New Assay System Elecsys Anti-p53 to Detect Serum Anti-p53 Antibodies in Esophageal Cancer Patients and Colorectal Cancer Patients: Multi-institutional Study

Satoshi Yajima, Takashi Suzuki, Yoko Oshima, Fumiaki Shiratori, Kimihiko Funahashi, Shinichi Kawai, Toshihiro Nanki, Sei Muraoka, Yoshihisa Urita, Yoshihisa Saida, Shinichi Okazumi, Yuko Kitagawa, Yuki Hirata, Hirotoshi Hasegawa, Koji Okabayashi, Masahiko Murakami, Takeshi Yamashita, Rei Kato, Hisahiro Matsubara, Kentaro MurakamiYasuaki Nakajima, Hironobu Sugita, Martin Klammer, Hideaki Shimada

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Background: 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). Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)4007-4015
Number of pages9
JournalAnnals of Surgical Oncology
Volume28
Issue number7
DOIs
Publication statusPublished - 2021 Jul

ASJC Scopus subject areas

  • Surgery
  • Oncology

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