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中国(中华医学会外科学分会乳腺外科学组 021)低表达人表皮生长因子受体 2 的早期乳腺癌临床病理特征及复发风险预测模型的多中心研究。

Multicenter study of the clinicopathological features and recurrence risk prediction model of early-stage breast cancer with low-positive human epidermal growth factor receptor 2 expression in China (Chinese Society of Breast Surgery 021).

机构信息

Breast Disease Center, 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). 2022 Mar 20;135(6):697-706. doi: 10.1097/CM9.0000000000002056.

Abstract

BACKGROUND

: Breast cancer with low-positive human epidermal growth factor receptor 2 (HER2) expression has triggered further refinement of evaluation criteria for HER2 expression. We studied the clinicopathological features of early-stage breast cancer with low-positive HER2 expression in China and analyzed prognostic factors.

METHODS

: Clinical and pathological data and prognostic information of patients with early-stage breast cancer with low-positive HER2 expression treated by the member units of the Chinese Society of Breast Surgery and Chinese Society of Surgery of Chinese Medical Association, from January 2015 to December 2016 were collected. The prognostic factors of these patients were analyzed.

RESULTS

: Twenty-nine hospitals provided valid cases. From 2015 to 2016, a total of 25,096 cases of early-stage breast cancer were treated, 7642 (30.5%) of which had low-positive HER2 expression and were included in the study. After ineligible cases were excluded, 6486 patients were included in the study. The median follow-up time was 57 months (4-76 months). The disease-free survival rate was 92.1% at 5 years, and the overall survival rate was 97.4% at 5 years. At the follow-up, 506 (7.8%) cases of metastasis and 167 (2.6%) deaths were noted. Multivariate Cox regression analysis showed that tumor stage, lymphvascular invasion, and the Ki67 index were related to recurrence and metastasis (P < 0.05). The recurrence risk prediction model was established using a machine learning model and showed that the area under the receiving operator characteristic curve was 0.815 (95% confidence interval: 0.750-0.880).

CONCLUSIONS

: Early-stage breast cancer patients with low-positive HER2 expression account for 30.5% of all patients. Tumor stage, lymphvascular invasion, and the Ki67 index are factors affecting prognosis. The recurrence prediction model for breast cancer with low-positive HER2 expression based on a machine learning model had a good clinical reference value for predicting the recurrence risk at 5 years.

TRIAL REGISTRATION

: ChiCTR.org.cn, ChiCTR2100046766.

摘要

背景

具有低阳性人表皮生长因子受体 2(HER2)表达的乳腺癌引发了对 HER2 表达评估标准的进一步细化。我们研究了中国早期 HER2 低阳性乳腺癌的临床病理特征,并分析了预后因素。

方法

收集中国抗癌协会乳腺癌专业委员会和中国医师协会外科医师分会成员单位 2015 年 1 月至 2016 年 12 月收治的早期 HER2 低阳性乳腺癌患者的临床病理资料和预后信息,分析患者的预后因素。

结果

29 家医院提供了有效病例。2015 年至 2016 年,共治疗了 25096 例早期乳腺癌患者,其中 7642 例(30.5%)HER2 低阳性,纳入研究。排除不合格病例后,纳入 6486 例患者进行研究。中位随访时间为 57 个月(4-76 个月)。5 年无病生存率为 92.1%,5 年总生存率为 97.4%。随访时,506 例(7.8%)发生转移,167 例(2.6%)死亡。多因素 Cox 回归分析显示,肿瘤分期、脉管侵犯和 Ki67 指数与复发转移相关(P<0.05)。使用机器学习模型建立了复发风险预测模型,其接受者操作特征曲线下面积为 0.815(95%置信区间:0.750-0.880)。

结论

早期 HER2 低阳性乳腺癌患者占所有患者的 30.5%。肿瘤分期、脉管侵犯和 Ki67 指数是影响预后的因素。基于机器学习模型的 HER2 低阳性乳腺癌复发预测模型对预测 5 年复发风险具有良好的临床参考价值。

临床试验注册

ChiCTR.org.cn,ChiCTR2100046766。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a0b/9276244/336cf63c34be/cm9-135-697-g001.jpg

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