Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Unità di Ginecopatologia e Patologia Mammaria, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Unità di Ginecologia Oncologica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Int J Gynecol Cancer. 2020 Dec;30(12):1871-1877. doi: 10.1136/ijgc-2020-001710. Epub 2020 Oct 30.
We compared ultrastaging and one-step nucleic acid amplification (OSNA) examination of sentinel lymph nodes in two homogeneous patient populations diagnosed with early stage cervical cancer. The primary aim of our study was to evaluate the rate and type of sentinel lymph node metastases detected by ultrastaging and OSNA assay. Secondary aims were to define the sensitivity and the negative predictive value of sentinel lymph node biopsy assessed with OSNA and ultrastaging and to define the role of sentinel lymph node assessment in predicting non-sentinel lymph node status.
Consecutive patients who underwent surgery (radical hysterectomy or trachelectomy or cervical conization) at our institution, between January 2018 and March 2020, were enrolled. All patients had a preoperative diagnosis of early-stage cervical carcinoma (International Federation of Gynecology and Obstetrics (FIGO) 2018 stages IA-IIB) and underwent sentinel lymph node assessment with ultrastaging or OSNA. Patients with advanced FIGO stages and special histology subtypes (other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma) or patients with sentinel lymph nodes analyzed only with hematoxylin and eosin were excluded. Clinical data were compared using the χ test and Fisher's exact test. A κ coefficient was determined with respect to lymph node assessment. A p value <0.05 was considered statistically significant.
A total of 116 patients were included in this retrospective analysis (53 ultrastaging, 63 OSNA). Overall, 531 and 605 lymph nodes were removed in the ultrastaging and OSNA groups, respectively, and 140 and 129 sentinel lymph nodes were analyzed in the ultrastaging and OSNA groups, respectively. 22 patients had metastatic sentinel lymph nodes: 6 (11.3%) of 53 patients in the ultrastaging group and 16 (25.4%) of 63 patients in the OSNA group. The total amount of positive SLNs was 7 (5%) of 140 in the ultrastaging group and 21 (16.3%) of 129 in the OSNA group, respectively (p=0.0047). Pelvic lymphadenectomy was performed in 26 (49.1%) of 53 patients in the ultrastaging group and in 34 (54%) of 63 patients in the OSNA group due to comorbidities. Metastatic non-sentinel lymph nodes were found in 4 patients: 2 (7.7%) of 26 patients in the ultrastaging group and 2 (5.9%) of 34 patients in the OSNA group, respectively. The total amount of positive pelvic lymph nodes was 3 (0.6%) of 531 in the ultrastaging group and 4 (0.7%) of 605 in the OSNA group (p=0.61). In the OSNA group, only 2 patients with negative sentinel lymph nodes had metastatic disease in the pelvic lymph nodes. By contrast, no patients with OSNA-positive sentinel lymph nodes had metastases in the pelvic lymph nodes. In the ultrastaging group, all patients with negative sentinel lymph nodes did not have metastatic disease in other pelvic lymph nodes.
OSNA assessment of sentinel lymph nodes was associated with a negative predictive value of 91% but poor reliability in detecting node metastases in non-sentinel pelvic lymph nodes. Of note, the ultrastaging protocol revealed higher sensitivity and more reliability in predicting pelvic non-sentinel lymph node status.
我们比较了两种同质宫颈癌患者人群中前哨淋巴结的超微结构分期和一步法核酸扩增（OSNA）检测。本研究的主要目的是评估超微结构分期和 OSNA 检测法检测到的前哨淋巴结转移的发生率和类型。次要目的是定义 OSNA 和超微结构分期评估的前哨淋巴结活检的敏感性和阴性预测值，并定义前哨淋巴结评估在预测非前哨淋巴结状态中的作用。
连续纳入我院 2018 年 1 月至 2020 年 3 月间行手术治疗（根治性子宫切除术或广泛子宫切除术或宫颈锥切术）的患者。所有患者术前诊断为早期宫颈癌（国际妇产科联盟 2018 年分期[FIGO]IA-IIB 期），并接受超微结构分期或 OSNA 前哨淋巴结评估。排除晚期 FIGO 分期和特殊组织学亚型（非鳞状细胞癌、腺癌或腺鳞癌）的患者或仅用苏木精和伊红染色分析的前哨淋巴结的患者。使用 χ 检验和 Fisher 确切检验比较临床数据。用 κ 系数评估淋巴结评估。p 值<0.05 被认为具有统计学意义。
本回顾性分析共纳入 116 例患者（53 例超微结构分期，63 例 OSNA）。超微结构分期组共切除 531 个和 605 个淋巴结，OSNA 组分别切除 605 个和 605 个淋巴结，分别分析 140 个和 129 个前哨淋巴结。22 例患者有转移的前哨淋巴结：超微结构分期组 6 例（11.3%），OSNA 组 16 例（25.4%）。超微结构分期组 7 例（5%）和 OSNA 组 21 例（16.3%）的总阳性 SLNs 分别为阳性（p=0.0047）。由于合并症，超微结构分期组 26 例（49.1%）和 OSNA 组 34 例（54%）行盆腔淋巴结清扫术。4 例患者发现转移性非前哨淋巴结：超微结构分期组 2 例（7.7%），OSNA 组 2 例（5.9%）。超微结构分期组 3 例（0.6%）和 OSNA 组 4 例（0.7%）的总阳性盆腔淋巴结分别为阳性（p=0.61）。在 OSNA 组中，只有 2 例阴性前哨淋巴结的患者有盆腔淋巴结的转移疾病。相比之下，没有 OSNA 阳性前哨淋巴结的患者有盆腔淋巴结转移。在超微结构分期组中，所有阴性前哨淋巴结的患者均无其他盆腔淋巴结转移疾病。
OSNA 评估前哨淋巴结具有 91%的阴性预测值，但在检测非前哨性盆腔淋巴结转移方面可靠性较差。值得注意的是，超微结构分期方案在预测盆腔非前哨淋巴结状态方面具有更高的敏感性和可靠性。
