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

Long-term oncological outcomes of laparoscopic vs. abdominal approach to FIGO stageⅠA1(LVSI+)-ⅡA1 cervical cancer in real world study

目的探讨真实世界研究(RWS)条件下ⅠA1(LVSI+)~ⅡA1期子宫颈癌腹腔镜开腹手术长期肿瘤学结局。方法从中国子宫颈癌临床诊疗大数据库中筛选接受腹腔镜和开腹手术的ⅠA1(LVSI+)~ⅡA1期子宫颈癌患者,采用RWS及倾向评分匹配(PSM1∶1)的方法,通过K-M生存分析和Cox多因素分析对两组患者的肿瘤学结局进行比较。结果 (1)经初步筛选纳入ⅠA1(LVSI+)~ⅡA1期子宫颈癌14 445例,其中腹腔镜组4977例,开腹组9468例;匹配前腹腔镜组与开腹组的5年总体生存率(OS)差异无统计学意义(OS 89.90%vs. 91.40%,P=0.388),但腹腔镜组5年无瘤生存率(DFS)低于开腹组(DFS:85.10%vs. 87.60%,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(HR=1.253,95%CI 1.078~1.455,P=0.003;HR=1.355,95%CI 1.213~1.514,P<0.001);1∶1匹配后两组分别纳入4959例,腹腔镜组5年OS、DFS均低于开腹组(OS:89.70%vs. 92.10%,P=0.030;DFS:84.90%vs. 88.40%,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(HR=1.300,95%CI 1.096~1.542,P=0.003;HR=1.373,95%CI 1.209~1.560,P<0.001)。(2)进一步限定行QM-B型或QM-C型子宫切除术的病例共13 431例,其中腹腔镜组4750例,开腹组8681例;匹配前两组的5年OS差异无统计学意义(OS 89.90%vs. 91.30%,P=0.370),但是腹腔镜组5年DFS低于开腹组(DFS:85.10%vs. 87.60%,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(HR=1.239,95%CI 1.062~1.445,P=0.006;HR=1.349,95%CI 1.204~1.512,P<0.001);1∶1匹配后腹腔镜组和开腹组分别纳入4732例,腹腔镜组5年OS、DFS均低于开腹组(OS:89.90%vs.92.30%,P=0.017;DFS:84.80%vs. 88.40%,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(HR=1.292,95%CI 1.084~1.539,P=0.004;HR=1.352,95%CI1.186~1.541,P<0.001)。结论 RWS条件下从手术途径方面进行多层次对比分析发现,ⅠA1(LVSI+)~ⅡA1期子宫颈癌腹腔镜组5年总体生存率和5年无瘤生存率均低于开腹组,腹腔镜手术是复发/死亡的独立危险因素。

Objective To compare the long-term onco-logical outcomes of laparoscopic radical hysterectomy(LRH)and abdominal radical hysterectomy(ARH)for FI-GO Stage ⅠA1(LVSI+)-ⅡA1 cervical cancer in Chinain real world study.MethodsBased on the Big Data-base of Clinical Diagnosis and Treatment of Cervical Can-cer in China,patients with stage ⅠA1(LVSI+)-ⅡA1 cervical cancer who were treated by laparoscopic or abdominal surgery were included.We compared the oncological out-comes of the two groups by using real world study,propensity score matching(PSM 1∶1),K-M survival analysis and Coxmultivariate analysis.Results(1)A total of 14 445 patients with stage ⅠA1(LVSI+)-ⅡA1 cervical cancer treated bylaparoscopic or abdominal surgery were included.Among them,4977 were in the LRH group and 9468 were in the ARHgroup. In the real world study,there was no significant difference in the 5-year OS between LRH group and ARH group(OS:89.90% vs. 91.40%,P=0.388),but the 5-year DFS in LRH group was lower than in ARH group(DFS:85.10% vs.87.60%,P<0.001),and LRH was an independent risk factor for death and relapse/death(HR=1.253,95% CI 1.078-1.455,P=0.003;HR=1.355,95% CI 1.213-1.514,P<0.001).After 1∶1 PSM matching,4959 cases were included inthe LRH group and the ARH group,respectively. The the 5-year OS and DFS in the LRH group were lower than those inthe ARH group(OS:89.70% vs. 92.10%,P=0.030;DFS:84.90% vs. 88.40%,P<0.001). LRH was the independentrisk factor for death and relapse/death(HR=1.300,95% CI 1.096-1.542,P=0.003;HR=1.373,95% CI 1.209-1.560,P<0.001).(2)A total of 13 431 patients with QM-B or QM-C hysterectomy were further included,with 4750 patientsin the LRH group and 8681 patients in the ARH group.There was no difference in the 5-year OS between the two groups(89.90% vs. 91.30%,P=0.370),but the 5-year DFS in LRH group was lower than that in ARH group(DFS:85.10% vs.87.60%,P=0.001),and LRH was an independent risk factor for death and relapse/death(HR=1.239,95% CI 1.062-1.445,P=0.006;HR=1.349,95% CI 1.204-1.512,P<0.001). After 1∶1 PSM matching,4732 cases were included inthe LRH group and the ARH group,respectively.The 5-year OS and DFS in LRH group were lower than those in ARHgroup(OS:89.90% vs. 92.30%,P=0.017;DFS:84.80% vs. 88.40%,P<0.001). LRH was an independent risk factorfor death and relapse/death(HR=1.292,95% CI 1.084-1.539,P=0.004;HR=1.352,95% CI 1.186-1.541,P<0.001).ConclusionUnder real-world study conditions,multi-level analysis from the perspective of surgical approachesshows that the 5-year OS and DFS were lower in LRH group than in ARH group of FIGO stage ⅠA1(LVSI+)-ⅡA1 cer-vical cancer.LRH is an independent risk factor for relapse/death.