Zhang Xia, Zhou Jian-Guo, Wu Hua-Lian, Ma Hu, Jiang Zhi-Xia
Department of Nursing, Affiliated Hospital of Zunyi Medical College, Zunyi 563000, China.
Department of Oncology, Affiliated Hospital of Zunyi Medical College, Zunyi 563000, China.
Oncotarget. 2017 May 17;8(43):75400-75410. doi: 10.18632/oncotarget.17914. eCollection 2017 Sep 26.
Anaplastic lymphoma kinase (ALK) gene fusion has been reported in 3∼5% non-small cell lung carcinoma (NSCLC) patients, and polymerase chain reaction (PCR) is commonly used to detecting the gene status, but the diagnostic capacity of it is still controversial. A systematic review and meta-analysis was conducted to clarify the diagnostic accuracy of PCR for detecting ALK gene rearrangement in NSCLC patients.
18 articles were enrolled, which included 21 studies, involving 2800 samples from NSCLC patients. The overall pooled parameters were calculated: sensitivity was 92.4% [95% confidence interval (CI): 82.2%-97.0%], specificity was 97.8% [95% CI: 95.1%-99.0%], PLR was 41.51 [95% CI: 18.10-95.22], NLR was 0.08 [95% CI: 0.03-0.19], DOR was 535.72 [95% CI: 128.48-2233.79], AUROC was 0.99 [95% CI: 0.98-1.00].
Relevant articles were searched from PubMed, EMBASE, Web of Science, Cochrane library, American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), China National Knowledge Infrastructure (CNKI), China Wan Fang databases and Chinese biomedical literature database (CBM). Diagnostic capacity of PCR test was assessed by the pooled sensitivity and specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), area under the summary receiver operating characteristic (AUROC).
Based on the results from this review, PCR has good diagnostic performance for detecting the ALK gene fusion in NSCLC patients. Moreover, due to the poor methodology quality of the enrolled trials, more well-designed multi-center trials should be performed.
间变性淋巴瘤激酶（ALK）基因融合在3%至5%的非小细胞肺癌（NSCLC）患者中已有报道，聚合酶链反应（PCR）常用于检测该基因状态，但其诊断能力仍存在争议。进行了一项系统评价和荟萃分析，以阐明PCR检测NSCLC患者ALK基因重排的诊断准确性。
纳入18篇文章，其中包括21项研究，涉及来自NSCLC患者的2800份样本。计算了总体合并参数：敏感性为92.4%[95%置信区间（CI）：82.2%-97.0%]，特异性为97.8%[95%CI：95.1%-99.0%]，阳性似然比（PLR）为41.51[95%CI：18.10-95.22]，阴性似然比（NLR）为0.08[95%CI：0.03-0.19]，诊断比值比（DOR）为535.72[95%CI：128.48-2233.79]，曲线下面积（AUROC）为0.99[95%CI：0.98-1.00]。
从PubMed、EMBASE、科学网、Cochrane图书馆、美国临床肿瘤学会（ASCO）、欧洲医学肿瘤学会（ESMO）、中国知网、中国万方数据库和中国生物医学文献数据库（CBM）中检索相关文章。通过合并敏感性和特异性、阳性似然比（PLR）、阴性似然比（NLR）、诊断比值比（DOR）、汇总受试者工作特征曲线下面积（AUROC）来评估PCR检测的诊断能力。
基于本综述的结果，PCR在检测NSCLC患者ALK基因融合方面具有良好的诊断性能。此外，由于纳入试验的方法学质量较差，应开展更多设计良好的多中心试验。
