Prognostic factors for progression of MGUS including immune phenotype.

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e19537 Background: Monoclonal Gammopathy of Undetermined Significance (MGUS) is a benign precursor of multiple myeloma (MM). Individuals with MGUS have an overall 1% risk per year of disease progression to active MM or other cancers, although risk varies depending on multiple factors. Natural killer (NK) cells, cytotoxic CD8+ T cells, and dendritic cells have been shown to be altered in MM. Immune profile analysis can help to understand the microenvironment for monoclonal plasma cells better and help identify early factors for progression of MGUS into MM. Methods: We conducted a retrospective review of individuals from 2007-2023 who had a confirmed MGUS diagnosis and available flow-cytometry based immunophenotyping of peripheral blood. Demographics, Charlson Comorbidity Index (CCI), immunoglobulin subtype, date of diagnosis and progression, CD4/CD8 T-cell ratio, CD19+ B-cells, memory B-cells, gamma delta T cells, NK cells, and exhausted/non-exhausted CD4+ and CD8+ T cells were characterized. Descriptive statistics were expressed as means and standard deviations for continuous variables and tabulated frequencies for categorical variables. Pearson’s chi-square test of independence was used to explore the relationship between categorical race and diagnosis across categorical variables. Analysis of variance was utilized to assess the variation in continuous variables by race and diagnosis. The investigation of overall survival (OS) and progression-free survival (PFS) involved using univariate and multivariate Cox models across all pertinent variables. Hazard ratios (HRs) were estimated. A stepwise regression model was incorporated into the Cox multivariate model for a comprehensive analysis. All statistical tests were tested at alpha=0.05. Results: This retrospective study analyzed 151 patients, 84 (55.6%) being male. Average age was 55-77.8 years. The primary sub-diagnosis included IgG kappa at 30.5%, followed by IgG lambda at 29.8%. No significant associations were observed between MGUS subtype and comorbidities, race and Immunoglobulin subtype, Mayo risk status, and free light chain ratio (FLCR). After median follow-up of 666 days, median PFS was 8.07 years with a 95% CI of (4.45, 14.68), and median OS exceeded 12.71 years. The Univariate model for PFS identified the CCI Score (p=0.003, HR=1.25), FLCR (p=0.012, HR=1.024), and NK T-cells (%gated) (p=0.0211, HR=1.033) as significant factors. Only the CCI score was retained in the multivariate stepwise model. Univariate model for OS revealed associations with CCI (p<0.001, HR=1.50), NK T-cells (%gated) (p=0.007, HR=1.05), monoclonal protein (p=0.008, HR=2.80), Non-exhausted T-cells-CD4 (% of CD4+) (p=0.013, HR=0.96), and age (p=0.023, HR=1.09). Conclusions: In this single-center retrospective review, only CCI remained prognostically significant in the multivariate model. CCI and NK T-cells were prognostically significant for OS in the univariate analysis.

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