【摘要】 目的比较真实世界研究条件下中国ⅠA1(LVSI+)～ⅠB1期子宫颈癌患者腹腔镜与开腹手术长期肿瘤学结局。方法基于中国子宫颈癌临床诊疗大数据库,纳入ⅠA1(LVSI+)～ⅠB1期子宫颈癌腹腔镜与开腹手术病例,在真实世界及1∶1倾向性评分匹配(PSM)条件下比较两种手术途径的5年总体生存率(OS)及无病生存率(DFS)。结果 (1)从数据库中纳入2009年1月1日至2016年12月31日的全部ⅠA1(LVSI+)～ⅠB1期子宫颈癌腹腔镜或开腹手术病例8490例,其中腹腔镜组3247例,开腹组5243例。匹配前两组5年OS无差异,但腹腔镜组5年DFS低于开腹组(88.3%vs. 90.5%,P=0.008),Cox多因素分析提示腹腔镜手术是患者复发/死亡的独立危险因素[HR(危险比)=1.329,95%CI 1.129～1.564,P=0.001]。经1∶1 PSM匹配后两组各纳入3077例,两组5年OS无差异,腹腔镜组5年DFS低于开腹组(87.9%vs. 90.6%,P=0.015),Cox多因素分析提示腹腔镜手术是患者复发/死亡的独立风险因素(HR=1.277,95%CI 1.062～1.535,P=0.009)。(2)进一步纳入术式为QM-B型或QM-C型子宫切除术的病例,共7952例(腹腔镜组3115例,开腹组4837例)。匹配前两组5年OS无差异,但腹腔镜组5年DFS低于开腹组(87.9%vs. 90.3%,P=0.013),Cox多因素分析提示腹腔镜手术是患者复发/死亡的独立危险因素(HR=1.326,95%CI 1.123～1.567,P=0.001)。1∶1 PSM匹配后两组各纳入2957例,两组5年OS无差异,但腹腔镜组5年DFS低于开腹组(88.4%vs. 90.7%,P=0.033),Cox多因素分析提示腹腔镜手术是患者复发/死亡的独立危险因素(HR=1.267,95%CI 1.048～1.532,P=0.015)。结论在真实世界研究下,经多层次分析显示,对于中国ⅠA1(LVSI+)～ⅠB1期子宫颈癌患者,腹腔镜手术5年无病生存率低于开腹手术,腹腔镜手术与更高的复发/死亡风险相关。更多还原

【Abstract】 Objective To compare the long-term oncological outcomes between laparoscopic and abdominal surgery in Chinese patients with stage Ⅰ A1(LVSI+)-Ⅰ B1 cervical cancer based on real world evidence.Methods Based on the Big Database of Clinical Diagnosis and Treatment of Cervical Cancer in China,patients with stage Ⅰ A1(LVSI+)-Ⅰ B1 cervical cancer who were treated by laparoscopic or abdominal surgery were included.The 5-year overall survival(OS) and disease-free survival(DFS) between the two surgical approaches were compared in real world condition and 1-1 propensity score matching(PSM).Results(1) A total of 8490 patients with stage Ⅰ A1(LVSI+)-Ⅰ B1 cervical cancer treated by laparoscopic or abdominal surgery from 2009-01-01 to 2016-12-31 were included.Among them,3247 were in the laparoscopic group and 5243 in the abdominal group.There was no difference in OS between the two groups before matching,but lower 5-year DFS was observed in the laparoscopic group compared to the abdominal group(88.3% vs.90.5%,P=0.008).Cox multivariate analysis suggested that laparoscopic surgery was an independent risk factor for recurrence/death(HR=1.329,95% C11.129-1.564,P=0.001).After 1:1 PSM matching,3077 patients were included in each group,and there was no difference in 5-year OS between the two groups.Lower 5-year DFS was observed in the laparoscopic group(87.9% vs.90.6%,P=0.015).Cox multivariate analysis showed that the laparoscopic surgery was an independent risk factor for recurrence/death(HR=1.277,95% CI 1.062-1.535,P=0.009).(2) A total of 7952 patients with QM-B or QM-C hysterectomy were further included,with 3115 patients in the laparoscopic group and 4837 patients in the abdominal group.There was no difference in OS between the two groups at 5 years before matching.But DFS in the laparoscopic group was lower than that in the abdominal group(87.9% vs.90.3%,P=0.013).Cox multivariate analysis also suggested that laparoscopic surgery was an independent risk factor for recurrence/death(HR=1.326,95%CI 1.123-1.567,P=0.001).After 1:1 PSM matching,2957 patients were included in each group,and there was no difference in 5-year OS between the two groups.The 5-year DFS in the laparoscopic group was lower than that in the abdominal group(88.4% vs.90.7%,P=0.033).Cox multivariate analysis suggested that laparoscopic surgery was an independent risk factor for recurrence/death(HR=1.267,95% CI 1.048-1.532,P=0.015).Conclusion In real world study,the multi-level analysis shows that for Chinese patients with stageⅠ A1(LVSI+)-Ⅰ B1 cervical cancer,the 5-year DFS of laparoscopic surgery is lower than that of abdominal surgery,and laparoscopic surgery is associated with a higher risk of recurrence/death.更多还原