中国癌症杂志2026，Vol.36Issue(3)：251-257,7.DOI:10.19401/j.cnki.1007-3639.2026.03.005
系统性淋巴结清扫术对晚期卵巢癌患者生存影响的模拟随机对照试验研究
A target trial emulation study on the impact of systemic lymphadenectomy on survival in patients with advanced ovarian cancer
摘要
Abstract
Background and purpose:The survival benefit of lymph node dissection in ovarian cancer remains controversial.The LION study,which focused on populations in Europe and the Americas,has yet to demonstrate clear applicability to Chinese patients.This study,based on our hospital's ovarian cancer cohort,employs target trial emulation(TTE)to estimate the real-world clinical value of lymphadenectomy in the Chinese population.It aims to provide localized evidence to optimize surgical strategies and advance personalized precision therapy.Methods:The study applied a TTE,rigorously defining inclusion criteria,exclusion criteria,treatment strategies and follow-up timepoints to control for selection bias.Participants included newly diagnosed epithelial ovarian cancer patients who underwent radical surgery at Fudan University Shanghai Cancer Center from January 2020 to December 2023.This study was approved by the Ethics Committee of Fudan University Shanghai Cancer Center(approval number:2503-Exp155).Inclusion Criteria:① Pathological type is epithelial ovarian carcinoma;② Postoperative pathological stage is International Federation of Gynecology and Obstetrics(FIGO)ⅡB to Ⅳ;③ Age 18 to 75 years;④ Eastern Cooperative Oncology Group(ECOG)performance status score of 0 to 1.Exclusion Criteria:① Preoperative imaging or intraoperative exploration revealed significantly enlarged or suspicious metastatic lymph nodes;② Surgery did not achieve R0 resection(R0 resection is defined as no macroscopically visible residual tumor within the abdominopelvic cavity);③ Patients who received neoadjuvant therapy;④Patients not receiving first-line treatment for ovarian cancer;⑤ Postoperative follow-up time less than 3 months.The patients were divided into two groups based on whether lymphadenectomy was performed.Data were derived from the Shanghai Ovarian Cancer Specialized Database and hospital follow-up systems,with a follow-up cutoff date of September 30,2025.The primary endpoint was overall survival(OS).Survival curves were analyzed using the Kaplan-Meier method,and intergroup differences were evaluated using the log-rank test.Univariate Cox regression was applied to identify factors influencing OS.The significance level was set to α=0.05 for two-tailed tests,with P<0.05 considered statistically significant.Results:The study included a total of 353 patients(239 in the no lymphadenectomy group and 114 in the lymphadenectomy group).There were no statistically significant differences between the two groups in baseline characteristics such as age,histological type(both groups had 92.1%high-grade serous carcinoma),FIGO stage(stage Ⅲ:73.7%vs 74.1%;stage Ⅳ:17.6%vs 20.2%),genetic mutations[BRCA1/2 mutation rates and homologous recombination deficiency(HRD)positivity],surgical procedures,adjuvant chemotherapy and maintenance therapy(all P>0.05).The follow-up period ranged from 3.0 to 54.7 months.OS analysis showed that the 4-year OS rates for the lymphadenectomy group versus the no lymphadenectomy group were 78.4%vs 80.3%,respectively,with no statistically significant difference between groups(P=0.268).Univariate Cox regression analysis showed that age,FIGO stage and lymph node dissection were not significantly associated with OS(all P>0.05).Conclusion:In China,lymphadenectomy maybe offers limited value for patients who have achieved R0 resection and have no evidence of lymph node metastasis during surgery.Its clinical utility requires further validation based on individualized factors,and future multicenter prospective studies should explore its potential role in specific subgroups.关键词
晚期卵巢癌/系统性淋巴结清扫/模拟随机对照试验/总生存期/Cox回归分析Key words
Advanced ovarian cancer/Systemic lymphadenectomy/Target trial emulation/Overall survival/Cox regression analysis分类
医药卫生引用本文复制引用
柏方,吴光哲,钟燕平,温灏,冯征,居杏珠,吴小华,郭勤浩..系统性淋巴结清扫术对晚期卵巢癌患者生存影响的模拟随机对照试验研究[J].中国癌症杂志,2026,36(3):251-257,7.基金项目
上海申康医院发展中心(SHDC2024CRI085). Shanghai Hospital Development Center(SHDC2024CRI085). （SHDC2024CRI085）
