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早期宫颈癌患者免行系统性盆腔淋巴结清扫的前哨淋巴结活检术：SENTIX前瞻性、单臂、非劣效性国际试验的最终结果

Sentinel lymph node biopsy without systematic pelvic lymphadenectomy in females with early-stage cervical cancer: final outcome of the SENTIX prospective, single-arm, noninferiority, international trial

原文发布日期：2025-07-04

英文摘要：

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文章 :

早期宫颈癌患者免行系统性盆腔淋巴结清扫的前哨淋巴结活检术：SENTIX前瞻性、单臂、非劣效性国际试验的最终结果

Sentinel lymph node biopsy without systematic pelvic lymphadenectomy in females with early-stage cervical cancer: final outcome of the SENTIX prospective, single-arm, noninferiority, international trial

原文发布日期：2025-07-04

英文摘要：

Sentinel lymph node (SLN) biopsy with ultrastaging is standard in endometrial and vulvar cancers, whereas systematic pelvic lymphadenectomy (PLND) remains recommended in cervical cancer. The SENTIX trial prospectively evaluated the safety of SLN biopsy without PLND in early-stage cervical cancer. Female patients, International Federation of Gynaecology and Obstetrics 2018 stage IA1/LVSI+ to IB2 disease, were enrolled between 2016 and 2020 across 47 sites in 18 countries. All underwent SLN biopsy followed by hysterectomy/trachelectomy. Patients with undetected, unilateral or intraoperatively metastatic SLNs were excluded from the intention-to-treat cohort. SLNs were assessed by pathological ultrastaging. Of 731 patients enrolled, 594 formed the intention-to-treat cohort. SLN metastases were identified in 82 patients (12%), 56.1% intraoperatively and 43.9% by ultrastaging. At 2 years, the recurrence rate was 6.1% (one-sided 95% CI 7.9%), confirming noninferiority to the 7% reference rate. Two-year disease-free and overall survival rates were 93.3% (95% CI 94.9–91.6) and 97.9% (95% CI 98.9–97.0), respectively. Here we show that SLN biopsy without systematic PLND did not increase the risk of recurrence in patients with early-stage cervical cancer. Pathological ultrastaging of SLNs detected about 44% of N1 cases, which would be missed by a standard lymph node assessment. Trial registration: ClinicalTrials.gov (NCT02494063).

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前哨淋巴结（SLN）活检联合超分期病理检查已成为子宫内膜癌和外阴癌的标准术式，而系统性盆腔淋巴结清扫术（PLND）目前仍是宫颈癌的推荐术式。SENTIX试验前瞻性评估了早期宫颈癌中省略PLND仅行SLN活检的安全性。该研究纳入2016至2020年间来自18个国家47个中心的女性患者，国际妇产科联盟（FIGO）2018分期为IA1/LVSI+至IB2期。所有患者均接受SLN活检后行子宫切除术/宫颈切除术。术中未检出SLN、单侧SLN或存在转移的患者被排除在意向治疗人群外。SLN采用病理超分期评估。在入组的731例患者中，594例构成意向治疗人群。82例（12%）检出SLN转移，其中56.1%为术中检出，43.9%通过超分期确诊。2年复发率为6.1%（单侧95%CI 7.9%），证实不劣于7%的预设参考值。2年无病生存率和总生存率分别为93.3%（95%CI 94.9-91.6）和97.9%（95%CI 98.9-97.0）。本研究表明，早期宫颈癌患者省略系统性PLND仅行SLN活检不会增加复发风险。SLN超分期病理检查可检出约44%的N1期病例，而标准淋巴结评估会遗漏这些转移灶。试验注册号：ClinicalTrials.gov（NCT02494063）。