Bizzarri Nicolò, Schivardi Gabriella, Di Martino Giampaolo, Antonacci Alessia, Querleu Denis, Pedone Anchora Luigi, Ferrandina Gabriella, Fedele Camilla, Carbone Vittoria, Casarin Jvan, Buda Alessandro, Zanagnolo Vanna, Multinu Francesco, Testa Filippo, Landoni Fabio, Scambia Giovanni, Fanfani Francesco
UOC Ginecologia Oncologica, Dipartimento di Scienze Della Salute Della Donna, Del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.
Department of Gynecology, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Eur J Surg Oncol. 2025 Jul;51(7):109981. doi: 10.1016/j.ejso.2025.109981. Epub 2025 Mar 20.
The primary aim of this study was to assess the factors associated with bilateral mapping failure in patients with apparent early-stage cervical cancer undergoing sentinel lymph node (SLN) biopsy using indocyanine green (ICG). Secondary aims were sensitivity, negative predictive value and lymph node recurrence.
Retrospective multi-center study. Patients with cervical cancer apparent FIGO stage IA1 to IIA2, treated with primary surgery between 04/2015 and 12/2023 and undergoing SLN mapping attempt with ICG injection, were included. Appropriate statistical analysis was performed to assess study endpoints. Timeframe was divided in first period 04/2015-12/2019 and second period 01/2020-12/2023.
618 patients were included. Bilateral SLN mapping was achieved in 531 (85.9 %) women (36 of them, 5.8 %, underwent cervical re-injection of ICG). SLN unilateral mapping and mapping failure was observed in 71 (11.5 %) and 16 (2.6 %), respectively. The sensitivity, negative predictive value and accuracy were 85.9 %, 98.1 % and 98.3 %, respectively. False negative rate was 4/68 (5.9 %) in patients with unilateral mapping versus 6/316 (1.9 %) in those with bilateral mapping (p = 0.061). BMI>30 (p = 0.001) and pathologic tumor diameter >20 mm (p = 0.023) were the only factors independently associated with bilateral SLN mapping failure. ICG re-injection increased the rate of bilateral SLN detection from 81.3 % to 85.9 %. The rate of bilateral detection was 82.8 % versus 88.3 % in the first versus second study period, respectively (p = 0.061). 3-year DFS and OS in all patients were 89.7 % and 98.2 %, respectively. Seven patients (1.2 %) had lymph node recurrence in the group of any SLN mapping versus 1 (6.3 %) in no mapping group (p = 0.190).
High BMI and larger tumors were associated with bilateral SLN mapping failure using ICG. The ICG cervical re-injection increased the rate of bilateral mapping. No lymph node recurrence difference was found in patients undergoing SLN mapping versus patients with mapping failure.
本研究的主要目的是评估在使用吲哚菁绿（ICG）进行前哨淋巴结（SLN）活检的早期宫颈癌患者中，与双侧定位失败相关的因素。次要目的是敏感性、阴性预测值和淋巴结复发情况。
回顾性多中心研究。纳入2015年4月至2023年12月期间接受初次手术且通过ICG注射进行SLN定位尝试的国际妇产科联盟（FIGO）分期为IA1至IIA2期的宫颈癌患者。进行适当的统计分析以评估研究终点。时间范围分为第一阶段（2015年4月至2019年12月）和第二阶段（2020年1月至2023年12月）。
共纳入618例患者。531例（85.9%）女性成功完成双侧SLN定位（其中36例，5.8%，接受了宫颈ICG再次注射）。分别有71例（11.5%）和16例（2.6%）出现SLN单侧定位和定位失败。敏感性、阴性预测值和准确性分别为85.9%、98.1%和98.3%。单侧定位患者的假阴性率为4/68（5.9%），而双侧定位患者为6/316（1.9%）（p = 0.061）。BMI>30（p = 0.001）和病理肿瘤直径>20 mm（p = 0.023）是与双侧SLN定位失败独立相关的唯一因素。ICG再次注射使双侧SLN检测率从81.3%提高到85.9%。在第一个和第二个研究阶段，双侧检测率分别为82.8%和88.3%（p = 0.061）。所有患者的3年无病生存率（DFS）和总生存率（OS）分别为89.7%和98.2%。在任何SLN定位组中，7例患者（1.2%）出现淋巴结复发，而在未进行定位组中为1例（6.3%）（p = 0.190）。
高BMI和较大肿瘤与使用ICG进行双侧SLN定位失败相关。ICG宫颈再次注射提高了双侧定位率。在接受SLN定位的患者与定位失败的患者中，未发现淋巴结复发差异。
