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Sensitive and Specific New Enzyme-Linked Immunosorbent Assay for N-ERC/Mesothelin Increases its Potential as a Useful Serum Tumor Marker for Mesothelioma

Authors' Affiliations: ¹ Department of General Thoracic Surgery, Respiratory Medicine, Human Pathology and ² Department of Pathology and Oncology, Juntendo University, School of Medicine; ³ Department of Respiratory Diseases, National Organization Tokyo Hospital; ⁴ Department of Respiratory Medicine, Fukujuji Hospital, Japan Antituberculosis Association; ⁵ Hirano Kameido Himawari Clinic, Tokyo, Japan; ⁶ Immuno-Biological Laboratories Co., Ltd., Gunma, Japan; ⁷ Department of Respiratory Medicine, Hyogo Prefectural Tsukaguchi Hospital, Hyogo, Japan; ⁸ Division of General Thoracic Surgery, Yokosuka Kyosai Hospital; ⁹ Division of Respiratory and Infectious Diseases, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan; and ¹⁰ Respiratory Medicine and Translational Research Clinic, Tohoku University Hospital, Miyagi, Japan

Requests for reprints: Okio Hino, Department of Pathology and Oncology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan. E-mail: ohino{at}med.juntendo.ac.jp.

Background: Because mesothelioma initially progresses on the surface of the pleura and peritoneum without forming masses, it has been difficult to diagnose at an early stage. It would be very useful to identify a tumor marker that could be used for screening to enable more diagnoses to be made at an early, treatable stage.

Materials and Methods: We had previously identified N-ERC/mesothelin as a potential biomarker for mesothelioma. In the current work, we used a newly developed ELISA system to gain data on N-ERC/mesothelin levels in various clinical settings. A total of 102 healthy volunteers were recruited. In addition, 39 patients were diagnosed with mesothelioma, 53 patients were diagnosed with diseases that should be distinguished from mesothelioma, and 201 subjects were diagnosed with asbestos-related nonmalignant diseases (including simple exposure to asbestosis) who were treated at any of the cooperating hospitals were enrolled.

Results: Serum N-ERC/mesothelin levels measured by a new ELISA system showed that the median values from patients with mesothelioma were extremely high compared with levels obtained from other patients. Analysis in terms of histologic type showed that serum levels of N-ERC/mesothelin were elevated in epithelioid type mesothelioma, especially. In four important models of clinical settings, the sensitivity and specificity of N-ERC/mesothelin were about 71% to 90% and 88% to 93%, respectively.

Conclusion: N-ERC/mesothelin is a very promising tumor marker for mesothelioma, especially epithelioid mesothelioma.