Clinical Summary

World Journal of Surgical Oncology

January 2025

Prospective multicenter analysis shows the 31-gene expression profile test reduces unnecessary sentinel lymph node biopsies in melanoma patients

REFERENCE

Guenther, J.M., Ward, A., Martin, B.J. et al. A prospective, multicenter analysis of the integrated 31-gene expression profile test for sentinel lymph node biopsy (i31-SLNB) test demonstrates reduced number of unnecessary SLNBs in patients with cutaneous melanoma. World J Surg Onc. 23, 5 (2025). https://doi.org/10.1186/s12957-024-03640-x

  • introduction

    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-SLNB) algorithm combines the 31-GEP with clinicopathologic variables, estimating SLN positivity risk.

  • methods

    The i31-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-SLNB into decision-making resulted in fewer SLNBs performed, propensity score-matching was performed to a non-overlapping cohort for whom the i31-SLNB was not used for SLNB decision-making.

  • results

    No patients with < 5% i31-SLNB 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-SLNB could have reduced the number of unnecessary biopsies by 25.0% (35/140).

  • conclusion

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

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