Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO)
Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO)
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DOI：
10.1016/s1470-2045(11)70070-5
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发表时间：
2011-05-01
期刊：
影响因子：
51.1
通讯作者：
Darai, Emile
中科院分区：
文献类型：
--
作者：
Ballester, Marcos;Dubernard, Gil;Darai, Emile
背景 回顾性单中心系列研究表明前哨淋巴结（SLN）鉴定子宫内膜癌的可行性。我们进行了一项前瞻性、多中心队列研究，以评估 SLN 手术预测早期子宫内膜癌患者病理性盆腔淋巴结状态的检出率和诊断准确性。方法对国际妇产科联合会 (FIGO) I-II 期子宫内膜癌患者进行盆腔 SLN 评估，通过宫颈双注射（锝和专利蓝）和系统性盆腔淋巴结解剖。所有淋巴结均进行组织病理学检查，SLN 连续切片并通过免疫化学检查。主要终点是评估每个半骨盆前哨淋巴结活检的阴性预测值（NPV）。这是一项正在进行的研究，招募已经结束。该研究在ClinicalTrials.gov 注册，编号NCT00987051。调查结果从2007 年7 月5 日到2009 年8 月4 日，法国9 个中心招募了133 名患者。注射锝胶体后未出现并发症，注射专利蓝后未出现过敏反应。 SLN 活检期间没有报告手术并发症，包括涉及转换为开放手术的手术。在 125 名符合条件的患者中，有 111 名患者至少检测到 1 个前哨淋巴结。 111 例中有 19 例（17%）有盆腔淋巴结转移。 111 名患者中有 5 名 (5%) 在主动脉旁区域有相关的 SLN。考虑半骨盆作为分析单位，NPV 为 100% (95% CI 95-100)，敏感性为 100% (63-100)。将患者作为分析单位，三名患者出现假阴性结果（两名患者在对侧骨盆区域有转移淋巴结，一名在主动脉旁区域），NPV 为 97% (95% CI 91-99)，敏感性为 84% (62-95)。这三名患者均患有 2 型子宫内膜癌。在 111 名检测到 SLN 的患者中，免疫组织化学和连续切片检测到常规组织学未诊断的转移，占 19 名转移患者中的 9 名 (47%)（8%）。 SLN 活检对 10% 的低风险子宫内膜癌患者和 15% 的中风险子宫内膜癌患者进行了分期。解释 对于低风险或中风险子宫内膜癌患者，采用宫颈双重标记的 SLN 活检可能是系统性淋巴结切除术和完全不进行解剖之间的权衡。此外，我们的研究表明前哨淋巴结活检可以为制定辅助治疗提供重要数据。
Background Retrospective single-centre series have shown the feasibility of sentinel lymph-node (SLN) identification in endometrial cancer. We did a prospective, multicentre cohort study to assess the detection rate and diagnostic accuracy of the SLN procedure in predicting the pathological pelvic-node status in patients with early stage endometrial cancer.Methods Patients with International Federation of Gynecology and Obstetrics (FIGO) stage I-II endometrial cancer had pelvic SLN assessment via cervical dual injection (with technetium and patent blue), and systematic pelvic-node dissection. All lymph nodes were histopathologically examined and SLNs were serial sectioned and examined by immunochemistry. The primary endpoint was estimation of the negative predictive value (NPV) of sentinel-node biopsy per hemipelvis. This is an ongoing study for which recruitment has ended. The study is registered with ClinicalTrials.gov, number NCT00987051.Findings From July 5, 2007, to Aug 4, 2009, 133 patients were enrolled at nine centres in France. No complications occurred after injection of technetium colloid and no anaphylactic reactions were noted after patent blue injection. No surgical complications were reported during SLN biopsy, including procedures that involved conversion to open surgery. At least one SLN was detected in 111 of the 125 eligible patients. 19 of 111 (17%) had pelvic-lymph-node metastases. Five of 111 patients (5%) had an associated SLN in the para-aortic area. Considering the hemipelvis as the unit of analysis, NPV was 100% (95% CI 95-100) and sensitivity 100% (63-100). Considering the patient as the unit of analysis, three patients had false-negative results (two had metastatic nodes in the contralateral pelvic area and one in the para-aortic area), giving an NPV of 97% (95% CI 91-99) and sensitivity of 84% (62-95). All three of these patients had type 2 endometrial cancer. Immunohistochemistry and serial sectioning detected metastases undiagnosed by conventional histology in nine of 111 (8%) patients with detected SLNs, representing nine of the 19 patients (47%) with metastases. SLN biopsy upstaged 10% of patients with low-risk and 15% of those with intermediate-risk endometrial cancer.Interpretation SLN biopsy with cervical dual labelling could be a trade-off between systematic lymphadenectomy and no dissection at all in patients with endometrial cancer of low or intermediate risk. Moreover, our study suggests that SLN biopsy could provide important data to tailor adjuvant therapy.