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.
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Notes
ELECSYS is a trademark of Roche.
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Acknowledgments
The authors thank Seiko Otsuka for providing technical assistance. Editorial support was provided by Olga Ucar and Clair Clowes of inScience Communications, Springer Healthcare (Chester, UK) and was funded by Roche Diagnostics.
Funding
This work was supported by JSPS KAKENHI (Grant No. JP16K10520) and a research grant from Roche Diagnostics.
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Hideaki Shimada and Roche Diagnostics K.K. were responsible for the study design. 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 Murakami, Yasuaki Nakajima, and Hideaki Shimada were responsible for sample and data collection. Martin Klammer performed the statistical data analysis. Hideaki Shimada and Hironobu Sugita drafted the initial version of the manuscript. All authors critically reviewed the manuscript and approved the final version for submission.
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All sites received research funding from Roche Diagnostics K.K. Hironobu Sugita is an employee of Roche Diagnostics K.K., and Martin Klammer is an employee of Roche Diagnostics GmbH. Sei Muraoka has received consultant fees from Asahikasei Pharma Corporation, and speakers bureau fees from Ono Pharmaceutical Co., Ltd, Eisai Co., Ltd, Asahikasei Pharma Corporation, and Astellas Pharma Inc. Yuko Kitagawa has relevant financial activities outside the submitted work: Taiho Pharmaceutical Co., Ltd; Chugai Pharmaceutical Co., Ltd; Yakult Honsha Co., Ltd; Daiichi Sankyo Company, Ltd; Merck Serono Co., Ltd; Asahikasei Co., Ltd; EA Pharma Co., Ltd; Otsuka Pharmaceutical Co., Ltd; Takeda Pharmaceutical Co., Ltd; Otsuka Pharmaceutical Factory Inc.; Shionogi & Co., Ltd; Kaken Pharmaceutical Co., Ltd; Kowa Pharmaceutical Co., Ltd; Astellas Pharma Inc.; Medicon Inc.; Dainippon Sumitomo Pharma Co., Ltd; Taisho Toyama Pharmaceutical Co., Ltd; Kyouwa Hakkou Kirin Co., Ltd; Pfizer Japan Inc.; Ono Pharmaceutical Co., Ltd; Nihon Pharmaceutical Co., Ltd; Japan Blood Products Organization; Medtronic Japan Co., Ltd; and Sanofi K.K. Yuko Kitagawa has also received grants from Eisai Co., Ltd; Tsumura & Co.; KCI Licensing, Inc.; Abbott Japan Co., Ltd; Fujifilm Toyama Chemical Co., Ltd; and Medicon Inc. Hideaki Shimada has received lecture fees from Ono Pharmaceuticals Ltd and Taiho Pharmaceuticals Ltd. Satoshi Yajima, Takashi Suzuki, Yoko Oshima, Fumiaki Shiratori, Kimihiko Funahashi, Shinichi Kawai, Toshihiro Nanki, Yoshihisa Urita, Yoshihisa Saida, Shinichi Okazumi, Yuki Hirata, Hirotoshi Hasegawa, Koji Okabayashi, Masahiko Murakami, Takeshi Yamashita, Rei Kato, Hisahiro Matsubara, Kentaro Murakami, and Yasuaki Nakajima have no conflicts of interest to declare.
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Yajima, S., Suzuki, T., Oshima, Y. et al. New Assay System Elecsys Anti-p53 to Detect Serum Anti-p53 Antibodies in Esophageal Cancer Patients and Colorectal Cancer Patients: Multi-institutional Study. Ann Surg Oncol 28, 4007–4015 (2021). https://doi.org/10.1245/s10434-020-09342-4
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DOI: https://doi.org/10.1245/s10434-020-09342-4