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Background:   Malignant pleural mesothelioma (MPM) is a rapidly fatal tumor of increasing worldwide incidence. Diagnosis of MPM may be difficult and is an area of academic and clinical interest. Diagnosis by effusion cytology is controversial, and the clinical utility of soluble biomarkers, particularly mesothelin, remains unexplored in the difficult to diagnose patient.Objectives:   We studied the diagnostic value of measuring mesothelin in patients with cytology-negative pleural effusion undergoing medical thoracoscopy.Methods:   Patients were enrolled prospectively and underwent medical thoracoscopy. Biopsy samples were reviewed following standard care guidelines. Soluble mesothelin was quantitated by commercial enzyme-linked immunosorbent assay in effusion and serum samples collected at the time of thoracoscopy. Patients were followed up until death or for a median of 28 (interquartile range 18-43) months.Results:   Biopsy for thoracoscopy was definitive for malignancy in 17 of the 36 cases (16 MPM and 1 lung adenocarcinoma) and suspicious of malignancy in 6 cases. A final diagnosis of malignancy was made for 27 cases (24 MPM, 2 lung adenocarcinoma, and 1 primary pleural T-cell lymphoma). At thoracoscopy, soluble mesothelin was elevated in the effusion of 13 cases all of which were MPM. Serum mesothelin was elevated in 6 cases with MPM. One case with elevated mesothelin on whom thoracoscopic biopsy demonstrated a pleural plaque was diagnosed with metastatic MPM 9 months later.Conclusion:   Elevated effusion mesothelin had a positive predictive value of 100% for a final diagnosis of MPM. Elevated mesothelin, in effusion or serum, should raise the index of suspicion of malignancy and warrants continued clinical follow-up.

Role of Mesothelin Measurement in Patients With Cytology-Negative Pleural Effusion Undergoing Medical Thoracoscopy