ⅡA1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 oncoligical outcomes of laparoscopic and abdominal radical surgery for stageⅡA1 cervical cancer:a real world study

目的探讨真实世界研究条件下,中国ⅡA1期子宫颈癌腹腔镜与开腹手术长期肿瘤学结局的差异。方法回顾性分析2009—2016年中国部分地区ⅡA1期子宫颈癌3273例,通过真实世界研究和倾向评分匹配(PSM)的方法,对比腹腔镜与开腹手术5年总体生存率(OS)和5年无病生存率(DFS)的差异。结果(1)初始入组条件下的真实世界数据中,ⅡA1期子宫颈癌共3273例,腹腔镜组911例,开腹组2362例,匹配前,腹腔镜组的5年OS与开腹组差异无统计学意义(84.2%vs.87.1%,P=0.303),但5年DFS低于开腹组(78.6%vs.82.9%,P=0.014);Cox分析显示,腹腔镜手术不是患者死亡及复发/死亡的独立危险因素(OS:P=0.433;DFS:P=0.054)。1∶2 PSM匹配后,腹腔镜组891例,开腹组1650例,腹腔镜组的5年OS和DFS均与开腹组差异无统计学意义(OS:84.2%vs.86.7%,P=0.569;DFS:78.8%vs.82.0%,P=0.090);Cox分析显示,腹腔镜手术不是患者死亡及复发/死亡的独立危险因素(OS:P=0.668;DFS:P=0.172)。(2)进一步限定行QM-B型或QM-C型子宫切除术的ⅡA1期子宫颈癌患者共3020例,腹腔镜组888例,开腹组2132例,匹配前,腹腔镜组的5年OS与开腹组差异无统计学意义(84.0%vs.87.8%,P=0.198),但5年DFS低于开腹组(78.6%vs.83.5%,P=0.010);Cox分析显示,腹腔镜手术是患者复发/死亡的独立危险因素(HR=1.263,95%CI 1.019~1.566,P=0.033)。1∶2 PSM匹配后,腹腔镜组843例,开腹组1510例,腹腔镜组的5年OS与开腹组差异无统计学意义(83.9%vs.88.1%,P=0.083),但腹腔镜组5年DFS低于开腹组(79.0%vs.83.6%,P=0.019),腹腔镜手术是患者复发/死亡的独立危险因素(HR=1.295,95%CI 1.025~1.636,P=0.030)。结论在真实世界研究中,ⅡA1期子宫颈癌腹腔镜手术长期肿瘤学结局与开腹手术未见差异;但在规范术式条件下,行腹腔镜手术的患者复发风险更高。

Objective To determine the long-term oncological outcomes of laparoscopic(LRH)and abdominal radical surgery(ARH)for cervical cancer patients with stageⅡA1 in China under real world study.Methods We retrospectively analyzed the clinical data of 3273 patients with stageⅡA1 cervical cancer in China from 2009 to 2016.By the method of real world study and propensity score matching(PSM),the 5-year overall survival(OS)and disease-free survival(DFS)were compared between LRH group and ARH group.Results In the real world data of initial criteria,a total of 3273cervical cancer patients(LRH 911 vs.ARH 2362)were included.Before matching,no significant difference was found between two groups in 5-year OS(84.2%vs.87.1%,P=0.303).However,LRH had a lower 5-year DFS than ARH(78.6%vs.82.9%,P=0.014).Cox analyses showed that LRH was not an independent risk factor for death or recurrence/death(OS:P=0.433;DFS:P=0.054).After 1:2 PSM matching,LRH group had 891 patients and ARH group had 1650 patients.No significant difference was found between two groups in 5-year OS or DFS(OS:84.2%vs.86.7%,P=0.569;DFS:78.8%vs.82.0%,P=0.090).Cox analyses showed that LRH was not an independent risk factor for death or recurrence/death(OS:P=0.668;DFS:P=0.172).After additional inclusion criteria of QM-B or C radical surgery,a total of 3020 patients with stageⅡA1 cervical cancer(LRH 888 vs.ARH 2132)were included.Before matching,no significant difference was found between two groups in 5-year OS(84.0%vs.87.8%,P=0.198).However,LRH had a lower 5-year DFS than ARH(78.6%vs.83.5%,P=0.010).Cox analyses showed that LRH was an independent risk factor for recurrence/death(HR:1.263;95%CI,1.019-1.566,P=0.033).After 1:2 PSM matching,LRH group had 843 patients and ARH group had 1510 patients.No significant difference was found between two groups in 5-year OS(83.9%vs.88.1%,P=0.083).However,LRH had a lower 5-year DFS than ARH(79.0%vs.83.6%,P=0.019).Cox analyses showed that LRH was an independent risk factor for recurrence/death(HR:1.295;95%CI,1.025-1.636;P=0.030).Conclusion In the real world clinical study,LRH has similar long-term oncological outcomes with ARH in patients with stageⅡA1 cervical cancer in China.However,under standardized surgery,LRH has a higher risk of recurrence than ARH.