近日，中山大学癌症中心刘继红团队比较了宫颈癌的哨兵淋巴结活检或淋巴结切除术对患者预后的影响。这一研究成果发表在2025年10月16日出版的《新英格兰医学杂志》上。

与淋巴结切除术相比，单独行前哨淋巴结活检治疗宫颈癌的生存结果数据有限。

在这项多中心、随机、非劣效性试验中，根据2009年国际妇产科学联合会的标准，研究组招募了IA1期（伴有淋巴血管浸润）、IA2期、IB1期或IIA1期宫颈癌患者。手术时进行哨兵淋巴结活检，随后检查冷冻切片。前哨淋巴结阴性的患者术中按1:1的比例被分配不接受盆腔淋巴结切除术（仅活检组）或接受淋巴结切除术（淋巴结切除术组）。所有患者均行子宫切除术，并按照统一方案进行辅助治疗。主要终点是3年无病生存期，在淋巴结切除术组和仅活检组之间差异的置信区间上限中预先指定了5个百分点的非劣效性边际。次要终点包括腹膜后淋巴结复发、癌症特异性生存和手术并发症。

共有838名患者接受了随机分组：420名患者被分配到单纯活检组，418名患者被分配到淋巴结切除术组。中位随访时间为62.8个月。淋巴结切除术组3年无病生存率为94.6%，单纯活检组为96.9%（差异为2.3个百分点；95%可信区间为5.0 ~ 0.5；非劣效性为P<0.001）；单纯活检组的3年癌症特异性生存率为99.2%，淋巴结切除术组为97.8%（竞争风险分析中癌症死亡的风险比为0.37；95% CI为0.15 ~ 0.95）。单纯活检组无患者腹膜后淋巴结复发，淋巴结切除术组有9例（2.2%）。单纯活检组淋巴囊肿的发生率低于淋巴结切除术组（8.3%比22.0%；P<0.001），淋巴水肿（5.2%比19.1%；P<0.001）、感觉异常（4.0%比8.4%；P=0.009）和疼痛（2.6%比7.9%；P=0.001）的发生率也较低。

研究结果表明，在早期宫颈癌患者中，单独行前哨淋巴结活检在无病生存率方面不逊于淋巴结切除术，且并发症较少。

附：英文原文

Title: Sentinel-Lymph-Node Biopsy Alone or with Lymphadenectomy in Cervical Cancer

Author: Hua Tu, He Huang, Yanfang Li, Xiaojun Chen, Chunyan Wang, Min Zheng, Yanna Zhang, Weidong Zhao, Yanling Feng, Ting Wan, Yongwen Huang, Aijun Yu, Weiguo Lu, Jing Xiao, Weiwei Shan, Ping Zhang, Changkun Zhu, Danbo Wang, Hu Zhou, Jibin Li, Beihua Kong, Weiwei Feng, Xipeng Wang, Rongzhen Luo, Xin Huang, Jundong Li, Zejian Lin, Shuzhong Yao, Jihong Liu

Issue&Volume: 2025-10-16

Abstract:

BACKGROUND

Limited data are available on survival outcomes after sentinel-lymph-node biopsy alone as compared with lymphadenectomy in cervical cancer.

METHODS

In this multicenter, randomized, noninferiority trial, we enrolled patients with cervical cancer that was stage IA1 (with lymphovascular invasion), IA2, IB1, or IIA1 according to 2009 International Federation of Gynecology and Obstetrics criteria. Sentinel-lymph-node biopsy was performed at the time of surgery and was followed by examination of frozen sections. Patients who had negative sentinel lymph nodes were intraoperatively assigned in a 1:1 ratio not to undergo pelvic lymphadenectomy (the biopsy-only group) or to undergo lymphadenectomy (the lymphadenectomy group). All the patients underwent hysterectomy, and adjuvant therapy was provided according to a unified protocol. The primary end point was disease-free survival at 3 years, with a prespecified noninferiority margin of 5 percentage points in the upper limit of the confidence interval for the difference between the lymphadenectomy group and the biopsy-only group. Secondary end points included retroperitoneal nodal recurrence, cancer-specific survival, and surgical complications.

RESULTS

A total of 838 patients underwent randomization: 420 patients were assigned to the biopsy-only group and 418 to the lymphadenectomy group. The median follow-up was 62.8 months. The 3-year disease-free survival was 94.6% in the lymphadenectomy group and 96.9% in the biopsy-only group (difference, 2.3 percentage points; 95% confidence interval [CI], 5.0 to 0.5; P<0.001 for noninferiority); the 3-year cancer-specific survival was 99.2% in the biopsy-only group and 97.8% in the lymphadenectomy group (hazard ratio for death from cancer in competing-risks analysis, 0.37; 95% CI, 0.15 to 0.95). Retroperitoneal nodal recurrences occurred in no patients in the biopsy-only group and in 9 patients (2.2%) in the lymphadenectomy group. The biopsy-only group had a lower incidence of lymphocyst than the lymphadenectomy group (8.3% vs. 22.0%; P<0.001), as well as a lower incidence of lymphedema (5.2% vs. 19.1%; P<0.001), paresthesia (4.0% vs. 8.4%; P=0.009), and pain (2.6% vs. 7.9%; P=0.001).

CONCLUSIONS

In patients with early-stage cervical cancer, sentinel-lymph-node biopsy alone was noninferior to lymphadenectomy with respect to disease-free survival and was associated with fewer complications.

DOI: NJ202510163931507

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2506267