目的:报告SLN分期在SENTIX国际前瞻性试验中对宫颈癌患者进行SLN活检的结果,并评估病理评估的强度与SLN的转移检出率的相关性。
方法:符合资格的患者为T1a1/LVSI至T1b2阶段(<4cm,≤2厘米,用于保留生育力),常见的肿瘤类型,影像学上没有可疑淋巴结,和双边SLN检测。术中检查SLN,并通过强化方案进行超稳定处理(石蜡块以150μm的间隔/水平完全切片)。来自每个站点的SLN被提交用于中央质量控制。
结果:在SENTIXSLN研究中,733名入组患者中有647名接受了SLN超常治疗,确定12.5%(81/647)的节点为阳性,N1病例。术中发现有56.8%(46/81)的转移,分类为大转移(83.7%),微转移(26.3%),和分离的肿瘤细胞(9.1%)。超敏化在43.2%(35/81)的患者中发现了额外的转移受累,详细切片显示转移灶(MAC/MIC)在20例(24.7%)中处于一级,在9例(11.1%)的2-4级,≥5级6例(7.4%)。
结论:通过影像学和术中病理评估,在LN阴性的患者中,SLN超稳定检测到额外的43%的N1(MAC/MIC)。阳性SLN的检出率与超稳定的强度(水平数)相关。从石蜡块检查四个级别,检测到>90%的N1患者,是一个合理的折中超变性国际标准。
背景:NCT02494063(ClinicalTrials.gov)。
OBJECTIVE: To report the outcome of SLN staging in the SENTIX international prospective
trial of SLN biopsy in patients with cervical cancer with an intensive ultrastaging protocol and central quality control and to evaluate how the intensity of pathological assessment correlates with metastatic detection rate in SLNs.
METHODS: Eligible were patients with stages T1a1/LVSI+ to T1b2 (<4 cm, ≤2 cm for fertility sparing), common tumor types, no suspicious lymph nodes on imaging, and bilateral SLN detection. SLNs were examined intraoperatively and processed by an intensive protocol for ultrastaging (paraffin blocks sectioned completely in 150-μm intervals/levels). SLNs from each site were submitted for central quality control.
RESULTS: In the SENTIX SLN
study, 647 out of 733 enrolled patients underwent SLN ultrastaging, identifying 12.5% (81/647) with node positive, N1 cases. Intraoperative detection revealed metastases in 56.8% (46/81) of these cases, categorized into macrometastases (83.7%), micrometastases (26.3%), and isolated tumor cells (9.1%). Ultrastaging identified additional metastatic involvement in 43.2% (35/81) of patients, with detailed sectioning revealing metastases (MAC/MIC) at first level in 20 cases (24.7%), at levels 2-4 in 9 cases (11.1%), and at level ≥5 in 6 cases (7.4%).
CONCLUSIONS: SLN ultrastaging detects additional 43% of N1 (MAC/MIC) in patients with negative LNs by imaging and intraoperative pathological assessment. The detection rate of positive SLN correlates with the intensity (number of levels) of ultrastaging. Examination of four levels from paraffin blocks, which detects >90% of patients with N1, is a reasonable compromise for an international standard for ultrastaging.
BACKGROUND: NCT02494063 (ClinicalTrials.gov).