Eli Lilly and Company, Indianapolis, IN 46225, USA.
ImmunoGen, Waltham, MA 02451, USA.
Future Oncol. 2022 Jul;18(21):2667-2682. doi: 10.2217/fon-2022-0310. Epub 2022 May 25.
To assess invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor-positive, HER2-negative early breast cancer with combined clinicopathological criteria from monarchE, a phase III study of abemaciclib. US electronic health records were used to compare outcomes between high-risk (≥4 lymph nodes, or 1-3 lymph nodes and grade 3, tumor ≥5 cm or Ki-67 ≥20%) versus nonhigh-risk groups using Kaplan-Meier methods and Cox regression models. The high-risk group (n = 557) was at higher risk for IDFS and DRFS events than the nonhigh-risk group (n = 3471). IDFS events (hazard ratio: 3.07; 95% CI: 2.45-3.83) and DRFS events (hazard ratio: 3.15; 95% CI: 2.49-3.97) were significantly higher for the high-risk group. Risk of recurrence was three-times greater in the high-risk group, highlighting the need for better therapies.
评估 monarchE 试验中联合临床病理标准的激素受体阳性、HER2 阴性早期乳腺癌的无侵袭性疾病生存（IDFS）和远处无复发生存（DRFS）。利用美国电子健康记录，通过 Kaplan-Meier 方法和 Cox 回归模型，比较高危（≥4 个淋巴结，或 1-3 个淋巴结且 3 级、肿瘤≥5cm 或 Ki-67≥20%）与非高危（n=3471）组的结局。高危组（n=557）发生 IDFS 和 DRFS 事件的风险高于非高危组（n=3471）。高危组的 IDFS 事件（风险比：3.07；95%CI：2.45-3.83）和 DRFS 事件（风险比：3.15；95%CI：2.49-3.97）显著更高。高危组的复发风险增加了三倍，这突显了对更好疗法的需求。
