Objectives: To examine the clinicopathological characteristics and the influencing factors of the residual tumor of patients with Breast Image Report and Data System (BI-RADS) grade 3 lesions diagnosed with malignancy after minimally invasive excision. Methods: In this retrospective case-control study, clinicopathological data of 69 cases, which had been evaluated as BI-RADS 3 lesions by ultrasound (4 151 cases) diagnosed with breast cancer by minimally invasive excision pathology, were analyzed between May 2012 and June 2016 at the Department of Breast Surgery of the Second Hospital of Shandong University and Linyi People's Hospital. All patients were female, aged (43.4±8.2) years (range: 22 to 70 years). Based on residual tumor after minimally invasive excision, patients were classified into two subgroups: tumor residual group (n=39) and non-tumor residual group (n=30). The clinicopathological features between the two groups were compared. The differences in clinicopathological characteristics were compared in different groups using the χ2 test and the t test. Potential variables identified in the univariate analysis and other relevant variables will be analyzed multivarially using Logistic regression models. The Kaplan-Meier method was applied for survival analysis and survival curves. Results: The breast cancer detection rate of ultrasound BI-RADS 3 lesions was 1.66% (69/4 151), and their maximum diameter of the masses was (1.27±0.45) cm (range: 0.5 to 2.3 cm). Among them, the maximum diameter were ≤1 cm in 28 cases and >1 cm in 41 cases. Histopathological results showed carcinoma in situ in 24 cases and invasive carcinoma in 41 cases, positive expression of the estrogen receptor in 47 cases, positive expression of the progesterone receptor in 43 cases, Ki-67 proliferation index elevated in 26 cases. Axillary metastasis positive rate was 10.1% (7/69). Residual tumor after minimally invasive surgery was found in 39 cases (56.5%). Univariate analysis showed that the tumour residual group showed a significantly increased rate of positive expression of the estrogen receptor (91.9%(34/37) vs. 61.9%(13/21), χ2=7.838, P=0.012). In multivariate analysis, the only variable found to significantly affect the residual tumor was the positive expression of the estrogen receptor (OR=16.852, 95%CI: 1.819 to 156.130, P=0.013). The 5-year disease-free survival rate of breast cancer patients with breast ultrasound BI-RADS 3 lesions was 97.1% and the overall survival rate was 98.6%. Conclusions: BI-RADS 3 lesions diagnosed by ultrasound undergoing ultrasound-guided minimally invasive excision have a certain risk of detected malignancy, approximately 1.66%. Patients with positive expression of the estrogen receptor are more likely to develop residual tumor. A secondary operation should be considered to ensure that no tumor residues remain in the cavity.
目的： 探讨超声下乳腺影像报告和数据系统（BI-RADS）3类结节微创旋切术后确诊乳腺癌患者的临床病理学特征及肿瘤残留的影响因素。 方法： 本研究为回顾性病例对照研究。回顾性收集2012年5月至2016年6月就诊于山东大学第二医院乳腺外科、临沂市人民医院乳腺外科的4 151例乳腺超声BI-RADS 3类结节微创旋切术中确诊乳腺癌的69例患者的临床病理学资料，患者均为女性，年龄（43.4±8.2）岁（范围：22~70岁）。根据微创旋切术后有无肿瘤残留分为残留组和无残留组，采用χ2检验、独立样本t检验比较两组患者的临床病理学资料。采用Logistic回归分析肿瘤残留的影响因素，应用Kaplan-Meier法进行生存分析并绘制生存曲线。 结果： 乳腺超声BI-RADS 3类结节微创旋切术后确诊乳腺癌的患者占同时期该类患者的1.66%（69/4 151）。其肿物最大径为（1.27±0.45）cm（范围：0.5~2.3 cm），28例肿物最大径≤1 cm，41例肿物最大径>1 cm，组织病理学结果为原位癌24例，浸润性癌41例，雌激素受体阳性47例，孕激素受体阳性43例，Ki-67指数升高26例。腋窝转移阳性率10.1%（7/69）。39例患者存在肿瘤残留，占乳腺癌患者的56.5%（39/69）。单因素分析结果显示，残留组雌激素受体阳性比例更高［91.9%（34/37）比61.9%（13/21），χ2=7.838，P=0.012］。多因素分析结果显示，雌激素受体阳性（OR=16.852，95%CI：1.819~156.130，P=0.013）为术后肿瘤残留的独立影响因素。乳腺超声BI-RADS 3类结节乳腺癌患者5年无病生存率为97.1%，总体生存率为98.6%。 结论： 可用微创旋切术处理的BI-RADS 3 类结节具有一定恶性风险，约为 1.66%。雌激素受体阳性的患者更易发生肿瘤残留。微创旋切术后存在一定的肿瘤残留，对确诊为乳腺癌患者，需进行二次手术确保残腔无肿瘤残留。.