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Войти в исследования Journal of surgical oncology · 2026
Universal Risk Stratification in Stage I-III Cutaneous Melanoma Using 31-gene Expression Profiling: A Single-Center Study.
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Gehle Daniel B, Morgan Philip W, Fitts Emme M, Hauser Nathaniel L, Olson Chelsea R, Fleming Andrew M, Freitas Julia Pedo, Liu-Smith Feng, Nouer Simonne S, Murphy Andrew J, Fleming Martin D
Аннотация
BACKGROUND: Patients with early-stage cutaneous melanoma (CM) have low individual risk but account for most distant recurrences. The utility of gene expression profiling (GEP) in CM risk stratification and clinical management remains unclear.
METHODS: From 2015 to 2022, CM patients at a single center were universally referred for DecisionDx 31-GEP. Patients with prior recurrence or not undergoing excision were excluded. The Kaplan-Meier method and Cox proportional hazards models were used to evaluate primary outcomes of recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and melanoma-specific survival (MSS). Secondary outcomes were sentinel lymph node biopsy (SLNB) positivity and recurrence subtype events.
RESULTS: 689 patients were analyzed: 63% GEP Class 1A, 16.1% Class 1B/2A, 16.1% Class 2B, and 4.8% unclassified. After staging, 86.6% were stage I/II and 13.4% stage III. Median follow-up was 4.85 years. On multivariable analysis, GEP remained significantly predictive of RFS (Class 1B/2A HR = 4.022; Class 2B HR = 3.052), DMFS (Class 1B/2A HR = 4.403; Class 2B HR = 3.729), and MSS (Class 1B/2A HR = 6.656; Class 2B HR = 11.583) (p < 0.05 for all). Older Class 1A patients with indication for SLNB had lower SLNB positivity (2.8% ≥ 65 years, 0% ≥ 75 years).
CONCLUSIONS: Our data show GEP remains a robust predictor of recurrence and MSS after adjusting for clinicopathologic factors overall but is not predictive for all outcomes in stage-stratified analyses, particularly Stage II disease. Stage IA patients should forgo GEP altogether testing due to its futility in this population. Older patients with low-risk GEP may be candidates for avoidance of SLNB given lower positivity rates. GEP Class 2B patients represent a relatively high-risk population regardless of SLNB status.
METHODS: From 2015 to 2022, CM patients at a single center were universally referred for DecisionDx 31-GEP. Patients with prior recurrence or not undergoing excision were excluded. The Kaplan-Meier method and Cox proportional hazards models were used to evaluate primary outcomes of recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and melanoma-specific survival (MSS). Secondary outcomes were sentinel lymph node biopsy (SLNB) positivity and recurrence subtype events.
RESULTS: 689 patients were analyzed: 63% GEP Class 1A, 16.1% Class 1B/2A, 16.1% Class 2B, and 4.8% unclassified. After staging, 86.6% were stage I/II and 13.4% stage III. Median follow-up was 4.85 years. On multivariable analysis, GEP remained significantly predictive of RFS (Class 1B/2A HR = 4.022; Class 2B HR = 3.052), DMFS (Class 1B/2A HR = 4.403; Class 2B HR = 3.729), and MSS (Class 1B/2A HR = 6.656; Class 2B HR = 11.583) (p < 0.05 for all). Older Class 1A patients with indication for SLNB had lower SLNB positivity (2.8% ≥ 65 years, 0% ≥ 75 years).
CONCLUSIONS: Our data show GEP remains a robust predictor of recurrence and MSS after adjusting for clinicopathologic factors overall but is not predictive for all outcomes in stage-stratified analyses, particularly Stage II disease. Stage IA patients should forgo GEP altogether testing due to its futility in this population. Older patients with low-risk GEP may be candidates for avoidance of SLNB given lower positivity rates. GEP Class 2B patients represent a relatively high-risk population regardless of SLNB status.