UNASSIGNED:31基因表达谱测试(1A类:低风险;1B/2A:中等风险;2B:高风险)已得到验证,以识别可以安全放弃前哨淋巴结活检(SLNB)的皮肤黑色素瘤患者。本研究的目的是量化临床医生使用31-GEP减少SLNB。
未经批准:外科肿瘤学家看到了符合SLNB的T1-T2肿瘤患者(89.1%),皮肤科医生(7.8%),和医学肿瘤学家(3.1%)。在收到31-GEP结果后,但在SLNB之前,临床医生被问及哪些临床和病理特征影响SLNB决策(n=191).使用精确二项检验将SLNB手术率与当代研究(78%SLNB基线率)进行比较。Logistic回归建模(比值比[OR],95%CI)用于识别与SLNB手术率相关的特征。
UNASSIGNED:100个临床决定(52.4%)受到31-GEP的影响,以放弃SLNB,而70%(70/100)未进行。在表演的30人中,0%(0/30)呈阳性。31-GEP影响了63个临床决策(33.0%)进行SLNB,92.1%(58/63)。相对于基线率78.0%(p<0.01),在具有1A级结果的患者中进行的SLNBs的临床上有意义的降低29.4%。在≥55岁或≥65岁的患者中,SLNB减少32.3%(p<0.01),28.3%(p<0.01),分别。总的来说,85.3%与SLNB相关的决策受到31-GEP结果的影响。
未经批准:在此前瞻性中,多中心研究,临床医生证明了31-GEP测试在T1-T2肿瘤患者中放弃或追求SLNB的临床意义,SLNB的风险适当降低。
The 31-gene expression profile test (Class 1A: low-risk; 1B/2A: intermediate-risk; 2B: high-risk) is validated to identify patients with cutaneous melanoma who can safely forego sentinel lymph node biopsy (SLNB). The objective of the current
study is to quantify
SLNB reduction by clinicians using 31-GEP.
Patients with T1-T2 tumors eligible for SLNB were seen by surgical oncologists (89.1%), dermatologists (7.8%), and medical oncologists (3.1%). After receiving 31-GEP results but before SLNB, clinicians were asked which clinical and pathological features influenced
SLNB decisions (n = 191). The Exact binomial test was used to compare
SLNB procedure rates to a contemporary
study (78%
SLNB baseline rate). Logistic regression modeling (odds ratio [OR], 95% CI) was used to identify features associated with SLNB procedure rates.
One hundred clinical decisions (52.4%) were influenced by the 31-GEP to forego SLNB and 70% (70/100) were not performed. Of the 30 performed, 0% (0/30) were positive. The 31-GEP influenced sixty-three clinical decisions (33.0%) to perform SLNB, and 92.1% (58/63) were performed. There was a clinically meaningful 29.4% reduction of SLNBs performed in patients with a Class 1A result relative to the baseline rate of 78.0% (p < .01). In patients ≥55 or ≥65-year-old, SLNB reduction was 32.3% (p < .01), 28.3% (p < .01), respectively. Overall, 85.3% of decisions relating to
SLNB were influenced by 31-GEP results.
In this prospective, multicenter
study, clinicians demonstrated clinically meaningful use of the 31-GEP test to forego or pursue SLNB in patients with T1-T2 tumors resulting in a significant, risk appropriate decrease in SLNBs.