激素受体阳性、HER2 阴性转移性乳腺癌患者引入细胞周期蛋白依赖性激酶 4/6 抑制剂后总生存的种族差异。
Racial disparities in overall survival after the introduction of cyclin-dependent kinase 4/6 inhibitors for patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
机构信息
Department of Medicine, Hematology/Oncology, Carole and Ray Neag Comprehensive Cancer Center, UCONN Health, Farmington, CT, USA.
Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, 1695 Eastchester Rd, Bronx, NY, 10461, USA.
出版信息
Breast Cancer Res Treat. 2023 Feb;198(1):75-88. doi: 10.1007/s10549-022-06847-2. Epub 2022 Dec 23.
PURPOSE
CDK4/6 inhibitors (CDK4/6i) combined with endocrine therapy have improved HR + /HER2- metastatic breast cancer (MBC) outcomes. However, it is still unclear whether the response to CDK4/6i is similar for all races. Therefore, we aimed to assess overall survival (OS) trends stratified by race in patients with HR + /HER2- MBC after the approval of CDK4/6i, as part of the standard of care, in 2015.
METHODS
We performed a population-based study using the SEER database. Patients with HR + /HER2- MBC were divided into two time-based cohorts: 1) pre-CDK4/6i era (diagnosed in 2011-2013) and 2) post-CDK4/6i era (diagnosed in 2015-2017). We used propensity score matching and identified 2,684 patients in each cohort that matched in several characteristics. Kaplan-Meier methods were used to estimate 2-year OS. Association between cohort and OS was evaluated using marginal Cox proportional hazards models with robust sandwich variance estimator. We conducted competing risk analysis to estimate the risk of breast cancer death in both cohorts.
RESULTS
The 2-year OS rate was 65% for the post-CDK4/6i era and 62% for the pre-CDK4/6i era (stratified log-rank p = 0.025). The 2-year OS for non-Hispanic White (NHW) patients improved in the post-CDK4/6i era compared to the pre-CDK4/6i era (67% vs. 63%, p = 0.033). However, OS did not improve for non-Hispanic Black (NHB) (54% vs. 54%, p = 0.876) or Hispanic (67% vs. 65%, p = 0.617) groups. The risk of breast cancer death decreased in the post-CDK4/6i era as compared to the pre-CDK4/6i era (2-year risk of breast cancer death: 33% vs. 30%, p = 0.015); however, this effect was observed only in NHW (sHR 0.84, p = 0.005) women, but not in NHB (sHR 0.94, p = 0.630) or Hispanic (sHR 0.91, p = 0.550) women.
CONCLUSIONS
Our study confirms that outcomes for HR + /HER2- MBC have improved after CDK4/6i were introduced in 2015. However, this effect is primarily driven by the improved OS in NHW patients, without significant improvement in OS in NHB or Hispanics.
目的
CDK4/6 抑制剂（CDK4/6i）联合内分泌治疗改善了 HR+/HER2-转移性乳腺癌（MBC）的预后。然而，CDK4/6i 对所有种族的反应是否相似仍不清楚。因此，我们旨在评估 2015 年 CDK4/6i 被批准为标准治疗后 HR+/HER2-MBC 患者的种族分层总生存（OS）趋势。
方法
我们使用 SEER 数据库进行了一项基于人群的研究。将 HR+/HER2-MBC 患者分为两个基于时间的队列：1）CDK4/6i 前时代（2011-2013 年诊断）和 2）CDK4/6i 后时代（2015-2017 年诊断）。我们使用倾向评分匹配，在每个队列中匹配了 2684 名具有多种特征的患者。使用 Kaplan-Meier 方法估计 2 年 OS。使用具有稳健 sandwich 方差估计的边缘 Cox 比例风险模型评估队列与 OS 的关联。我们进行竞争风险分析，以估计两个队列中乳腺癌死亡的风险。
结果
CDK4/6i 后时代的 2 年 OS 率为 65%，CDK4/6i 前时代为 62%（分层对数秩 p=0.025）。与 CDK4/6i 前时代相比，非西班牙裔白人（NHW）患者的 2 年 OS 在 CDK4/6i 后时代有所改善（67% vs. 63%，p=0.033）。然而，非西班牙裔黑人（NHB）（54% vs. 54%，p=0.876）或西班牙裔（67% vs. 65%，p=0.617）组的 OS 并未改善。与 CDK4/6i 前时代相比，CDK4/6i 后时代乳腺癌死亡的风险降低（2 年乳腺癌死亡风险：33% vs. 30%，p=0.015）；然而，这种影响仅在 NHW（sHR 0.84，p=0.005）女性中观察到，而在 NHB（sHR 0.94，p=0.630）或西班牙裔（sHR 0.91，p=0.550）女性中未观察到。
结论
我们的研究证实，2015 年 CDK4/6i 引入后，HR+/HER2-MBC 的预后得到了改善。然而，这种影响主要是由 NHW 患者的 OS 改善驱动的，而 NHB 或西班牙裔患者的 OS 改善并不明显。
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