Assessment of the Cutoff Level of Tumor Markers in Malignant Pleural Effusion

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Abstract Rationale: determining the etiology of exudative pleural effusion solely based on pleural fluid analysis remains a diagnostic dilemma. The limited sensitivity of pleural fluid cytology and the invasiveness of pleural biopsy necessitate alternative diagnostic modalities for differentiation of malignant pleural effusion (MPE) from benign pleural effusion (BPE) in the face of an exudative pleural effusion. In this study, we measured levels of general tumor markers in exudative pleural effusions with the aim to establish cut-off points that correlate with presence of MPE. These cut off points can be used to raise suspicion for MPE and aid with decision weather to perform invasive procedures for instance pleural biopsy or not. Method: In this prospective study, 112 patients with lymphocyte-predominant unilateral exudative pleural effusion were evaluated at Ghaem Hospital, Mashhad, Iran between Jan 2018 to Jan 2020. Pleural biopsy and cytopathological evaluation of pleural fluid performed for all patients.Analysis of tumor markers including carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA125), carbohydrate antigen 19-9 (CA19), and carbohydrate antigen 15-3 (CA15) levels were assessed to establish the best cut-off points for each tumor marker in diagnosing MPE regardless of the type or origin of the malignancy.Analysis of the results stopped due to the pandemic for 2 years but follow-ups continued to carry out by phone.Results: Out of 112 patients 79.5% had BPE, whereas 20.5% were diagnosed with MPE. The derived cut-off points for CEA (>8.50 U/ml), CA15 (>21.50 U/ml), and CA19 (>3.85 U/ml) showed significant correlations with MPE (P-values 0.001, <0.001, and 0.021, respectively), whereas CA125 levels did not demonstrate a statistically significant association. CEA, with a sensitivity of 75.0% and specificity of 82.9%, emerged as a potential biomarker for MPE diagnosis.Conclusions: This study contributes to the body of evidence supporting the role of specific tumor markers in pleural fluid to aid diagnosis of MPE, with CEA featuring prominently as a reliable biomarker. The diagnosis of MPE can be substantially improved using of these tumor markers, and may facilitate early and non-invasive detection of BPE that may reduce the need for invasive procedures.

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