Koga H, Eguchi K, Shinkai T, Tamura T, Ohe Y, Oshita F, Saijo N, Kondo H, Oki K, Okura H
Department of Internal Medicine, National Cancer Center Hospital, Tokyo.
Jpn J Clin Oncol. 1994 Oct;24(5):263-8.
Serum samples from 137 lung cancer patients were examined by RIA to evaluate the clinical efficacy of the new tumor marker, CYFRA 21-1, which could identify the soluble fragment of cytokeratin 19. The cut-off value was determined to be 2.2 ng/ml according to the receiver operating characteristic curve. The sensitivity, specificity and accuracy of the RIA for CYFRA 21-1 were 57.7, 91.9 and 64.9%, respectively. The serum concentration of CYFRA 21-1 and the sensitivity of the assay increased as the disease progressed. Histologically, the sensitivity was highest for squamous cell carcinomas (SQ) (76.5%) in comparison with adenocarcinomas (47.8%) and small cell lung cancers (42.1%) (P < 0.01, P < 0.05, respectively). The sensitivities for SQ were 60.0, 83.3, 80.0 and 100% at stages I, II, III and IV, respectively. When compared with CEA (45.3%) and squamous cell carcinoma related antigen (SCC) (22.6%) in all lung carcinomas, CYFRA 21-1 showed the highest sensitivity (57.7%), (P < 0.05, P < 0.01, respectively). In SQ, the sensitivity of the CYFRA 21-1 RIA was significantly higher than that of the assay for SCC (47.1%) (P < 0.05). In patients with adenocarcinomas, the sensitivity of the CYFRA 21-1 assay was almost the same as that for CEA (49.3%). In a combination of CYFRA 21-1 and CEA for non-small cell lung cancers (NSCLC), the sensitivity and accuracy increased to 75.4 and 78.1%, respectively, although the specificity decreased to 86.5%. It is concluded that CYFRA 21-1 could replace SCC, a less satisfactory tumor marker, for SQ of the lung. The potentiality of the combination of CYFRA 21-1 and CEA for NSCLC should be estimated using larger samples in the near future.
采用放射免疫分析法（RIA）检测了137例肺癌患者的血清样本，以评估新型肿瘤标志物CYFRA 21 - 1的临床疗效，该标志物可识别细胞角蛋白19的可溶性片段。根据受试者工作特征曲线，确定临界值为2.2 ng/ml。CYFRA 21 - 1放射免疫分析法的敏感性、特异性和准确性分别为57.7%、91.9%和64.9%。随着疾病进展，CYFRA 21 - 1的血清浓度及检测敏感性均升高。组织学上，与腺癌（47.8%）和小细胞肺癌（42.1%）相比，鳞状细胞癌（SQ）的敏感性最高（76.5%）（P分别<0.01、<0.05）。SQ在Ⅰ、Ⅱ、Ⅲ和Ⅳ期的敏感性分别为60.0%、83.3%、80.0%和100%。在所有肺癌中，与癌胚抗原（CEA）（45.3%）和鳞状细胞癌相关抗原（SCC）（22.6%）相比，CYFRA 21 - 1显示出最高的敏感性（57.7%）（P分别<0.05、<0.01）。在SQ中，CYFRA 21 - 1放射免疫分析法的敏感性显著高于SCC检测法（47.1%）（P<0.05）。在腺癌患者中，CYFRA 21 - 1检测法的敏感性与CEA检测法（49.3%）几乎相同。对于非小细胞肺癌（NSCLC），CYFRA 21 - 1与CEA联合检测时，敏感性和准确性分别提高到75.4%和78.1%，但特异性降至86.5%。结论是，CYFRA 21 - 1可替代SCC（一种不太理想的肿瘤标志物）用于肺癌SQ的检测。近期应用更大样本评估CYFRA 21 - 1与CEA联合检测NSCLC的潜力。
