Unit of Investigative Clinical Oncology (INCO), Institute for Cancer Research and Treatment, Candiolo, Italy.
Ann Surg Oncol. 2012 Nov;19(12):3755-61. doi: 10.1245/s10434-012-2505-1. Epub 2012 Jul 18.
This study was designed to evaluate how the omission of axillary dissection would have altered the indication for adjuvant chemotherapy (ACT) in patients with early breast cancer submitted to conservative surgery with one or two positive sentinel lymph nodes (SLNs).
We identified 321 women in our institutional database who fulfilled the characteristics. All underwent completion axillary lymph node dissection (AD). Each case was blindly reviewed by our breast team in two rounds, and the total number of positive lymph nodes was disclosed only in the second. At each round, the panel chose between: (1) recommend, (2) discuss, (3) do not recommend ACT. Changes between round 1 and 2 were studied by the marginal homogeneity test. Exploratory logistic regression analyses were performed to study predictors of non-SLN involvement and of changes in the indication for ACT.
AD revealed non-SLNs metastases in 96 patients (30 %). Fifty-two patients (16 %) had their initial indication changed at round 2 (p < 0.001). Most of the changes were toward ACT (83 %), and all except two occurred in patients with immunohistochemically defined luminal A and luminal B/HER2-negative tumors. In these two subgroups, a Ki67 above the median value (21 %) was the only independent predictor of no change in the indication to ACT at round 2.
Omission of AD in patients with one or two positive SLNs may change the indication to ACT in a significant proportion of patients with hormone receptor-positive/HER2-negative tumors. All implications should be taken into account before abandoning AD, including a possible biologically tailored surgical approach.
本研究旨在评估在接受保乳手术且有 1 或 2 个阳性前哨淋巴结 (SLN) 的早期乳腺癌患者中,省略腋窝清扫术会如何改变辅助化疗 (ACT) 的适应证。
我们在机构数据库中确定了 321 名符合条件的女性。所有患者均接受了完成的腋窝淋巴结清扫术 (AD)。由我们的乳腺团队进行了两轮盲法审查,仅在第二轮中披露了总阳性淋巴结的数量。在每一轮中,专家组在以下三个选项中进行选择:(1)推荐,(2)讨论,(3)不推荐 ACT。通过边缘同质性检验研究两轮之间的变化。进行探索性逻辑回归分析以研究非 SLN 受累和 ACT 适应证变化的预测因素。
AD 显示 96 例患者(30%)的非 SLN 转移。52 例患者(16%)在第二轮改变了初始适应证(p<0.001)。大多数变化是朝向 ACT(83%),除了两个患者以外,所有变化都发生在免疫组化定义为激素受体阳性/HER2 阴性肿瘤的患者中。在这两个亚组中,Ki67 高于中位数(21%)是第二轮 ACT 适应证不变的唯一独立预测因素。
在 1 或 2 个阳性 SLN 的患者中省略 AD 可能会使相当一部分激素受体阳性/HER2 阴性肿瘤患者的 ACT 适应证发生变化。在放弃 AD 之前,应考虑所有影响因素,包括可能的基于生物学的手术方法。