Mesothelin is currently considered the best available serum biomarker for malignant pleural mesothelioma. To examine the reported diagnostic accuracy of mesothelin and evaluate its value for early diagnosis, the authors performed a meta-analysis on the individual patient data (IPD) of 16 diagnostic studies, representing a total of 4,491 individuals, including 1,026 patients with malignant pleural mesothelioma.
They found a significant heterogeneity in reported diagnostic accuracies of mesothelin (see Figure for sensitivity of mesothelin in different studies). Differences in study population can explain this heterogeneity, since the type of control group, mesothelioma stage, and histological subtype were found to affect the diagnostic accuracy.
Moreover, they examined mesothelin in two clinically relevant settings: as an adjunct to rule in or to rule out early-stage mesothelioma. Results indicated that it would not be advisable to use a negative mesothelin test to exclude mesothelioma, even at a high-sensitivity threshold. Conversely, a positive mesothelin test at a high-specificity threshold would provide a strong incentive to urge ensuing diagnostic steps, but the associated poor sensitivity (about 30%) at that level clearly limits the added value to early diagnosis.
Several approaches to anticipate the limited accuracy of serum mesothelin are discussed in this manuscript, together with other directions for further biomarker research. For any novel candidate biomarker of mesothelioma, it will be essential to evaluate its accuracy in direct comparison with mesothelin in a sufficiently large study population, including relevant controls, such as healthy asbestos-exposed individuals and patients with lung cancer, and patients with early stage mesothelioma.
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