Background:Radioactive colloids are considered the standard of care for sentinel lymph node (SLN) detection. An alternative detection method using superparamagnetic iron oxide (SPIO) nanoparticles is well documented in breast cancer but poorly studied for gynecological tumors, including vulvar cancer (VC).Objective:Our aim was to evaluate the feasibility, accuracy, and safety of SPIO nanoparticles for SLN mapping in patients with VC as a stand-alone technique compared with the combination of two methods: the standard of care using a radioactive isotope (technetium-99; Tc-99) and SPIO as a new tracer.Methods:We conducted a prospective and observational study of SLN mapping in patients with stage IB VC and tumor size ≤ 4 cm. We calculated detection and malignancy rates per patient and per groin in both study groups. During the 36-month follow-up, the groin recurrence rate was estimated for positive and negative SLNs. Kaplan–Meyer curves were used to analyze the probability of survival, depending on disease-free survival.Results:A total of 110 groins assessed by SLN in 60 patients included in this study were analyzed (70 groins from 40 patients in the group with a single tracer and 40 groins from 20 patients in the group of combined tracers). At least one sentinel lymph node was detected in every patient while the bilateral detection rate was 92.3% for the SPIO group and 88.2% for the Tc-99 and SPIO group. The groin detection rate was 94.3% and 90%, respectively. SLN mapping failure was similar in both groups (2.8% and 2.5%, respectively). During a 3-year follow-up, the isolated groin recurrence rate was 2.1% for negative groins and for disease-free survival it was 28.9 months in the combined tracer group versus 32.8 months in the SPIO group. The Kaplan–Meyer curves showed the increased probability of survival for the SPIO group (87.5%); however, it was insignificant.Conclusions:SLN mapping using the SPIO technique in patients with VC is non-inferior to the combined SPIO and Tc-99 method.
背景：放射性胶体被认为是前哨淋巴结（SLN）检测的标准方法。使用超顺磁性氧化铁（SPIO）纳米颗粒的替代检测方法在乳腺癌中已有充分文献记载，但在包括外阴癌（VC）在内的妇科肿瘤中研究甚少。 目的：本研究旨在评估SPIO纳米颗粒作为独立技术用于VC患者SLN定位的可行性、准确性和安全性，并与两种方法联合应用进行比较：即采用放射性同位素（锝-99；Tc-99）的标准方法与新型示踪剂SPIO的联合方案。 方法：我们对肿瘤大小≤4 cm的IB期VC患者进行了前瞻性观察性SLN定位研究。计算两组研究中每位患者及每个腹股沟区域的检出率和恶性率。在36个月的随访期间，评估了SLN阳性与阴性患者的腹股沟复发率。采用Kaplan-Meier曲线分析基于无病生存期的生存概率。 结果：本研究共纳入60例患者的110个腹股沟SLN检测结果进行分析（单示踪剂组40例患者70个腹股沟，联合示踪剂组20例患者40个腹股沟）。所有患者均至少检测到一个前哨淋巴结，其中SPIO组双侧检出率为92.3%，Tc-99联合SPIO组为88.2%。腹股沟区域检出率分别为94.3%和90%。两组SLN定位失败率相近（分别为2.8%和2.5%）。在3年随访期间，阴性腹股沟区域的孤立复发率为2.1%，联合示踪剂组的无病生存期为28.9个月，而SPIO组为32.8个月。Kaplan-Meier曲线显示SPIO组生存概率较高（87.5%），但差异无统计学意义。 结论：在VC患者中采用SPIO技术进行SLN定位不劣于SPIO联合Tc-99的方法。
肿瘤(癌症)患者之家