Surgical Breast Oncology, Mercy Health, Fairfield Hospital, Fairfield, OH.
Division of Surgical Oncology, Levine Cancer Institute, Charlotte, NC.
Clin Breast Cancer. 2018 Aug;18(4):270-275. doi: 10.1016/j.clbc.2017.10.006. Epub 2017 Oct 12.
The ACOSOG (American College of Surgeons Oncology Group) Z1071 assessed the feasibility of performing sentinel lymph node biopsy (SLNB) in node-positive patients who completed neoadjuvant chemotherapy (NACT). Historically, adoption of clinical research into practice takes years. The goal of this study was to determine the effect of Z1071 on our practice.
This is a retrospective review of Z1071's influence on a single institution's practice. Patients with biopsy-proven positive axillary lymph nodes before NACT were eligible for the study. After NACT, patients with nodal response according to imaging and exam were candidates for SLNB. Two cohorts were stratified according to diagnosis date before and after Z1071 results were presented on December 5, 2012 at the San Antonio Breast Cancer Symposium. Fisher exact tests and nonparametric rank tests were used to compare cohorts.
The pre-Z1071 cohort included 74 patients and the post-Z1071 cohort 56 for a total of 130 patients. Post-Z1071, 73% (41/56) underwent a SLNB with an average of 4 nodes removed. Moreover, 27% (15/56) of patients had an axillary lymph node dissection as first intervention post-Z1071, compared with 99% (73/74) pre-Z1071. Axillary pathologic complete response pre-Z1071 was 35% (26/74) and post-Z1071 was 27% (15/56) (P = .35).
This report shows that meaningful practice changes can be implemented rapidly. Changes in practice generated by clinical trial results should be monitored and outcomes followed.
ACOSOG（美国外科医师学院肿瘤学组）Z1071 评估了在完成新辅助化疗（NACT）的淋巴结阳性患者中进行前哨淋巴结活检（SLNB）的可行性。从历史上看，将临床研究成果应用于实践需要数年时间。本研究的目的是确定 Z1071 对我们实践的影响。
这是对单一机构实践中 Z1071 影响的回顾性研究。在 NACT 前经活检证实有阳性腋窝淋巴结的患者有资格参加研究。在 NACT 后，根据影像学和检查结果有淋巴结反应的患者有资格进行 SLNB。根据 Z1071 结果于 2012 年 12 月 5 日在圣安东尼奥乳腺癌研讨会上公布前后的诊断日期，将患者分为两个队列。使用 Fisher 确切检验和非参数秩检验比较队列。
Z1071 前队列包括 74 例患者，Z1071 后队列包括 56 例患者，共 130 例患者。Z1071 后，73%（41/56）进行了 SLNB，平均切除 4 个淋巴结。此外，27%（15/56）的患者在 Z1071 后首先进行腋窝淋巴结清扫术，而 Z1071 前为 99%（73/74）。Z1071 前腋窝病理完全缓解率为 35%（26/74），Z1071 后为 27%（15/56）（P=0.35）。
本报告表明，可以迅速实施有意义的实践改变。应监测并跟踪临床试验结果引起的实践变化及其结果。
