基于SEER数据库验证淋巴结清扫术对N0期胆囊癌患者预后的影响

Effect of lymph node dissection on the prognosis for patients with N0 gallbladder cancer based on SEER database

目的基于监测、流行病学和最终结局(SEER)数据库评估淋巴结清扫术对N0期胆囊癌患者预后的影响。方法下载、整理并分析于2004—2015年明确诊断为胆囊癌患者的临床资料,使用R语言将患者分为淋巴结清扫组(LNR)和淋巴结未清扫组(non-LNR),结局指标为肿瘤特异性生存率(CSS)。通过倾向性评分(PSM)保证两组基线资料可比性,采用单因素和多因素Cox回归筛选危险因素并构建相关列线图,Kaplan-Meier法描述生存曲线,Log-rank检验比较生存差异。采用一致性指数(C-index)、ROC曲线和校准曲线对列线图进行评估,同时应用综合判别改善指数(IDI)比较列线图与AJCC分期的临床适用性。结果经PSM,本研究纳入2272例患者。Cox回归筛选出年龄、分化程度、AJCC分期、T分期与LNR为独立危险因素。列线图预测准确性为0.738,标准误为0.007。与AJCC分期相比,模型预测1、3和5年的CSS的IDI分别为0.084、0.111和0.115,具有正改善作用。根据列线图计算得分,Kaplan-Meier法显示高分险与低分险患者的预后差异有统计学意义,有较好的临床实用性。结论淋巴结清扫术可显著改善N0期胆囊癌患者的预后。本文构建的列线图有较好的预测能力,能准确对患者进行危险因素分层,促进个性化诊疗。

objective To evaluate the effect of lymph node dissection on the prognosis for patients with N0 gallbladder cancer using data from the SEER.Methods The data of patients diagnosed as N0 gallbladder cancer between 2004 and 2015 were extracted from the SEER database.Patients were divided into lymph node resection(LNR)group and non-LNR group using the R programming language.The primary outcome was cancer specific survival(CSS).Propensity score matching(PSM)was performed to ensure that the baseline characteristic of the two groups were comparable.The independent risk factors for CSS were identified with the application of LASSO method,univariable and multivariable Cox regression,and then the nomogram was constructed.The Kaplan-Meier method was employed to generate the survival curve,and the difference was compared by the log-rank test.Concordance index(C-index),receiver operating characteristic(ROC)curve and calibration curve were used to estimate the predicting accuracy of the model.Integrated discrimination improvement(IDI)was performed for risk discrimination.Results After PSM,a total of 2272 cases were enrolled.Age,grade,AJCC staging system,T stage and LNR were screened as independent risk factors for CSS of patients with N0 gallbladder cancer.The predicting accuracy of nomogram was good(C-index=0.738,standard error=0.007).The IDI of nomogram predicting 1-,3-and 5-year CSS were 0.084,0.111 and 0.115,which indicated the predicting improvement of nomogram compared with the AJCC stage.The clinical score for patients was obtained using our nomogram,and then patients were divided into high-and low-risk groups according to the median clinical score.Statistically significant difference was indicated between groups utilizing log-rank test,which demonstrated that our nomogram needed more clinical practice.Conclusion Lymph node dissection could significantly improve the prognosis of patients with N0 gallbladder cancer.The nomogram has a good capability in predicting CSS and risk stratification,which may promote the implementation of personalized and effective management.