Department of Gynecology and Obstetrics, University of Tübingen, Calwer Strasse 7, 72076, Tübingen, Germany.
Breast Cancer Res Treat. 2010 Nov;124(2):403-12. doi: 10.1007/s10549-010-1163-x. Epub 2010 Sep 22.
There is a growing body of evidence that HER2 status can change during disease recurrence or progression in breast cancer patients. In this context, re-evaluation of HER2 status by assessment of HER2 expression on circulating tumor cells (CTCs) is a strategy with potential clinical application. The aim of this trial was to determine the HER2 status of CTCs in metastatic breast cancer patients comparing two CTC assays. A total of 254 patients with metastatic breast cancer from nine German university breast cancer centers were enrolled in this prospective study. HER2 status of CTCs was assessed using both the FDA-approved CellSearch® assay and AdnaTest BreastCancer™. Using the CellSearch assay, 122 of 245 (50%) patients had ≥5 CTCs, and HER2-positive CTCs were observed in 50 (41%) of these patients. Ninety of 229 (39%) patients were CTC positive using AdnaTest BreastCancer, and HER2 positivity rate was 47% (42 of 90). The rate of breast cancer patients with HER2-negative primary tumors but HER2-positive CTCs was 32% (25 of 78) and 49% (28 of 57) using the CellSearch assay and AdnaTest BreastCancer, respectively. Considering only those patients who had CTCs on both tests (n = 62), concordant results regarding HER2 positivity were obtained in 50% of the patients (31/62) (P = 0.96, κ = -0.006). HER2-positive CTCs can be detected in a relevant number of patients with HER2 negative primary tumors. Therefore, it will be mandatory to correlate the assay-dependent HER2 status of CTCs to the clinical response on HER2-targeted therapies.
越来越多的证据表明，HER2 状态在乳腺癌患者疾病复发或进展过程中可能会发生变化。在这种情况下，通过评估循环肿瘤细胞（CTC）上的 HER2 表达来重新评估 HER2 状态是一种具有潜在临床应用的策略。本试验的目的是通过比较两种 CTC 检测方法，确定转移性乳腺癌患者 CTC 中的 HER2 状态。共有来自德国 9 个大学乳腺癌中心的 254 名转移性乳腺癌患者参与了这项前瞻性研究。使用 FDA 批准的 CellSearch®检测法和 AdnaTest BreastCancer™检测法评估了 CTC 中的 HER2 状态。使用 CellSearch 检测法，245 例患者中有 122 例（50%）患者的 CTC≥5，其中 50 例（41%）患者的 CTC 为阳性。90 例患者使用 AdnaTest BreastCancer 检测为 CTC 阳性，HER2 阳性率为 47%（42/90）。HER2 阴性原发性肿瘤但 CTC 为阳性的乳腺癌患者比例为 32%（25/78）和 49%（28/57），分别使用 CellSearch 检测法和 AdnaTest BreastCancer。仅考虑在两项检测中均有 CTC 的患者（n=62），50%的患者（31/62）的 HER2 阳性结果一致（P=0.96，κ=-0.006）。在 HER2 阴性原发性肿瘤的患者中，能够检测到大量 HER2 阳性 CTC。因此，必须将依赖于检测的 CTC 的 HER2 状态与 HER2 靶向治疗的临床反应相关联。
