Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Viale Morgagni, 85 - 50134, Firenze, Italy.
Gynecol Oncol. 2010 Feb;116(2):234-9. doi: 10.1016/j.ygyno.2009.10.067. Epub 2009 Nov 17.
Knowledge of HER-2/neu status is mandatory to identify breast cancer patients amenable to trastuzumab treatment. We evaluated the diagnostic performance of quantitative real-time polymerase chain reaction (qRT-PCR) in the preoperative determination of HER-2/neu status in breast cancer, using core biopsy material.
In a prospective series, qRT-PCR was performed on fresh core biopsy specimens taken preoperatively in 87 patients with breast carcinoma. Cases with qRT-PCR ratio > or = 2.0 were considered to have HER-2/neu amplification. The results of RT-PCR analysis were compared with those of the standard immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH) methods. Cases with IHC 3+ or with IHC 2+ and FISH showing amplification were considered HER-2/neu positive. All other cases were considered HER-2/neu negative.
qRT-PCR showed HER-2/neu amplification in 13 cases (14.9%), while the standard IHC-FISH combined approach identified 17 HER-2/neu-positive cases (19.5%). Overall, there was concordance between methods in 83 of 87 patients (95.4%). The Spearman's rho correlation coefficient was 0.851; p<0.001. The diagnostic performance for preoperative diagnosis of HER-2/neu status using RT-PCR on core biopsy specimens as compared to standard approach was as follows: sensitivity 76.5%; specificity 100%; positive predictive value 100%; negative predictive value 94.6%.
Quantitative RT-PCR determination of HER-2/neu status from core biopsy specimens provided results comparable to those given by the standard IHC and FISH methods. The use of qRT-PCR on core biopsy material may represent a very useful and easy tool to enhance early identification of HER-2/neu-positive breast cancer patients who, possibly can benefit from trastuzumab treatment.
为了识别适合曲妥珠单抗治疗的乳腺癌患者，HER-2/neu 状态的知识是必要的。我们评估了定量实时聚合酶链反应（qRT-PCR）在乳腺癌术前确定 HER-2/neu 状态的诊断性能，使用核心活检材料。
在一项前瞻性系列研究中，对 87 例乳腺癌患者术前采集的新鲜核心活检标本进行 qRT-PCR。qRT-PCR 比值≥2.0 的病例被认为存在 HER-2/neu 扩增。将 RT-PCR 分析结果与标准免疫组织化学（IHC）和荧光原位杂交（FISH）方法的结果进行比较。IHC 3+或 IHC 2+且 FISH 显示扩增的病例被认为是 HER-2/neu 阳性。所有其他病例均被认为是 HER-2/neu 阴性。
qRT-PCR 显示 13 例（14.9%）存在 HER-2/neu 扩增，而标准 IHC-FISH 联合方法则确定了 17 例 HER-2/neu 阳性病例（19.5%）。总体而言，87 例患者中有 83 例（95.4%）方法一致。Spearman's rho 相关系数为 0.851；p<0.001。与标准方法相比，核心活检标本上的 RT-PCR 用于术前 HER-2/neu 状态诊断的诊断性能如下：敏感性 76.5%；特异性 100%；阳性预测值 100%；阴性预测值 94.6%。
从核心活检标本中定量 RT-PCR 确定 HER-2/neu 状态的结果与标准 IHC 和 FISH 方法相当。核心活检材料上 qRT-PCR 的使用可能是一种非常有用且简便的工具，可增强对曲妥珠单抗治疗可能受益的 HER-2/neu 阳性乳腺癌患者的早期识别。
