Fondazione Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology, Dipartimento per le Scienze della Salute della Donna e del Bambino, Roma, Italia; Division of Obstetrics and Gynecology, Department of Maternal, Neonatal, and Infant Health, Ospedale degli Infermi, ASL Biella, Ponderano (Biella), Italia.
Fondazione Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology, Dipartimento per le Scienze della Salute della Donna e del Bambino, Roma, Italia.
Am J Obstet Gynecol. 2019 Oct;221(4):324.e1-324.e10. doi: 10.1016/j.ajog.2019.05.005. Epub 2019 May 10.
Systematic paraaortic and bilateral pelvic lymphadenectomy is the standard of a comprehensive surgical staging in presumed early epithelial ovarian cancer, but no prospective randomized evidence suggests a possible therapeutic value. Moreover, this procedure is associated with potential severe morbidity. The Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial is a prospective study designed to test whether sentinel node detection can accurately predict nodal status in a cohort of women with early epithelial ovarian cancer.
We here present the results of the first part of the Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial, regarding the feasibility of the sentinel lymph node technique and the preliminary findings regarding its safety and accuracy.
The Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial is a prospective, phase II, single-arm study included patients with presumed stages I-II epithelial ovarian cancer planned for immediate or delayed minimally invasive comprehensive staging. The ovarian pedicle is injected with 2 mL of a 1.25 mg/mL indocyanine green solution. The pelvic and lumboaortic retroperitoneum is then accessed and inspected to identify and remove sentinel nodes. After sentinel node procedure, staging is completed including systematic pelvic and paraaortic lymphadenectomy. Assuming a sensitivity of 98.5% in predicting positive sentinel lymph nodes at histology, a pathological lymph node prevalence of 14.2%, a precision of estimate (ie, the maximum marginal error) d = 5%, a type I error α = 0.05, a sample size of 160 patients is needed to test the general hypothesis. Here we present the preliminary results on the first 31 patients enrolled.
Thirty-one patients were included. Sentinel node was identified in 21 patients (detection rate, 67.7%). The detection rate was significantly higher in women undergoing immediate vs delayed staging (88.9% vs 41.7%, P = .003). Four patients had positive nodes. In all the patients with lymphatic dissemination, a positive sentinel node was identified (sensitivity, 100%; false-negative rate, 0%; negative predictive value, 100%). One (3.2%) intra- and 2 (6.5%) postoperative grade I complications occurred.
Our data show that the detection of sentinel node in early epithelial ovarian cancer is low when patients are submitted to delayed-staging surgery. However, sentinel node procedure is feasible and has the potential to provide reliable and useful information on nodal status and may allow the avoidance of systematic lymphadenectomy in the majority of patients.
系统的腹主动脉旁和双侧盆腔淋巴结切除术是疑似早期上皮性卵巢癌全面手术分期的标准，但没有前瞻性随机证据表明其具有潜在的治疗价值。此外，该手术与潜在的严重发病率有关。早期卵巢癌中前哨淋巴结的 Sentinel 试验是一项前瞻性研究，旨在测试前哨淋巴结检测是否可以准确预测队列中患有早期上皮性卵巢癌的女性的淋巴结状态。
我们在此介绍早期卵巢癌中前哨淋巴结的 Sentinel 试验的第一部分结果，该试验涉及前哨淋巴结技术的可行性以及其安全性和准确性的初步发现。
早期卵巢癌中前哨淋巴结的 Sentinel 试验是一项前瞻性、二期、单臂研究，包括计划立即或延迟进行微创全面分期的疑似 I-II 期上皮性卵巢癌患者。卵巢蒂被注射 2 毫升 1.25 毫克/毫升吲哚菁绿溶液。然后进入盆腔和腰主动脉后腹膜腔，以识别和切除前哨淋巴结。在前哨淋巴结手术后，完成分期，包括系统的盆腔和腹主动脉旁淋巴结切除术。假设在组织学上预测阳性前哨淋巴结的敏感性为 98.5%，病理淋巴结患病率为 14.2%，估计精度（即最大边际误差）d=5%，Ⅰ类错误α=0.05，需要 160 名患者进行样本测试来检验一般假设。在这里，我们介绍了前 31 名入组患者的初步结果。
31 名患者入组。21 名患者（67.7%）发现了前哨淋巴结。立即分期与延迟分期相比，前哨淋巴结的检出率显著更高（88.9%与 41.7%，P=0.003）。4 名患者有阳性淋巴结。所有有淋巴扩散的患者均在前哨淋巴结中发现了阳性（敏感性为 100%；假阴性率为 0%；阴性预测值为 100%）。1 例（3.2%）发生了 I 级和 2 例（6.5%）术后 I 级并发症。
我们的数据表明，当患者接受延迟分期手术时，早期上皮性卵巢癌中前哨淋巴结的检测率较低。然而，前哨淋巴结手术是可行的，有可能提供关于淋巴结状态的可靠和有用的信息，并可能允许避免对大多数患者进行系统的淋巴结切除术。
