Guenther J Michael, Ward Andrew, Martin Brian J, Cripe Mark, Sharma Rohit, Leong Stanley P, Clark Joseph I, Hamner John, Beard Timothy
St. Elizabeth Physicians General & Vascular Surgery, Edgewood, KY, USA.
University of Tennessee Medical Center, Knoxville, TN, USA.
World J Surg Oncol. 2025 Jan 3;23(1):5. doi: 10.1186/s12957-024-03640-x.
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.
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.
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).
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.
美国国立综合癌症网络指南建议，前哨淋巴结活检（SLNB）适用于前哨淋巴结转移风险>10%的患者；对于风险为5%-10%的患者，可考虑行SLNB；风险<5%的患者则无需进行。整合31基因表达谱（i31-GEP）算法将31-GEP与临床病理变量相结合，用于评估前哨淋巴结转移风险。
在一项前瞻性、多中心DECIDE研究（n = 322）纳入的T1-T2期肿瘤患者中，评估i31-GEP对SLNB风险的预测准确性。为确定将i31-GEP纳入决策是否会减少SLNB的实施数量，采用倾向评分匹配法，与一组未使用31-GEP进行SLNB决策的不重叠队列进行比较。
i31-GEP预测风险<5%的患者中，无前哨淋巴结转移阳性病例（0/35）。倾向评分匹配显示，SLNB的实施数量减少了18.5%（43.7%对62.2%，p<0.001）。i31-GEP可减少25.0%的不必要活检（35/140）。
这项前瞻性研究证实了i31-GEP在SLNB中的性能和临床应用价值，有助于优化风险适配治疗；同时表明，将i31-GEP纳入临床决策可显著降低SLNB的实施率。
