Department of Breast Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, 277 West Yanta Road, 710061, Xi'an, People's Republic of China.
Department of Cancer Epidemiology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.
Diagn Pathol. 2019 May 4;14(1):35. doi: 10.1186/s13000-019-0806-4.
The concordance rate of human epidermal growth factor receptor 2 (HER2) status between core needle biopsy (CNB) and subsequent excisional biopsies of the same tumor varies from 81 to 96%, which may cause inappropriate neoadjuvant therapy that impair the potential benefit from HER2 targeted therapy for patients. This study aimed to establish a nomogram to predict the HER2 status pre-operatively as an auxiliary diagnosis to CNB assessment.
Among 4211 breast cancer patients cataloged in the Nation-wide Multicenter 10-year Retrospective Clinical Epidemiological Study of Breast Cancer in China, 2291 patients with complete relevant information were included in this study, which were further randomized 3:1 and divided into a training set and a validation set. The nomogram was established based on independent predictors of HER2 positivity recognized by logistic regression analysis and further validated internally and externally.
The multivariate logistic regression analysis showed that T-stage, N-stage, estrogen receptor (ER) status, progesterone receptor (PR) status were independent predictors for HER2 status. The nomogram was thereby constructed by those independent predictors as well as histology type. The areas under the receiver operating characteristic curve (AUC) of the training set and the validation set were 0.636 and 0.681, respectively. The calibration plots demonstrated good fitness of the nomogram for HER2 status prediction. With the optimal cutoff value, the nomogram yielded 80.0% sensitivity, 43.1% specificity in the training set and 81.1% sensitivity, 49.8% specificity in the validation set.
The present nomogram can provide valuable information on HER2 status and combined with standard CNB assessment, clinicians could make more appropriate decision on neoadjuvant therapy of breast cancer.
核心针活检 (CNB) 与同一肿瘤后续切除活检的人表皮生长因子受体 2 (HER2) 状态一致性率为 81%至 96%,这可能导致新辅助治疗不当,从而损害 HER2 靶向治疗对患者的潜在获益。本研究旨在建立一个术前预测 HER2 状态的列线图,作为 CNB 评估的辅助诊断。
在中国全国多中心 10 年乳腺癌回顾性临床流行病学研究中,共纳入 4211 例乳腺癌患者,其中 2291 例患者具有完整的相关信息,进一步将其随机分为 3:1 分为训练集和验证集。该列线图基于逻辑回归分析识别的 HER2 阳性的独立预测因子建立,并在内部和外部进行进一步验证。
多变量逻辑回归分析显示 T 分期、N 分期、雌激素受体 (ER) 状态、孕激素受体 (PR) 状态是 HER2 状态的独立预测因子。因此,该列线图由这些独立预测因子以及组织学类型构建而成。训练集和验证集的受试者工作特征曲线 (AUC) 下面积分别为 0.636 和 0.681。校准图表明该列线图对 HER2 状态预测具有良好的拟合度。在最佳截断值下,该列线图在训练集中的灵敏度为 80.0%,特异性为 43.1%,在验证集中的灵敏度为 81.1%,特异性为 49.8%。
本列线图可以提供有关 HER2 状态的有价值信息,并结合标准 CNB 评估,临床医生可以对乳腺癌的新辅助治疗做出更恰当的决策。