Department of Clinical Science and Education, Karolinska Institutet, Southern General Hospital Stockholm, Sweden.
Department of Surgery, Breast Unit, Capio St Göran's Hospital, Stockholm, Sweden.
Br J Surg. 2021 May 27;108(5):583-589. doi: 10.1002/bjs.11963.
This follow-up analysis of a Swedish prospective multicentre trial had the primary aim to determine invasive disease-free (IDFS), breast cancer-specific (BCSS) and overall survival (OS) rates, and their association with axillary staging results before and after neoadjuvant systemic therapy for breast cancer.
Women who underwent neoadjuvant systemic therapy for clinically node-positive (cN+) or -negative (cN0) primary breast cancer between 2010 and 2015 were included. Patients had a sentinel lymph node biopsy before and/or after neoadjuvant systemic therapy, and all underwent completion axillary lymph node dissection. Follow-up was until February 2019. The main outcome measures were IDFS, BCSS and OS. Univariable and multivariable Cox regression analyses were used to identify independent factors associated with survival.
The study included a total of 417 women. Median follow-up was 48 (range 7-114) months. Nodal status after neoadjuvant systemic therapy, but not before, was significantly associated with crude survival: residual nodal disease (ypN+) resulted in a significantly shorter 5-year OS compared with a complete nodal response (ypN0) (83·3 versus 91·0 per cent; P = 0·017). The agreement between breast (ypT) and nodal (ypN) status after neoadjuvant systemic therapy was high, and more so in patients with cN0 tumours (64 of 66, 97 per cent) than those with cN+ disease (49 of 60, 82 per cent) (P = 0·005). In multivariable analysis, ypN0 (hazard ratio 0·41, 95 per cent c.i. 0·22 to 0·74; P = 0·003) and local radiotherapy (hazard ratio 0·23, 0·08 to 0·64; P = 0·005) were associated with improved IDFS, and triple-negative molecular subtype with worse IDFS.
The present findings underline the prognostic significance of nodal status after neoadjuvant systemic therapy. This confirms the clinical value of surgical axillary staging after neoadjuvant systemic therapy.
本研究是对瑞典一项前瞻性多中心试验的随访分析，主要目的是确定新辅助全身治疗前后乳腺癌浸润性无病生存（IDFS）、乳腺癌特异性生存（BCSS）和总生存（OS）率及其与腋窝分期结果的关系。
本研究纳入了 2010 年至 2015 年间接受新辅助全身治疗的临床淋巴结阳性（cN+）或阴性（cN0）原发性乳腺癌患者。所有患者在新辅助全身治疗前后均行前哨淋巴结活检，并均接受了完整的腋窝淋巴结清扫术。随访至 2019 年 2 月。主要观察终点为 IDFS、BCSS 和 OS。采用单变量和多变量 Cox 回归分析确定与生存相关的独立因素。
本研究共纳入 417 例患者。中位随访时间为 48 个月（范围 7-114 个月）。新辅助全身治疗后的淋巴结状态，而非治疗前的淋巴结状态，与粗生存率显著相关：残留淋巴结疾病（ypN+）患者的 5 年 OS 显著短于完全淋巴结缓解（ypN0）患者（83.3%比 91.0%；P=0.017）。新辅助全身治疗后乳腺（ypT）和淋巴结（ypN）状态的一致性较高，在 cN0 肿瘤患者中更明显（66 例中的 64 例，97%），而在 cN+疾病患者中则不明显（60 例中的 49 例，82%）（P=0.005）。多变量分析显示，ypN0（风险比 0.41，95%置信区间 0.22-0.74；P=0.003）和局部放疗（风险比 0.23，0.08-0.64；P=0.005）与 IDFS 改善相关，三阴性分子亚型与 IDFS 较差相关。
本研究结果强调了新辅助全身治疗后淋巴结状态的预后意义。这证实了新辅助全身治疗后行外科腋窝分期的临床价值。
