Altgassen Christopher, Hertel Hermann, Brandstädt Antje, Köhler Christhardt, Dürst Matthias, Schneider Achim
Department of Gynecology and Gynecologic Oncology, Universitätsmedizin Berlin, Charité, Hindenburgdamm 30, D-12203 Berlin, Germany.
J Clin Oncol. 2008 Jun 20;26(18):2943-51. doi: 10.1200/JCO.2007.13.8933.
Single-institution case series have demonstrated the feasibility of the sentinel concept in cervical cancer. However, the diagnostic accuracy remains to be validated. We evaluated detection rate and diagnostic accuracy to predict the histopathologic pelvic nodal status in patients with cervical cancer of all stages.
In a hypothesis-based, prospective, multicenter cohort study, patients underwent lymph node detection after labeling with technetium, patent blue, or both. After systematic pelvic and, if indicated, para-aortic node dissection, all lymph nodes were histopathologically examined. Detection rate, sensitivity, and negative predictive value (NPV) were calculated.
According to the protocol, 590 patients were eligible. Detection rate of pelvic sentinel nodes was 88.6% (95% CI, 85.8% to 91.1%) and was significantly higher for the combination of technetium and patent blue (93.5%; 95% CI, 90.3% to 96.0%). Of 106 patients with pelvic lymph node metastases, 82 had pelvic sentinel node metastases. The overall sensitivity was 77.4% (95% CI, 68.2% to 85.0%), which was lower than 90%, the predefined noninferiority margin (P < .001). Sensitivity in women with tumors <or= 20 mm (90.9%), with bilateral detection (87.2%), or with both substances applied (80.3%) was higher compared with the total population. The overall NPV was 94.3% (95% CI, 91.6% to 96.4%) and was higher in patients with tumors <or= 20 mm (99.1%; 95% CI, 96.6% to 100%) compared with patients with tumors more than 20 mm (88.5%; 95% CI, 82.9% to 92.8%; P < .001).
In our cohort (all stages), sensitivity of the sentinel concept was low. However, patients with tumor diameter <or= 20 mm may profit from this concept.
单机构病例系列研究已证明前哨淋巴结概念在宫颈癌中的可行性。然而，其诊断准确性仍有待验证。我们评估了各期宫颈癌患者预测盆腔淋巴结组织病理学状态的检测率和诊断准确性。
在一项基于假设的前瞻性多中心队列研究中，患者在使用锝、专利蓝或两者标记后进行淋巴结检测。在系统性盆腔淋巴结清扫以及必要时进行腹主动脉旁淋巴结清扫后，对所有淋巴结进行组织病理学检查。计算检测率、敏感性和阴性预测值（NPV）。
根据方案，590例患者符合条件。盆腔前哨淋巴结的检测率为88.6%（95%可信区间，85.8%至91.1%），锝与专利蓝联合使用时检测率显著更高（93.5%；95%可信区间，90.3%至96.0%）。在106例有盆腔淋巴结转移的患者中，82例有盆腔前哨淋巴结转移。总体敏感性为77.4%（95%可信区间，68.2%至85.0%），低于预先设定的非劣效性界值90%（P <.001）。肿瘤直径≤20 mm的女性、双侧检测的女性或使用两种物质的女性的敏感性（分别为90.9%、87.2%、80.3%）高于总体人群。总体NPV为94.3%（95%可信区间，91.6%至96.4%），肿瘤直径≤20 mm的患者的NPV（99.1%；95%可信区间，96.6%至100%）高于肿瘤直径大于20 mm的患者（88.5%；95%可信区间，82.9%至92.8%；P <.001）。
在我们的队列（所有分期）中，前哨淋巴结概念的敏感性较低。然而，肿瘤直径≤20 mm的患者可能从这一概念中获益。
