Background and objective: cytokeratin-19 fragment (CYFRA21-1) is a soluble protein in serum, and may be a useful circulating tumor marker. The aim of this study is to investigate the diagnostic value of the peripheral blood CYFRA21-1 in non-small cell lung cancer (NSCLC).
Methods: the levels of peripheral blood CYFRA21-1 were detected in 107 patients with NSCLC and 51 patients with benign pulmonary diseases by enzyme linked immunosorbent assay, and ROC curve was used to analyse the results.
Results: singificant difference of peripheral blood CYFRA21-1 levels was detected between the NSCLC group and benign pulmonary disease group (Chi-Square=47.343, P < 0.001). At the threshold of 3.3 ng/mL, sensitivity and specificity of CYFRA21-1 as a serologic marker were 74.77% and 76.47%, respectively for any cancer. ROC curve showed that the under-curve area (AUC) of CYFRA21-1 was 0.813 9. There was no significant difference of CYFRA21-1 between subtypes of NSCLC (Chi-Square=0.450, P=0.799). The peripheral blood CYFRA21-1 level was elevated significantly in the patients with extensive disease (IIIb, IV) compared with patients with limited disase (I, II, IIIb) (Chi-Square=7.057, P=0.008).
Conclusions: as a tumor marker CYFRA21-1 has relative high sensitivity and specificity for the diagnosis of NSCLC. Elevated peripheral blood CYFRA 21-1 levels were usually indicated extensive disease of NSCLC.
背景与目的: 细胞角蛋白19片段（cytokeratin 19 fragment, CYFRA21-1）是血液中的一种可溶性蛋白质，它可能是一种潜在的循环肿瘤标志物。本研究旨在探讨CYFRA21-1在非小细胞肺癌（non-small cell lung cancer, NSCLC）诊断中的应用价值。
方法: 采用酶联免疫吸附法分别检测107例NSCLC患者和51例肺部良性疾病患者外周血中CYFRA21-1含量，应用受试者工作曲线（receiver operaing characteristic curves, ROC）对检测结果进行临床评价。
结果: NSCLC组织与肺良性疾病组外周血CYFRA21-1水平差别有统计学意义（χ2=47.343, P < 0.001）；以3.3 μg/L为诊断临界点，CYFRA21-1诊断NSCLC的敏感性和特异性分别为74.77%和76.47%，ROC曲线下面积为0.813 9；NSCLC各病理类型之间CYFRA21-1水平差别无有统计学意义（χ2=0.450, P=0.799）；外周血CYFRA21-1在广泛期（Ⅲb、Ⅳ）病例中明显高于局限期（Ⅰ、Ⅱ、Ⅲb）病例（χ2=7.057, P=0.008）。
结论: CYFRA21-1作为肺癌肿瘤标志物具有相对较高的敏感性和特异性；血浆中CYFRA21-1水平升高提示肺癌患者可能已经发展为广泛期。