中文摘要：

目的：研究非小细胞肺癌患者的间变性淋巴瘤激酶（anaplastic lymphoma kinase,ALK）融合基因的表达情况和临床病理特点.方法：从北京大学第三医院随机选择了有随访资料的95例非小细胞肺癌患者,采用ALK＋插入式抗体强化免疫组织化学法（intercalated antibody-enhanced polymer,iAEP）和荧光原位杂交技术（fluorescence in situ hybridization,FISH）检测患者ALK融合基因的表达情况,并分析ALK融合基因阳性患者的临床病理特点、生存期和EGFR/KRAS基因突变情况.结果：采用ALK＋ iAEP法共筛选出8例AL阳性病例,其中4例经FISH法证实存在ALK融合基因,检出率为4.2％ （4/95）,其中2例女性肺癌患者的组织学类型是实体性肺腺癌伴印戒细胞形态,另2例男性肺癌患者是腺鳞癌.4例肺癌患者中3例为非吸烟者,均无EGFR/KRAS基因突变,且均存活,其中有2例患者已存活超过5年.结论：ALK＋ iAEP法较常规ALK免疫组织化学法能明显提高肺癌患者ALK的检出率,可以作为初筛ALK阳性病例的方法,且阳性细胞的比例较阳性强度更重要.ALK融合基因在非小细胞肺癌患者中的检出率较低（＜5％）,同时可能提示预后较好.

英文摘要：

Objective ： To examine the prevalence of anaplastic lymphoma kinase （ALK） fusion gene in Chinese patients with non-small cell lung cancer （NSCLC）. Methods： In this study, 95 patients with NSCLC and corresponding clinical information and formalin-fixed paraffin-embedded （FFPE） tissue blocks were included. Hematoxylin ＆ eosin （HE） staining, conventional ALK immunochemistry （IHC） staining and intercalated antibody-enhanced polymer （iAEP） IHC staining, and dual-color split fluores- cence in situ hybridization （FISH） for ALK fusion gene were performed. Results： Eight ALK-positive ca- ses were detected using anti-ALK immunohistochemistry with the iAEP method, and FISH analyses re- vealed 4 patients of them who harbored the ALK fusion gene （4.2% , 4/95 ） , including 2 cases of female patients with solid signet-ring cell adenocarcinoma and 2 cases of male patients with adenosquamous car- cinoma. The positive cases were all non-smokers without EGFR/KRAS mutations. Furthermore, the posi- tive cases all survived, and the overall postsurgery survival time of 2 eases was more than 5 years. Con- clusion： ALK IHC with the iAEP method is better than conventional ALK IHC, and the percentage of the positive cells is more important than that of the intensity. ALK translocations were infrequent in the entire NSCLC oatient oooulation （ 〈 5% ） with better orognosis.