Werner Dominique, Battmann Achim, Steinmetz Kristina, Jones Tobin, Lamb Tiffany, Martinez Michele, Altmannsberger Hans-Michael, Al-Batran Salah-Eddin
Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center Frankfurt, Steinbacher Hohl 2-26, 60488, Frankfurt/Main, Germany.
J Transl Med. 2014 Jun 6;12:160. doi: 10.1186/1479-5876-12-160.
HER2 status assessment is a prerequisite for the establishment of an appropriate treatment strategy in gastric cancer. Gastric cancers are very heterogeneous and separate evaluations of gene amplification and protein expression lead to uncertainties in localizing distinct clones and are time consuming. This study evaluates the equivalence of the novel method combining both gene and protein platforms on one slide.
Immunohistochemistry (IHC) and HER2 dual-colour silver in situ hybridization (SISH) as single methods (IHC/SISH) and gene-protein platform combining both methods on one slide (gene/protein) were performed in randomly collected 100 cases of gastric adenocarcinoma. Results of IHC/SISH were compared with gene/protein staining.
96 of 100 samples were assessable. In the gene/protein staining, pathologists were able to assess gene amplification and consequent protein expression at the single cell level. In comparison trials, gene amplification was observed in 14.6% by both, conventional SISH and gene/protein platform (agreement 100%; Kappa-coefficient κ = 1.0). Protein expression scores by IHC were 70.8% (0), 10.4% (1+), 9.4% (2+), and 9.4% (3+). Protein expression by gene/protein method were: 70.8% (0), 11.5% (1+), 7.3% (2+) and 10.4% (3+) of patients. There were complete concordances in IHC assessment of cases with score 0 (100.0%; κ = 1). High concordances are shown in score 1+ (98.96%; κ = 0.947) and 3+ (96.88%; κ = 0.825) cases and good concordances in 2+ cases (95.83%; κ = 0.728).
This novel combined platform has the advantage of being able to evaluate both gene and the protein status in the same cancer cell and may be of particular interest for research and patient's care.
Disease Biomarker.
人表皮生长因子受体2（HER2）状态评估是制定合适的胃癌治疗策略的前提条件。胃癌具有高度异质性，对基因扩增和蛋白表达进行单独评估会导致在定位不同克隆时存在不确定性，且耗时较长。本研究评估了在一张载玻片上结合基因和蛋白平台的新方法的等效性。
对随机收集的100例胃腺癌病例进行免疫组织化学（IHC）和HER2双色银原位杂交（SISH），分别作为单一方法（IHC/SISH）以及在一张载玻片上结合这两种方法的基因-蛋白平台（基因/蛋白）检测。将IHC/SISH的结果与基因/蛋白染色结果进行比较。
100个样本中有96个可评估。在基因/蛋白染色中，病理学家能够在单细胞水平评估基因扩增及相应的蛋白表达。在对比试验中，传统SISH和基因/蛋白平台检测到基因扩增的比例均为14.6%（一致性100%；卡帕系数κ = 1.0）。IHC检测的蛋白表达评分分别为：70.8%（0）、10.4%（1+）、9.4%（2+）和9.4%（3+）。基因/蛋白方法检测的患者蛋白表达情况为：70.8%（0）、11.5%（1+）、7.3%（2+）和10.4%（3+）。IHC对评分为0的病例评估完全一致（100.0%；κ = 1）。评分为1+（98.96%；κ = 0.947）和3+（96.88%；κ = 0.825）的病例一致性高，评分为2+的病例一致性良好（95.83%；κ = 0.728）。
这种新型联合平台具有能够在同一癌细胞中评估基因和蛋白状态的优势，可能对研究和患者护理具有特殊意义。
疾病生物标志物
