Jain D, Jangra K, Malik P S, Arulselvi S, Madan K, Mathur S, Sharma M C
Department of Pathology, All India Institute of Medical Sciences, New Delhi, India.
Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.
Indian J Cancer. 2017 Jan-Mar;54(1):209-213. doi: 10.4103/0019-509X.219588.
Immunohistochemistry (IHC) with anaplastic lymphoma kinase (ALK) antibodies is considered as an economical screening method in lung adenocarcinomas. Automated Ventana D5F3-IHC is approved by US Food and Drug Administration for targeted therapy; however, the automated IHC apparatus are not widely used in most laboratories. We evaluated the performance of ALK IHC using the manual semiquantitative method to assess the concordance with Ventana ALK IHC assay.
We tested 156 cases of primary lung adenocarcinomas for ALK protein expression by D5F3-IHC. The intensity of cytoplasmic staining was classified as 0 or 1+/2+/3+ (weak/medium/strong). Binary score of positive and negative was used for Ventana assay. A comparison analysis and clinicopathological features were recorded.
ALK IHC was positive in 25 (16.02%) cases, of which 18 were men and mostly nonsmokers. The mean age for all patients was 55 years, and for ALK IHC-positive cases was 48 years. Nine of 25 (36%) ALK IHC-positive cases showed signet ring cell and mucinous morphology. On comparison, all, but one, cases positive by manual method showed positive results by automated assay. IHC negative cases by manual method were negative by Ventana assay.
Manual IHC is equally effective in the detection of ALK-rearranged cases as automated methods. It can be easily integrated as a screening method into routine practice thus reducing the cost of automated systems. However, equivocal cases should be tested by approved methods.
使用间变性淋巴瘤激酶（ALK）抗体进行免疫组织化学（IHC）检测被认为是肺腺癌一种经济的筛查方法。自动Ventana D5F3-IHC检测已获美国食品药品监督管理局批准用于靶向治疗；然而，自动免疫组化仪器在大多数实验室并未广泛使用。我们使用手动半定量方法评估ALK免疫组化的性能，以评估其与Ventana ALK免疫组化检测结果的一致性。
我们通过D5F3-IHC检测了156例原发性肺腺癌中ALK蛋白的表达。细胞质染色强度分为0或1+/2+/3+（弱/中/强）。Ventana检测采用阳性和阴性的二元评分。记录比较分析结果及临床病理特征。
ALK免疫组化检测中25例（16.02%）呈阳性，其中18例为男性，且大多为非吸烟者。所有患者的平均年龄为55岁，ALK免疫组化阳性病例的平均年龄为48岁。25例ALK免疫组化阳性病例中有9例（36%）表现为印戒细胞和黏液样形态。相比之下，手动方法检测为阳性的病例中，除1例以外，其余所有病例经自动检测均呈阳性。手动方法检测为免疫组化阴性的病例，Ventana检测也为阴性。
手动免疫组化在检测ALK重排病例方面与自动方法同样有效。它可轻松作为一种筛查方法纳入常规实践，从而降低自动检测系统的成本。然而，难以判断的病例应采用经批准的方法进行检测。
