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TCL-1507: Molecular and Pathologic Staging Gaps in Mycosis Fungoides and Sézary Syndrome: Real-World Evidence From the LEO-MER Prospective Cohort
Abstract   Peer reviewed

TCL-1507: Molecular and Pathologic Staging Gaps in Mycosis Fungoides and Sézary Syndrome: Real-World Evidence From the LEO-MER Prospective Cohort

Muhammad Saad Hamid, Ashley McCook-Veal, Jeffrey Switchenko, Neha Mehta-Shah, Neha Akkad, Luis Malpica, Danielle Wallace, Jia Ruan, Saja Asakrah, Melissa Larson, …
Clinical lymphoma, myeloma and leukemia, Vol.26, pp.S1046-S1046
08/2026
DOI: 10.1016/S2152-2650(26)02812-0

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Abstract

Background: Real-world adherence to comprehensive molecular and pathologic staging in MF and Sézary syndrome (SS) remains poorly characterized. Using the prospective, multicenter LEO-MER cohort, we examined staging completeness focusing on T-cell clonality assessment and nodal evaluation and their impact on treatment decisions and survival. Methods: Adult patients with confirmed MF or SS enrolled in the LEO-MER cohort (NCT02736357) across eight US academic centers from 2002–2020 were included (n = 177). Primary objectives included characterizing the frequency and completeness of staging assessments, identification of factors associated with first-line (1L) systemic therapy initiation within 12 months, and evaluation of OS and its associated prognostic factors. Results: Among 177 MF/SS patients (median age, 64 years; 58.2% male; 16.4% Black), 62.7% presented with earlystage (ES) and 37.3% with advanced-stage (AS) disease. Black patients were disproportionately represented at advanced presentation (27.3% vs 9.9%, P = 0.004). Blood TCR clonality testing was performed in only 57.7% of ES and 69.7% of AS patients. Skin-toblood clonality matching required by ISCL/EORTC guidelines to confirm malignant blood involvement was attempted in only 27.9% of ES cases and confirmed in just 12.6%. A pathologist survey across LEO-MER sites revealed marked interinstitutional variability in flow cytometry panel composition and TCR methodology, with at least one site lacking a documented approach entirely. Lymph node biopsy was performed in only 6.4% of ES and 52.3% of AS patients, with pathologic nodal assessment obtained in only 11.1% of Nx patients. Stage-specific treatment patterns were broadly guideline concordant, though novel agents were infrequently used as 1L therapy. On multivariable analysis, Nx status (OR, 4.58; P = 0.009) and N2/N3 disease (OR, 4.74; P = 0.034) independently predicted 1L systemic therapy initiation within 12 months. Age >60 years (HR, 2.14; P = 0.018), elevated LDH (HR, 2.02; P = 0.026), N2/N3 disease (HR, 2.65; P = 0.006), and Nx status (HR, 3.19; P = 0.001) were independent adverse prognostic factors for OS. Conclusions: This prospective multicenter study identifies parallel gaps in molecular TCR assessment and pathologic nodal evaluation that independently predict systemic therapy receipt and inferior survival in MF/SS, underscoring the urgent need for standardized staging protocols in cutaneous T-cell lymphoma. HR: hazard ratio; ISCL/EORTC: International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer; LDH: lactate dehydrogenase, MF: mycosis fungoides; Nx: regional lymph nodes cannot be assessed; OR: odds ratio, OS: overall survival; TCR: T-cell receptor.
 health disparities mycosis fungoides T-cell receptor clonality TCL

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