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

  • Translational Research
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Annals of Surgical Oncology Aims and scope Submit manuscript

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

  1. 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.

Author information

Authors and Affiliations

  1. Department of Surgery, School of Medicine, Toho University, Tokyo, Japan

    Satoshi Yajima MD, Takashi Suzuki MD, Yoko Oshima MD, Fumiaki Shiratori MD, Kimihiko Funahashi MD & Hideaki Shimada MD

  2. Department of Inflammation and Pain Control Research, School of Medicine, Toho University, Tokyo, Japan

    Shinichi Kawai MD

  3. Division of Rheumatology, Department of Internal Medicine, School of Medicine, Toho University, Tokyo, Japan

    Toshihiro Nanki MD & Sei Muraoka MD

  4. General Medicine and Emergency Center, School of Medicine, Toho University, Tokyo, Japan

    Yoshihisa Urita MD

  5. Department of Surgery, Ohashi Medical Center, Toho University, Tokyo, Japan

    Yoshihisa Saida MD

  6. Department of Surgery, Sakura Medical Center, Toho University, Tokyo, Japan

    Shinichi Okazumi MD

  7. Department of General and Gastroenterological Surgery, Keio University Hospital, Tokyo, Japan

    Yuko Kitagawa MD, Yuki Hirata MD, Hirotoshi Hasegawa MD & Koji Okabayashi MD

  8. Department of Surgery, Showa University Hospital, Tokyo, Japan

    Masahiko Murakami MD, Takeshi Yamashita MD & Rei Kato MD

  9. Department of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan

    Hisahiro Matsubara MD & Kentaro Murakami MD

  10. Esophageal Surgery, Medical Hospital, Tokyo Medical and Dental University, Tokyo, Japan

    Yasuaki Nakajima MD

  11. Roche Diagnostics K.K, Tokyo, Japan

    Hironobu Sugita MSc

  12. Department of Biostatistics and Advanced Data Analytics, Roche Diagnostics GmbH, Penzberg, Germany

    Martin Klammer PhD

  13. Department of Gastroenterological Surgery and Clinical Oncology, Graduate School of Medicine, Toho University, Tokyo, Japan

    Hideaki Shimada MD

Authors
  1. Satoshi Yajima MD
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  2. Takashi Suzuki MD
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  3. Yoko Oshima MD
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  4. Fumiaki Shiratori MD
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  5. Kimihiko Funahashi MD
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  6. Shinichi Kawai MD
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  7. Toshihiro Nanki MD
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  8. Sei Muraoka MD
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  9. Yoshihisa Urita MD
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  10. Yoshihisa Saida MD
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  11. Shinichi Okazumi MD
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  12. Yuko Kitagawa MD
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  13. Yuki Hirata MD
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  14. Hirotoshi Hasegawa MD
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  15. Koji Okabayashi MD
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  16. Masahiko Murakami MD
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  17. Takeshi Yamashita MD
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  18. Rei Kato MD
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  19. Hisahiro Matsubara MD
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  20. Kentaro Murakami MD
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  21. Yasuaki Nakajima MD
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  22. Hironobu Sugita MSc
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  23. Martin Klammer PhD
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  24. Hideaki Shimada MD
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Contributions

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.

Corresponding author

Correspondence to Hideaki Shimada MD.

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Disclosure

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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