Li Jian-Wei, Mo Miao, Yu Ke-da, Chen Can-Ming, Hu Zhen, Hou Yi-Feng, Di Gen-Hong, Wu Jiong, Shen Zhen-Zhou, Shao Zhi-Ming, Liu Guang-Yu
Department of Breast Surgery, Shanghai Cancer Center/Cancer Institute, Fudan University, Shanghai, P. R. China and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P. R. China.
Clinical Statistics Center, Fudan University Shanghai Cancer Center, Shanghai, P. R. China and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P. R. China.
PLoS One. 2014 Dec 11;9(12):e114646. doi: 10.1371/journal.pone.0114646. eCollection 2014.
The study was to estimate the likelihood of axillary downstaging and to identify the factors predicting a pathologically node negative status after neoadjuvant chemotherapy (NAC) with or without trastuzumab in HER2-positive breast cancer.
Patients with HER2-positive, stage IIa-IIIc breast cancer were enrolled. Axillary status was evaluated by palpation and fine needle aspiration (FNA) before NAC. All patients received 4-6 cycles of PCrb (paclitaxel 80 mg/m2 and carboplatin AUC = 2 d1, 8, and 15 of a 28-day cycle, or paclitaxel 175 mg/m2 and carboplatin AUC = 6 every-3-week) and were non-randomly administered trastuzumab (2 mg/kg weekly or 6 mg/kg every-3-week) or not. After NAC, each patient underwent standard axillary lymph node dissection and breast-conserving surgery or mastectomy. And some patients received sentinel lymph node biopsy (SLNB) before axillary dissection.
Between November-2007 and June-2013, 255 patients were enrolled. Of them, 157 were confirmed as axillary node positive by FNA (group-A) and 98 as axillary node negative either by FNA or impalpable (group-B). After axillary dissection, the overall pathologically node negative rates (pNNR) were 52.9% in group-A and 69.4% in group-B. The ER-poor/HER2-positive subtype acquired the highest pNNR (79.6% in group-A and 87.9% in group-B, respectively) and the lowest rate of residual with ≥4 nodes involvement (1.9% and 3%, respectively) after PCrb plus trastuzumab. In multivariate analysis, trastuzumab added and ER-poor status were independent factors in predicting a higher pNNR in HER2-positive breast cancer. Forty-six tested patients showed that the ER-poor/HER2-positive subtype acquired a considerable high pNNR and axillary status with SLNB was well macthed with the axillary dissection.
ER-poor/HER2-positive subtype of breast cancer is a potential candidate for undergoing sentinel lymph node biopsy instead of regional node dissection for accurate axillary evaluation after effective downstaging by neoadjuvant chemo-trastuzumab therapy.
本研究旨在评估腋窝降期的可能性，并确定在HER2阳性乳腺癌中接受或不接受曲妥珠单抗新辅助化疗（NAC）后预测病理淋巴结阴性状态的因素。
纳入HER2阳性、IIa-IIIc期乳腺癌患者。在NAC前通过触诊和细针穿刺抽吸（FNA）评估腋窝状态。所有患者接受4-6周期的PCrb方案（紫杉醇80mg/m²和卡铂AUC=2，第1、8、15天，28天为一个周期；或紫杉醇175mg/m²和卡铂AUC=6，每3周一次），并非随机给予曲妥珠单抗（每周2mg/kg或每3周6mg/kg）或不给予。NAC后，每位患者接受标准腋窝淋巴结清扫及保乳手术或乳房切除术。部分患者在腋窝清扫前行前哨淋巴结活检（SLNB）。
2007年11月至2013年6月，共纳入255例患者。其中，157例经FNA确诊为腋窝淋巴结阳性（A组），98例经FNA或触诊未触及确诊为腋窝淋巴结阴性（B组）。腋窝清扫后，A组的总体病理淋巴结阴性率（pNNR）为52.9%，B组为69.4%。ER低表达/HER2阳性亚型在接受PCrb加曲妥珠单抗治疗后获得最高的pNNR（A组为79.6%，B组为87.9%）以及最低的≥4个淋巴结受累残留率（分别为1.9%和3%）。多因素分析显示，加用曲妥珠单抗和ER低表达状态是预测HER2阳性乳腺癌更高pNNR的独立因素。46例接受检测的患者显示，ER低表达/HER2阳性亚型获得相当高的pNNR，且SLNB的腋窝状态与腋窝清扫结果匹配良好。
ER低表达/HER2阳性亚型乳腺癌在经新辅助化疗-曲妥珠单抗治疗有效降期后，是进行前哨淋巴结活检而非区域淋巴结清扫以准确评估腋窝的潜在候选对象。
