S25 Reflecting real-world patients in mesothelioma research: a pre-specified interim report from the pragmatic, prospective, observational ASSESS-meso cohort. (11th November 2022)

• Record Type: Journal Article
• Authors: Smith, N; Conway, R; Cooper, W; Patole, S; Symonds, J; Edey, A; Maskell, NA; Bibby, AC
• Is Part Of: Thorax. Volume 77(2022)Supplement 1
• Page Start: A19
• Page End: A20
• Publication Date: 2022-11-11
• Subjects: Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thorax-2022-BTSabstracts.31
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : Introduction & Objectives: Mesothelioma is a heterogenous disease with variable phenotype and survival. Clinical trials are often affected by selection bias, which can reduce generalisability. ASSESS-meso is a UK, multi-centre, prospective, longitudinal, mesothelioma cohort study (ISRCTN61861764 ). This pre-specified interim analysis, conducted when recruitment reached 25% of target, summarised participant characteristics and evaluated external validity through comparison with real-world and clinical trial cohorts. Methods: The study took place at 14 hospitals across the UK. People with mesothelioma at any anatomical site whose diagnosis had been confirmed at MDT were eligible. Clinical, radiological and biochemical data were collected at enrolment, alongside patient-reported symptom scores. The primary outcome for the overall study is survival. In this interim report, baseline patient, tumour and disease characteristics were described and explored for associations with survival. The external validity of the cohort population was investigated through comparison with data from the 2020 UK National Mesothelioma Audit (real-world cohort), CHECKMATE-743 and MAPS trials (clinical trial cohorts). Results: Between 07/04/2017–01/03/2022, 244 patients enrolled. The cohort was predominantly male (195/244; 80%) with median age of 74. Pleural disease and epithelioid sub-types were most prevalent, consistent with established data. Higher performance status, non-epithelioid histology and neutrophil-lymphocyte ratio were associated with shorter survival in the adjusted analysis. Brims score predicted prognostic group. When compared with other populations, ASSESS-meso participants were closer in similarity to the real-world population with regards age, performance status, disease site and stage than clinical trial population were. ASSESS-meso participants were more likely to be formally staged and less likely to have undifferentiated histology compared with the real-world cohort, which may reflect the high rates of discussion of ASSESS-meso participants at regional mesothelioma MDTs. Conclusion: ASSESS-meso is representative of the UK mesothelioma population. Future outputs from the cohort will help characterise the different mesothelioma phenotypes with high external validity. Stored biological samples provide an opportunity to explore biomarkers of response and progression, and enhance understanding of tumour biology. Please refer to page A208 for declarations of interest related to this abstract.