新辅助化疗后高选择性 cN1 期乳腺癌患者的靶向腋窝清扫术：一项单中心前瞻性试验。
Targeted axillary dissection after neoadjuvant chemotherapy for highly selective patients with initial cN1 breast cancer: A single-center prospective trial.
机构信息
Department of Breast Disease, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan 450008, China.
出版信息
Chin Med J (Engl). 2024 Jun 20;137(12):1421-1430. doi: 10.1097/CM9.0000000000003007. Epub 2024 Apr 1.
BACKGROUND
Sentinel lymph node (SLN) biopsy is gradually accepted as the standard of care in breast cancer patients with down-staged axillary disease after neoadjuvant chemotherapy (NAC). However, it is still difficult to precisely define pre-NAC clinical node-positive (cN1) and post-NAC clinical node-negative (ycN0). This prospective single-center trial was designed to evaluate the feasibility and accuracy of standard targeted axillary dissection (TAD) after NAC in highly selective pre-NAC cN1 patients (not considering ultrasound-based axillary ycN staging).
METHODS
This prospective trial included patients with initial pre-NAC cT1-3N1M0 invasive breast cancer but with a rigorous definition of cN1 from the Affiliated Cancer Hospital of Zhengzhou University. When NAC was effective (including complete and partial responses) and preoperative axillary palpation was negative, preoperative ultrasound-based axillary staging was not considered, and all patients underwent TAD followed by axillary lymph node (LN) dissection. The detection rate (DR) and false-negative rate (FNR) of TAD were calculated.
RESULTS
A total of 82 patients were included, and 77 of them were eligible for data analysis. The DR for TAD was 94.8% (73/77). There were 26 patients with one abnormal LN at the time of diagnosis based on ultrasound, 45 patients with two, and 2 patients with three. One patient had one TAD LN, four patients had two TAD LNs, and 68 patients had three or more TAD LNs. Preoperative axillary palpation yielded negative results for all 73 patients who successfully underwent TAD. Preoperative ultrasound-based ycN0 and ycN+ conditions were detected for 52 and 21 cases, respectively. The FNR was 7.4% (2/27) for standard TAD (≥3 SLNs), which was lower than that of all successful TAD (≥1 SLN; 10.0%, 3/30).
CONCLUSIONS
In rigorously defined pre-NAC cN1 breast cancer patients, standard TAD is feasible for those with negative axillary palpation after NAC, and FNR is also less than 10%.
REGISTRATION
chictr.org.cn , ChiCTR2100049093.
背景
新辅助化疗（NAC）后降期腋窝疾病的乳腺癌患者逐渐接受前哨淋巴结（SLN）活检作为标准治疗。然而，仍然难以精确定义新辅助化疗前临床淋巴结阳性（cN1）和新辅助化疗后临床淋巴结阴性（ycN0）。本前瞻性单中心试验旨在评估在高度选择性新辅助化疗前 cN1 患者（不考虑基于超声的腋窝 ycN 分期）中，NAC 后标准靶向腋窝清扫术（TAD）的可行性和准确性。
方法
本前瞻性试验纳入了初始新辅助化疗前 cT1-3N1M0 浸润性乳腺癌患者，但来自郑州大学附属肿瘤医院的严格 cN1 定义。当 NAC 有效（包括完全和部分缓解）且术前腋窝触诊阴性时，不考虑术前超声腋窝分期，所有患者均行 TAD 后行腋窝淋巴结（LN）清扫。计算 TAD 的检出率（DR）和假阴性率（FNR）。
结果
共纳入 82 例患者，其中 77 例符合数据分析条件。TAD 的 DR 为 94.8%（73/77）。超声检查时诊断时 26 例患者有 1 个异常 LN，45 例患者有 2 个，2 例患者有 3 个。1 例患者有 1 个 TAD LN，4 例患者有 2 个 TAD LN，68 例患者有 3 个或更多 TAD LN。所有成功行 TAD 的 73 例患者术前腋窝触诊均为阴性。术前超声 ycN0 和 ycN+分别检测到 52 例和 21 例。标准 TAD（≥3 SLN）的 FNR 为 7.4%（2/27），低于所有成功 TAD（≥1 SLN；10.0%，3/30）。
结论
在严格定义的新辅助化疗前 cN1 乳腺癌患者中，对于 NAC 后腋窝触诊阴性的患者，标准 TAD 是可行的，且 FNR 也小于 10%。
注册
chictr.org.cn ， ChiCTR2100049093
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