Shi Zhiqiang, Wang Xueer, Qiu Pengfei, Liu Yanbing, Zhao Tong, Sun Xiao, Chen Peng, Wang Chunjian, Zhang Zhaopeng, Cong Binbin, Wang Yongsheng
Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, China.
Department of Radiotherapy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, China.
Gland Surg. 2021 Jan;10(1):166-174. doi: 10.21037/gs-20-573.
With the improvement of the efficacy of neoadjuvant therapy (NAT) that is guided by molecular subtypes, the rate of pathologically node-negative disease after NAT (ypN0) is increasing for HER2 positive (HER2+) and triple-negative (TN) breast cancer patients. The necessity of axillary surgery for patients with high ypN0 has been questioned. This study aimed to identify patients among HER2+ and TN breast cancer with low risk for axillary metastases after NAT, and, perhaps, they are suitable for selective elimination of axillary surgery staging.
From January 2010 to August 2018, 865 breast cancer patients who underwent NAT were included in this retrospective clinical study, and 184 patients (21.3%,184/865) suffered from TN and HER2+ breast cancer and received full-course NAT. The correlation among clinicopathological characteristics of HER2+ and TN breast cancer and ypN0 were analyzed.
Among the 184 HER2+ and TN breast cancer patients, tumor staging, lymph node staging and Ki-67 before NAT, clinically node-negative disease after NAT (ycN0), and breast radiologic and pathologic complete response (bpCR) were correlated with ypN0 (P<0.05). Lymph node staging before NAT (OR =0.363, P<0.001), ycN0 (OR =4.995, P<0.001) and bpCR (OR =11.285, P<0.001) were the independent effects of ypN0. The ypN0 rate after NAT in cN0/1 patients with bpCR and ycN0 (97.6%, 40/41) was significantly higher than that in cN2/3 patients (62.5%, 10/16) (P<0.001). Among the 37 patients with initial nodal ultrasonography showing cN0 disease, 17 of 17 (100.0%) with and 18 of 20 (90.0%) without bpCR had no evidence of residual nodal disease (P=0.178). Among the 42 patients with cN1 to ycN0, 23 of 24 (95.8%) with and 10 of 18 (55.6%) without bpCR had no evidence of residual nodal disease (P<0.001). Patients without bpCR had a relative risk for nodal residual metastases of 10.560 (95% CI: 2.720-41.003; P<0.001) compared with those with bpCR in cN1 group.
In terms of HER2+ and TN breast cancer patients, clinical lymph node staging before NAT, ycN0 and bpCR were the independent predictors of ypN0. bpCR was highly correlated with nodal status after NAT. The risk of axillary lymph nodes residual metastases after NAT in the patients of bpCR with cN0 and cN1 to ycN0 was less than 5%, thus making it possible to selectively avoid axillary surgery.
随着以分子亚型为指导的新辅助治疗（NAT）疗效的提高，NAT后HER2阳性（HER2+）和三阴性（TN）乳腺癌患者病理淋巴结阴性疾病（ypN0）的发生率正在增加。NAT后ypN0高的患者进行腋窝手术的必要性受到质疑。本研究旨在确定HER2+和TN乳腺癌患者中NAT后腋窝转移风险低的患者，或许他们适合选择性免除腋窝手术分期。
2010年1月至2018年8月，865例行NAT的乳腺癌患者纳入本回顾性临床研究，184例（21.3%，184/865）患TN和HER2+乳腺癌并接受全程NAT。分析HER2+和TN乳腺癌的临床病理特征与ypN0之间的相关性。
在184例HER2+和TN乳腺癌患者中，NAT前的肿瘤分期、淋巴结分期和Ki-67、NAT后临床淋巴结阴性疾病（ycN0）以及乳腺放射学和病理完全缓解（bpCR）与ypN0相关（P<0.05）。NAT前的淋巴结分期（OR =0.363，P<0.001）、ycN0（OR =4.995，P<0.001）和bpCR（OR =11.285，P<0.001）是ypN0的独立影响因素。bpCR且ycN0的cN0/1患者NAT后的ypN0率（97.6%，40/41）显著高于cN2/3患者（62.5%，10/16）（P<0.001）。在37例初始淋巴结超声显示cN0疾病的患者中，有bpCR的17例（100.0%）和无bpCR的20例中的18例（90.0%）均无残留淋巴结疾病证据（P=0.178）。在从cN1转为ycN0的42例患者中，有bpCR的24例中的23例（9５.8%）和无bpCR的18例中的10例（55.6%）均无残留淋巴结疾病证据（P<0.001）。与cN1组中有bpCR的患者相比，无bpCR的患者发生淋巴结残留转移的相对风险为10.560（95%CI：2.720-41.003；P<0.001）。
对于HER2+和TN乳腺癌患者，NAT前的临床淋巴结分期、ycN0和bpCR是ypN0的独立预测因素。bpCR与NAT后的淋巴结状态高度相关。bpCR且cN0以及cN1转为ycN0的患者NAT后腋窝淋巴结残留转移风险小于5%，因此有可能选择性避免腋窝手术。
