真实世界研究条件下中国子宫颈癌腹腔镜和开腹手术长期肿瘤学结局研究

Long-term oncological outcomes of laparoscopic vs.abdominal approach to cervical cancer in China in real world study

目的探讨真实世界研究条件下中国子宫颈癌腹腔镜和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数据库,采用真实世界研究及倾向评分匹配(1:1)的方法,分别分析不同入组条件下2009-2016年子宫颈癌腹腔镜手术(腹腔镜组)和开腹手术(开腹组)患者长期肿瘤学结局。结果(1)初始入组全部子宫颈癌腹腔镜和开腹手术的20 206例患者,平均年龄(48.31±9.39)岁,中位随访时间42个月(腹腔镜组vs.开腹组:30个月vs.48个月)。匹配前,腹腔镜组(n=6790)5年总体生存率(OS)和无瘤生存率(DFS)与开腹组(n=13 416)差异无统计学意义(OS:88.7%vs.89.6%,P=0.289;DFS:84.0%vs.85.1%,P=0.234),但Cox分析提示腹腔镜手术是患者复发/死亡的独立危险因素(HR=1.167,95%CI 1.069~1.276,P=0.001);匹配后两组各纳入6212例,腹腔镜组5年OS、DFS均低于开腹组(OS:89.4%vs.92.0%,P=0.013;DFS:84.7%vs.88.0%.P<0.001),腹腔镜手术是患者死亡及复发/死亡的独立危险因素(OS:HR=1.215,95%CI 1.045~1.412,P=0.011;DFS:HR=1.314,95%CI 1.174~1.470,P<0.001)。(2)进一步入组行腹腔镜或开腹QM-B/C型子宫切除术的17 580例患者,匹配前腹腔镜组(5940例)与开腹组(11 640例)5年OS差异无统计学意义(88.7%vs.89.6%,P=0.582),腹腔镜组5年DFS低于开腹组(83.3%vs.85.1%,P=0.030),腹腔镜手术是患者复发/死亡的独立危险因素(HR=1.197,95%CI 1.091~1.314,P<0.001);匹配后两组各纳入5674例,腹腔镜组5年OS、DFS均低于开腹组(OS:89.0%vs.91.1%,P=0.044:DFS:83.7%vs.87.0%,P<0.001),Cox分析提示腹腔镜手术是患者复发/死亡的独立危险因素(HR=1.297,95%CI 1.157~1.453,P <0.001)。结论在真实世界研究条件下多层次分析显示,接受腹腔镜手术治疗的子宫颈癌患者5年OS、DFS均低于开腹手术者,腹腔镜手术是子宫颈癌患者较低5年DFS的独立危险因素。

Objective To compare the long-term oncological outcomes of laparoscopic radical hysterectomy(LRH) and abdominal radical hysterectomy(ARH) for cervical cancer in China in real world study.Methods Based on the big database of clinical diagnosis and treatment for cervical cancer in China,long-term oncological outcomes of LRH and ARH were compared,using real world study and propensity score matching(PSM).Results(1) In total,20 206 patients who underwent either LRH or ARH were initially included,with an average age of(48.31±9.39) years and a median follow-up period of 42 months(LRH vs.ARH:30 vs.48).Before matching,there were no differences in 5-year OS or DFS between LRH group(n=6790)and ARH group(n=13 416) at 5 years(OS:88.7% vs.89.6%,P=0.289;DFS:84.0%vs.85.1%,P=0.234).Cox analysis suggested that LRH was an independent risk factor for relapse/death(HR=1.167,95%CI 1.069-1.276,P=0.001).After matching,6212 cases were included in each of the two groups.LRH was associated with a lower rate of 5-year OS and DFS than ARH(OS:89.4% vs.92.0%,P=0.013;DFS:84.7% vs.88.0%,P <0.001).LRH was an independent risk factor for death and relapse/death.(OS:HR=1.215,95% CI 1.045-1.412,P=0.011;DFS:HR=1.314,95%CI 1.174-1.470,P<0.001).(2) A total of 17 580 patients who underwent laparoscopic or abdominal type B or type C RH were included.Before matching,the 5-year OS was similar between the two groups(88.7 % vs.89.6%,P=0.582),whereas LRH(n=5940) was associated with a lower rate of 5-year DFS than ARH(n=1 1640)(83.3% vs.85.1%,P=0.030).LRH was an independent risk factor for relapse/death(HR=1.197,95% CI 1.091-1.314,P<0.001).After matching,5674 patients were included in each of the two groups.The 5-year OS and DFS of LRH were lower than ARH group(OS:89.0% vs.91.1%,P=0.044;DFS:83.7% vs.87.0%,P<0.001).Cox analysis suggested that LRH was an independent risk factor for relapse/death(HR=1.297,95% CI 1.157-1.453,P<0.001).Conclusion Under real world study conditions,multi-level analysis shows that laparoscopic radical hysterectomy is associated with lower overall survival and disease-free survival than abdominal radical hysterectomy among women with cervical cancer.Laparoscopic surgery is an independent risk factor of lower disease-free 5-year survival for cervical cancer patients.