% CI:0.68-0.91])。此外,试验水平 EFS 和 OS 的治疗效果之间存在统计学显著关联(p<0.001;R:0.64 [95% CI:0.45-0.82])。本研究表明 EFS 和 OS 之间存在显著关联,并提示 EFS 是 eTNBC 新辅助治疗后 OS 的有效替代终点。