ⅠA1(LVSI+)~ⅠB2期子宫颈癌腹腔镜与开腹手术长期肿瘤学结局真实世界研究

Long-term oncological outcome of laparoscopic surgery and abdominal surgery for cervical cancer of stageⅠA1(LVSI+)toⅠB2:a real world study

目的探讨ⅠA1(LVSI+)~ⅠB2期子宫颈癌腹腔镜与开腹手术的长期肿瘤学结局。方法基于中国子宫颈癌临床诊疗大数据库,应用真实世界及1∶2倾向评分匹配的方法,比较匹配前后ⅠA1(LVSI+)~ⅠB2期子宫颈癌腹腔镜与开腹手术5年总体生存率(OS)及无病生存率(DFS)。结果(1)将10821例符合初始入组条件的ⅠA1(LVSI+)~ⅠB2期子宫颈癌病例分为腹腔镜组3950例、开腹组6871例,匹配前两组患者5年OS差异无统计学意义(90.7%vs.92.5%,P=0.325);但腹腔镜组5年DFS低于开腹组(86.1%vs.88.9%,P=0.001),Cox多因素分析提示,腹腔镜手术是患者死亡和复发/死亡的独立危险因素(OS:HR=1.215,95%CI 1.016~1.452,P=0.033;DFS:HR=1.132,95%CI 1.176~1.531,P<0.001)。因两组年龄、组织学类型、分期及术后病理中高危因素等存在差异,再行1∶2倾向评分匹配后发现,腹腔镜组(2341例)5年OS与开腹组(4682例)差异无统计学意义(89.9%vs.92.0%,P=0.267),但腹腔镜组5年DFS仍低于开腹组(84.7%vs.88.0%,P<0.001),且腹腔镜手术是影响患者复发/死亡的独立危险因素(HR=1.311,95%CI 1.119~1.535,P=0.001)。(2)限定QM-B型或QM-C型子宫切除术为进一步入组条件,入组腹腔镜组3792例、开腹组6370例,匹配前两组患者5年OS差异无统计学意义(91.0%vs.92.3%,P=0.501),但腹腔镜组5年DFS低于开腹组(85.9%vs.88.7%,P=0.003),Cox多因素分析提示,腹腔镜手术是子宫颈癌患者复发/死亡的独立危险因素(HR=1.328,95%CI 1.161~1.519,P<0.001)。行1∶2匹配后腹腔镜组(2117例)与开腹组(4234例)5年OS差异无统计学意义(90.2%vs.92.1%,P=0.224),但腹腔镜组5年DFS低于开腹组(83.3%vs.88.5%,P<0.001);Cox多因素分析提示,腹腔镜手术是子宫颈癌患者复发/死亡的独立危险因素(HR=1.407,95%CI 1.195~1.658,P<0.001)。结论在真实世界研究条件下,经分层分析,ⅠA1(LVSI+)~ⅠB2期子宫颈癌腹腔镜组5年OS与开腹组无差异,但5年DFS低于开腹组,且腹腔镜手术是影响患者死亡及复发/死亡的独立危险因素。

Objective To compare the long-term oncological outcomes of laparoscopic surgery(LS)with that of abdominal surgery(AS)for cervical cancer of stageⅠA1(LVSI+)toⅠB2.Methods Based on the big database of clinical diagnosis and treatment of cervical cancer in China,with the methods of real world study and 1∶2 propensity score matching(PSM),5-year overall survival(OS)and 5-year disease-free survival(DFS)were compared between laparoscopic surgery and abdominal surgery,before and after PSM.Results(1)A total of 10821 patients with cervical cancer of stageⅠA1(LVSI+)toⅠB2 who underwent laparoscopic surgery and abdominal surgery were initially included.Before PSM,there were no differences in 5-year OS between LS group(n=3950)and AS group(n=6871)(90.7%vs.92.5%,P=0.325),but the 5-year DFS of LS group was lower than AS group(86.1%vs.88.9%,P=0.001).Cox analysis suggested that LS was an independent risk factor for death and relapse/death(OS:HR=1.215,95%CI 1.016-1.452,P=0.033;DFS:HR=1.132,95%CI 1.176-1.531,P<0.001).Because there was difference in such risk factors as age,histologial type,staging and postoperative pathology before the two groups,PSM was again performed.There were no differences in 5-year OS between LS group(n=2341)and AS group(n=4682)(89.9%vs.92.0%,P=0.267),but the 5-year DFS of LS group was lower than AS group(84.7%vs.88.0%,P<0.001).Cox analysis suggested that LS was an independent risk factor for relapse/death(HR=1.311,95%CI 1.119-1.535,P=0.001).(2)A total of 10162 patients who underwent laparoscopic radical hysterectomy(LRH)or abdominal radical hysterectomy(ARH)in type B or type C were included.Before PSM,there were no differences in 5-year OS between LRH group(n=3792)and ARH group(n=6370)(91.0%vs.92.3%,P=0.501),but the 5-year DFS of LRH group was lower than ARH group(85.9%vs.88.7%,P=0.003).Cox analysis suggested that LRH was an independent risk factor for relapse/death(HR=1.328,95%CI 1.161-1.519,P<0.001).After PSM,6351 patients were included.There were no differences in 5-year OS between LRH group(n=2117)and ARH group(n=4234)(90.2%vs.92.1%,P=0.224),but the 5-year DFS of LRH group was lower than ARH group(83.3%vs.88.5%,P<0.001).Cox analysis suggested that LRH was an independent risk factor for relapse/death(HR=1.407,95%CI 1.195-1.658,P<0.001).Conclusion In the condition of real world study,are were no differences in 5-year OS between LRH and ARH for cervical cancer of stageⅠA1(LVSI+)toⅠB2,but the 5-year DFS of LRH is lower than ARH.LRH is an independent risk factor for death and relapse/death.