Gynecologic Oncology Center, Department of Gynecology, Obstetrics and Neonatology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.
Department of Special Operative and Oncologic Gynaecology, Asklepios-Clinic Hamburg, Hamburg, Germany.
Gynecol Oncol. 2024 Sep;188:83-89. doi: 10.1016/j.ygyno.2024.06.015. Epub 2024 Jun 27.
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.
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.
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%).
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.
NCT02494063 (ClinicalTrials.gov).
报告 SLN 分期在 SENTIX 国际前瞻性 SLN 活检研究中的结果，该研究针对宫颈癌患者，采用强化超微分期方案和中央质量控制，并评估病理评估的强度与 SLN 中转移检测率的相关性。
符合条件的患者为 T1a1/LVSI+至 T1b2 期（<4cm，保留生育功能者<2cm）、常见肿瘤类型、影像学无可疑淋巴结且双侧 SLN 可检测的宫颈癌患者。术中对 SLN 进行检查，并采用强化超微分期方案（石蜡块以 150-μm 的间隔/水平完全切片）进行处理。来自每个部位的 SLN 均提交进行中央质量控制。
在 SENTIX SLN 研究中，647 名入组的 733 名患者接受了 SLN 超微分期，其中 12.5%（81/647）为淋巴结阳性、N1 病例。术中检测发现这些病例中有 56.8%（46/81）存在转移，分为大转移（83.7%）、微转移（26.3%）和孤立肿瘤细胞（9.1%）。超微分期在 43.2%（35/81）的患者中发现了额外的转移受累，详细切片显示 20 例（24.7%）在第 1 水平有转移（MAC/MIC），9 例（11.1%）在第 2-4 水平有转移，6 例（7.4%）在水平≥5 有转移。
SLN 超微分期通过影像学和术中病理评估检测到阴性淋巴结的患者中额外的 43%的 N1（MAC/MIC）。阳性 SLN 的检测率与超微分期的强度（水平数）相关。从石蜡块检查 4 个水平可检测到>90%的 N1 患者，这是国际超微分期标准的合理妥协。
NCT02494063（ClinicalTrials.gov）。
