Overall survival with abemaciclib in early breast cancer.

The impact on overall survival(OS) remained unknown.

其对总生存（OS）的影响仍然未知。

patients_and_methods

In the phase III monarchE trial (NCT03155997), patients received ET for at least 5 years with or without abemaciclib for 2 years.

在III期monarchE试验(NCT03155997)中，患者至少接受5年的内分泌治疗（ET），有或没有2年的abemaciclib治疗。

In this article, we report the primary OS results, a key secondary endpoint, and updated estimates of IDFS and distant relapse-free survival (DRFS).

在本文中，我们报告了主要的总生存（OS）结果，这是一个关键的次要终点，以及无侵袭性疾病生存（IDFS）和远处复发无病生存（DRFS）的最新估计。

Results

Overall, 5637 patients underwent randomization, with 2808 assigned to abemaciclib-ET, and 2829 to ET.

总体而言，共有5637名患者进行了随机分组，其中2808名被分配到abemaciclib-ET组，2829名被分配到ET组。

In the intent-to-treat population, with a median follow-up of 76.2 months, abemaciclib-ET resulted in a 15.8% lower risk of death than ET [661 deaths; hazard ratio0.842, 95% confidence interval(CI) 0.722-0.981, P = 0.027], meeting the prespecified boundary for significance.

在意向治疗人群中，中位随访时间为76.2个月，abemaciclib-ET组的死亡风险比ET组低15.8% [661例死亡；风险比0.842，95%置信区间（CI）0.722-0.981，P = 0.027]，达到了预设的显著性边界。

The 7-year OS was 86.8% with abemaciclib-ET and 85.0% with ET (absolute difference, 1.8%).

接受阿贝西利联合内分泌治疗（abemaciclib-ET）的患者7年总生存率为86.8%，而仅接受内分泌治疗（ET）的患者为85.0%（绝对差异，1.8%）。

OS benefit was consistent across prespecified subgroups.

总生存获益在预先指定的亚组中是一致的。

In addition to patients who had already died of metastatic disease, fewer patients in the abemaciclib-ET arm were living with metastatic disease compared with the ET arm (6.4% versus 9.4%).

除了那些已经因转移性疾病死亡的患者外，接受阿贝西利联合内分泌治疗（abemaciclib-ET）的患者中，带瘤生存的患者比例低于仅接受内分泌治疗（ET）的患者（6.4%对比9.4%）。

Sustained improvement was demonstrated in IDFS and DRFS (hazard ratio0.734, 95% CI 0.657-0.820 and hazard ratio0.746, 95% CI 0.662-0.840, respectively).

在无侵袭性疾病生存（IDFS）和无远处复发生存（DRFS）方面显示出持续的改善（风险比分别为0.734，95%置信区间0.657-0.820和风险比0.746，95%置信区间0.662-0.840）。

Seven-year IDFS was 77.4% with abemaciclib-ET and 70.9% with ET (absolute difference, 6.5%) and 7-year DRFS were 80.0% and 74.9% (absolute difference, 5.1%).

七年的无侵袭性疾病生存期（IDFS）在接受阿贝西利联合内分泌治疗（abemaciclib-ET）的患者中为77.4%，而仅接受内分泌治疗（ET）的患者为70.9%（绝对差异，6.5%）。七年的无远处复发生存期（DRFS）分别为80.0%和74.9%（绝对差异，5.1%）。

The long-term safety data compiled did not support any concerns of delayed toxicities.

汇总的长期安全性数据并未支持有关延迟性毒性的任何担忧。

Conclusions

Adjuvant abemaciclib-ET resulted in a statistically significant and clinically meaningful improvement in OS compared with ET in patients with HR-positive, HER2-negative, node-positive, high-risk EBC.

辅助性阿贝西利联合内分泌治疗（abemaciclib-ET）在HR阳性、HER2阴性、淋巴结阳性、高风险早期乳腺癌（EBC）患者中，与单纯内分泌治疗（ET）相比，总生存（OS）有统计学意义和临床意义的显著改善。

At 7 years, abemaciclib-ET continued to demonstrate a sustained IDFS and DRFS benefit.

在7年时，阿贝西利-ET继续显示出持续的无侵袭性疾病生存（IDFS）和无远处复发生存（DRFS）的益处。