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Background <p>National Comprehensive Cancer Network guidelines recommend sentinel lymph node biopsy (SLNB) for patients with &gt; 10% risk of positivity, consider SLNB with 5–10% risk, and foregoing with &lt; 5% risk. The integrated 31-gene expression profile (i31-GEP) algorithm combines the 31-GEP with clinicopathologic variables, estimating SLN positivity risk.</p> Methods <p>The i31-GEP SLNB risk prediction accuracy was assessed in patients with T1-T2 tumors enrolled in the prospective, multicenter DECIDE study (<i>n</i> = 322). To determine if incorporating the i31-GEP into decision-making resulted in fewer SLNBs performed, propensity score-matching was performed to a non-overlapping cohort for whom the 31-GEP was not used for SLNB decision-making.</p> Results <p>No patients with &lt; 5% i31-GEP predicted risk had a positive SLNB (0/35). Propensity matching demonstrated an 18.5% reduction in SLNBs performed (43.7% vs. 62.2%. <i>p</i> &lt; 0.001). The i31-GEP could have reduced the number of unnecessary biopsies by 25.0% (35/140).</p> Conclusions <p>This prospective study confirmed the performance and clinical utility of the i31-GEP for SLNB for improving risk-aligned care and demonstrated a significantly reduced SLNB performance rate when incorporating the i31-GEP into clinical decision-making.</p>

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A prospective, multicenter analysis of the integrated 31-gene expression profile test for sentinel lymph node biopsy (i31-GEP for SLNB) test demonstrates reduced number of unnecessary SLNBs in patients with cutaneous melanoma

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  • 发表日期：

    2025年1月3日

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  • J. Michael Guenther,
  • Andrew Ward,
  • Brian J. Martin,
  • Mark Cripe,
  • Rohit Sharma,
  • Stanley P. Leong,
  • Joseph I. Clark,
  • John Hamner,
  • Timothy Beard

摘要

Background

National Comprehensive Cancer Network guidelines recommend sentinel lymph node biopsy (SLNB) for patients with > 10% risk of positivity, consider SLNB with 5–10% risk, and foregoing with < 5% risk. The integrated 31-gene expression profile (i31-GEP) algorithm combines the 31-GEP with clinicopathologic variables, estimating SLN positivity risk.

Methods

The i31-GEP SLNB risk prediction accuracy was assessed in patients with T1-T2 tumors enrolled in the prospective, multicenter DECIDE study (n = 322). To determine if incorporating the i31-GEP into decision-making resulted in fewer SLNBs performed, propensity score-matching was performed to a non-overlapping cohort for whom the 31-GEP was not used for SLNB decision-making.

Results

No patients with < 5% i31-GEP predicted risk had a positive SLNB (0/35). Propensity matching demonstrated an 18.5% reduction in SLNBs performed (43.7% vs. 62.2%. p < 0.001). The i31-GEP could have reduced the number of unnecessary biopsies by 25.0% (35/140).

Conclusions

This prospective study confirmed the performance and clinical utility of the i31-GEP for SLNB for improving risk-aligned care and demonstrated a significantly reduced SLNB performance rate when incorporating the i31-GEP into clinical decision-making.