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

作者：H TU, He Huang, Yanfang Li, Xiaojun Chen, Chunyan Wang, Min Zheng, Yanna Zhang, Weidong Zhao, Yanling Feng, Ting Wan, Yongwen Huang, Aijun Yu, Weiguo Lv, 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 · 发表于：New England Journal of Medicine · 年份：2025 · DOI：10.1056/nejmoa2506267 · 被引用次数：25 · 研究领域：Endometrial and Cervical Cancer Treatments、Cervical Cancer and HPV Research、Gynecological conditions and treatments

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-on...