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. 2021 Oct 29;11(11):2015.
doi: 10.3390/diagnostics11112015.

Pilot Study to Evaluate Serum Soluble Mesothelin-Related Peptide (SMRP) as Marker for Clinical Monitoring of Pleural Mesothelioma (PM): Correlation with Modified RECIST Score

Federica Grosso  1   2 , Matilde Mannucci  3 , Francesca Ugo  4 , Paola Ferro  5 , Maurizio Cassinari  6 , Antonella Vigani  7 , Antonina Maria De Angelis  1 , Sara Delfanti  1 , Michela Lia  1 , Roberto Guaschino  6 , Stefano Barbero  8 , Silvio Roncella  5 , Ugo Giannoni  9 , Marinella Bertolotti  4 , Maria Pia Pistillo  10 , Vincenzo Fontana  3
Affiliations

Pilot Study to Evaluate Serum Soluble Mesothelin-Related Peptide (SMRP) as Marker for Clinical Monitoring of Pleural Mesothelioma (PM): Correlation with Modified RECIST Score

Federica Grosso et al. Diagnostics (Basel). .

Abstract

A soluble mesothelin-related peptide (SMRP) is the only FDA-approved biomarker for diagnosis of pleural mesothelioma (PM) and the most used for monitoring treatment. Radiological assessment of PM, based on modified RECIST (mRECIST) criteria, is challenging. This pilot study was designed to evaluate whether SMRP levels correlated over time with mRECIST score. Serial serum samples from PM patients were collected and SMRP levels were measured and compared with the mRECIST score obtained through centralized CT scans by blinded review. The within-patient SMRP-mRECIST relationship over time was estimated through a normal random-effects regression approach applied to the log-transformed mRECIST score. Overall, 58 PM patients were included (46 males and 12 females) with a median age at diagnosis of 67 years (min-max = 48-79), 44 (76%) with epithelioid and 14 (24%) with non-epithelioid histology. The total number of SMRP measurements and CT scans considered for analysis was 183. There was a statistically significant correlation between SMRP and mRECIST score in the 2 cohorts considered both separately and jointly. These results, although exploratory, suggest that SMRP measurement might be considered as an adjunct to monitor PM patients in order to delay CT scans time interval, thus warranting further investigation.

Keywords: longitudinal study; mesothelin; mesothelioma; modified RECIST; serum biomarkers.

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Conflict of interest statement

F.G. reports, outside the submitted work, personal fees for an advisory role, speaker engagements and travel and accommodation expenses from Merck Sharp and Dohme, Novocure, Bristol Meyer Squibb, Boehringer Ingelheim, Pharmamar, and Novartis. The remaining authors declare no conflict of interest. The funders had no role in the design of the study, in the collection, analyses, or interpretation of data, in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Association between mRECIST score and SMRP levels (double logarithmic scale) estimated through a normal random-effects regression in the AL cohort (A), SP cohort (B) and both cohorts (C). Note: mRECIST: modified RECIST; SMRP: soluble mesothelin-related peptides; log-n: natural logarithm; log-2: base-2 logarithm. Symbols: observed patient-specific levels of log-n-mRECIST score and log-2-SMRP. Thin lines: patient-specific linear relationships between log-n-mRECIST score and log-2-SMRP levels. Thick lines: overall relationship obtained as an average across all patients.
Figure 2
Figure 2
Examples of correlation between mRECIST score and SMRP levels. (A) mRECIST reduction (disease treatment response) correlates with SMRP reduction; (B) mRECIST increase (disease progression) correlates with SMRP increase; mRECIST: modified RECIST; SMRP: soluble mesothelin-related peptides.
See this image and copyright information in PMC

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