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Multicenter Study
. 2025 Apr;14(7):e70839.
doi: 10.1002/cam4.70839.

A Prospective, Multicenter Analysis of Recurrence-Free Survival After Sentinel Lymph Node Biopsy Decisions Influenced by the 31-GEP

J Michael Guenther  1 , Andrew Ward  2 , Brian J Martin  3 , Mark Cripe  4 , Timothy Beard  5 , Oliver Wisco  6 , Rohit Sharma  7 , Stanley P Leong  8 , Richard Essner  9 , Joseph I Clark  10 , John Hamner  11 , Brenda Sickle-Santanello  12 , Maki Yamamoto  13
Affiliations
Multicenter Study

A Prospective, Multicenter Analysis of Recurrence-Free Survival After Sentinel Lymph Node Biopsy Decisions Influenced by the 31-GEP

J Michael Guenther et al. Cancer Med. 2025 Apr.

Abstract

Background: Although most patients with cutaneous melanoma (CM) will have a negative sentinel lymph node biopsy (SLNB), up to 20%-30% of these patients will recur. The 31-gene expression profile (31-GEP) test has been prospectively validated to identify patients at low (Class 1A), intermediate (Class 1B/2A), and high (Class 2B) risk of SLN positivity and recurrence.

Methods: DECIDE is a prospective, multicenter study to assess the effect of 31-GEP testing on SLNB performance rates in patients with T1-T2 tumors considering SLNB and to study long-term outcomes. Here, we assessed outcomes in patients with a Class 1A 31-GEP result (n = 130).

Results: Of Class 1A patients, 63 had an SLNB, with a 3.2% SLN positivity rate (2/63). No Class 1A patients, regardless of SLN status, experienced a recurrence (2-year median follow-up).

Conclusions: These results are consistent with previous studies that showed the 31-GEP can identify patients at low risk of SLN positivity and recurrence.

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Conflict of interest statement

This study was funded by Castle Biosciences Inc. B.J.M. is an employee and stock/options holder at Castle Biosciences Inc. J.M.G. and R.S. are on the Speaker's bureau for Castle Biosciences. Additional authors have no conflicts to declare.

Figures

FIGURE 1
FIGURE 1
Flow chart incorporating 31‐GEP testing into sentinel lymph node biopsy and clinical management decisions for patients with T1–T2 cutaneous melanoma tumors.
See this image and copyright information in PMC

References

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