Department of Surgery, School of Medicine, Toho University, Tokyo, Japan.
Department of Inflammation and Pain Control Research, School of Medicine, Toho University, Tokyo, Japan.
Ann Surg Oncol. 2021 Jul;28(7):4007-4015. doi: 10.1245/s10434-020-09342-4. Epub 2020 Nov 18.
Several recent studies suggest that serum anti-p53 antibodies (s-p53-Abs) may be combined with other markers to detect esophageal and colorectal cancer. In this study, we assessed the sensitivity and specificity of s-p53-Abs detection of a new electrochemiluminescence immunoassay (ECLIA; Elecsys anti-p53).
Elecsys anti-p53 assay was used to analyze the level of s-p53-Abs in blood sera from patients with esophageal or colorectal cancer taken before treatment. Control blood sera from healthy volunteers, patients with benign diseases, and patients with autoimmune diseases served as a reference. In addition, squamous cell carcinoma antigen (SCC-Ag) and cytokeratin 19 fragments (CYFRA21-1) were assessed in patients with esophageal cancer, and carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 19-9 were assessed in patients with colorectal cancer.
Samples from 281 patients with esophageal cancer, 232 patients with colorectal cancer, and 532 controls were included in the study. The median value of s-p53-Abs in control samples was < 0.02 μg/mL (range < 0.02-29.2 μg/mL). Assuming 98% specificity, the cut-off value was determined as 0.05 μg/mL. s-p53-Abs were detected in 20% (57/281) of patients with esophageal cancer and 18% (42/232) of patients with colorectal cancer. In combination with SCC-Ag and CEA, respectively, s-p53-Abs detected 51% (144/281) of patients with esophageal and 53% (124/232) of patients with colorectal cancer.
The new s-p53-Abs assay Elecsys anti-p53 was useful in detecting esophageal and colorectal cancers with high specificity. Adding s-p53-Abs to conventional markers significantly improved the overall detection rates.
最近的几项研究表明，血清抗 p53 抗体（s-p53-Abs）可能与其他标志物结合，用于检测食管癌和结直肠癌。在这项研究中，我们评估了新电化学发光免疫分析（ECLIA；Elecsys anti-p53）检测 s-p53-Abs 的敏感性和特异性。
使用 Elecsys anti-p53 分析试剂盒检测治疗前食管癌或结直肠癌患者的血清 s-p53-Abs 水平。健康志愿者、良性疾病患者和自身免疫性疾病患者的血清作为对照。此外，还评估了食管癌患者的鳞状细胞癌抗原（SCC-Ag）和细胞角蛋白 19 片段（CYFRA21-1），以及结直肠癌患者的癌胚抗原（CEA）和糖链抗原（CA）19-9。
本研究纳入了 281 例食管癌患者、232 例结直肠癌患者和 532 例对照的样本。对照组样本中 s-p53-Abs 的中位数值<0.02μg/mL（范围<0.02-29.2μg/mL）。假设特异性为 98%，确定截断值为 0.05μg/mL。在 281 例食管癌患者中，有 20%（57/281）检测到 s-p53-Abs，在 232 例结直肠癌患者中，有 18%（42/232）检测到 s-p53-Abs。分别与 SCC-Ag 和 CEA 联合检测时，s-p53-Abs 检测到 281 例食管癌患者中的 51%（144/281）和 232 例结直肠癌患者中的 53%（124/232）。
新型 s-p53-Abs 检测试剂盒 Elecsys anti-p53 对食管癌和结直肠癌具有高特异性，与常规标志物联合应用可显著提高总体检出率。
