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OA

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.