Division of Breast Surgery, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Division of Radiation Oncology, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Breast J. 2020 Jul;26(7):1330-1336. doi: 10.1111/tbj.13851. Epub 2020 Jun 7.
The purpose of this study is the evaluation of clinical and surgical impact of the Z0011 trial criteria on the management of breast cancer (BC) patients undergoing breast conservative surgery (BCS) at the European Institute of Oncology (IEO). We studied 1386 patients who underwent BCS and sentinel lymph node biopsy (SLNB) from July 2016 to July 2018. Clinical evaluation, breast ultrasound, mammogram, and cyto/histological examination were performed for all patients at the time of diagnosis. Frozen sections of the sentinel lymph node (SLN) were not performed for any patient. Patients who underwent neo-adjuvant therapy were excluded. To evaluate the results before and after the introduction of Z0011 criteria, a group of 1425 patients with the same characteristics who underwent BCS and SLNB from July 2013 to July 2015 were analyzed. We studied the characteristics of the patients by nodal status, and we observed that T stage, tumor grade, and lymphovascular invasion were statistically related with the highest rate of positive SLN. Of the 1386 patients who underwent surgery after the introduction of the Z011 trial, 1156 patients (83.4%) had negative SLN, 230 patients (16.6%) had positive SLN. Subsequent axillary lymph node dissection (ALND) was performed in only 7 cases (3.0%). Of the 1425 patients operated before the introduction of the Z0011 trial, 216 patients had subsequent ALND (15%). The reduction in the number of ALND performed after the introduction of Z0011 is statistically significant, and this could result in a remarkable reduction of the comorbidities of our patients.
本研究的目的是评估 Z0011 试验标准对欧洲肿瘤研究所（IEO）行保乳手术（BCS）的乳腺癌（BC）患者的临床和手术影响。我们研究了 1386 例于 2016 年 7 月至 2018 年 7 月期间行 BCS 和前哨淋巴结活检（SLNB）的患者。所有患者在诊断时均行临床评估、乳腺超声、乳房 X 线摄影和细胞/组织学检查。未对任何患者行 SLN 冷冻切片检查。排除接受新辅助治疗的患者。为评估引入 Z0011 标准前后的结果，我们分析了一组具有相同特征、于 2013 年 7 月至 2015 年 7 月期间行 BCS 和 SLNB 的 1425 例患者。我们根据淋巴结状态研究了患者的特征，观察到 T 分期、肿瘤分级和脉管侵犯与 SLN 阳性率最高具有统计学相关性。在引入 Z011 试验后行手术的 1386 例患者中，1156 例（83.4%）SLN 阴性，230 例（16.6%）SLN 阳性。仅 7 例（3.0%）行后续腋窝淋巴结清扫术（ALND）。在引入 Z0011 试验前手术的 1425 例患者中，216 例（15%）行后续 ALND。引入 Z0011 后行 ALND 的数量减少具有统计学意义，这可能导致我们的患者的合并症显著减少。
