一项多中心研究，探讨激素受体阳性/人表皮生长因子受体 2 低表达早期乳腺癌的临床病理特征和风险预测模型。

A multicenter study of the clinicopathological characteristics and a risk prediction model of early-stage breast cancer with hormone receptor-positive/human epidermal growth factor receptor 2-low expression.

机构信息

Department of Breast and Thyroid, Peking University First Hospital, Beijing 100034, China.

Jun Yi Tai He Medical Technology Co. Ltd., Beijing 100024, China.

出版信息

Chin Med J (Engl). 2023 Dec 20;136(24):2967-2973. doi: 10.1097/CM9.0000000000002831. Epub 2023 Oct 11.

DOI:10.1097/CM9.0000000000002831

PMID:37822006

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10752477/

Abstract

BACKGROUND

In light of the significant clinical benefits of antibody-drug conjugates in clinical trials, the human epidermal growth factor receptor 2 (HER2)-low category in breast cancers has gained increasing attention. Therefore, we studied the clinicopathological characteristics of Chinese patients with hormone receptor (HR)-positive/HER2-low early-stage breast cancer and developed a recurrence risk prediction model.

METHODS

Female patients with HR-positive/HER2-low early-stage breast cancer treated in 29 hospitals of the Chinese Society of Breast Surgery (CSBrS) from Jan 2015 to Dec 2016 were enrolled. Their clinicopathological data and prognostic information were collected, and machine learning methods were used to analyze the prognostic factors.

RESULTS

In total, 25,096 patients were diagnosed with breast cancer in 29 hospitals of CSBrS from Jan 2015 to Dec 2016, and clinicopathological data for 6486 patients with HER2-low early-stage breast cancer were collected. Among them, 5629 patients (86.79%) were HR-positive. The median follow-up time was 57 months (4, 76 months); the 5-year disease-free survival (DFS) rate was 92.7%, and the 5-year overall survival (OS) rate was 97.7%. In total, 412 cases (7.31%) of metastasis were observed, and 124 (2.20%) patients died. Multivariate Cox regression analysis revealed that T stage, N stage, lymphovascular thrombosis, Ki-67 index, and prognostic stage were associated with recurrence and metastasis ( P <0.05). A recurrence risk prediction model was established using the random forest method and exhibited a sensitivity of 81.1%, specificity of 71.7%, positive predictive value of 74.1%, and negative predictive value of 79.2%.

CONCLUSION

Most of patients with HER2-low early-stage breast cancer were HR-positive, and patients had favorable outcome; tumor N stage, lymphovascular thrombosis, Ki-67 index, and tumor prognostic stage were prognostic factors. The HR-positive/HER2-low early-stage breast cancer recurrence prediction model established based on the random forest method has a good reference value for predicting 5-year recurrence events.

REGISTRITATION

ChiCTR.org.cn, ChiCTR2100046766.

摘要

背景

鉴于抗体药物偶联物在临床试验中的显著临床获益，乳腺癌中的人表皮生长因子受体 2（HER2）低表达类别受到越来越多的关注。因此，我们研究了中国激素受体（HR）阳性/HER2 低表达早期乳腺癌患者的临床病理特征，并建立了复发风险预测模型。

方法

纳入 2015 年 1 月至 2016 年 12 月期间中国抗癌协会乳腺癌专业委员会（CSBrS）29 家医院治疗的 HR 阳性/HER2 低表达早期乳腺癌女性患者。收集其临床病理数据和预后信息，并采用机器学习方法分析预后因素。

结果

2015 年 1 月至 2016 年 12 月期间，CSBrS 29 家医院共诊断出 25096 例乳腺癌患者，其中收集了 6486 例 HER2 低表达早期乳腺癌患者的临床病理数据。其中，5629 例（86.79%）为 HR 阳性。中位随访时间为 57 个月（4~76 个月）；5 年无病生存率（DFS）为 92.7%，5 年总生存率（OS）为 97.7%。共观察到 412 例（7.31%）转移病例，124 例（2.20%）患者死亡。多因素 Cox 回归分析显示，T 分期、N 分期、脉管瘤栓、Ki-67 指数和预后分期与复发转移有关（P<0.05）。采用随机森林法建立了复发风险预测模型，其敏感性为 81.1%，特异性为 71.7%，阳性预测值为 74.1%，阴性预测值为 79.2%。