Objective: To compare the long-term oncological outcomes between laparoscopic and abdominal surgery in stage Ⅰa1 （lymph-vascular space invasion-positive, LVSI+）- Ⅰb1 cervical cancer patients with different tumor sizes. Methods: Based on the Big Database of Clinical Diagnosis and Treatment of Cervical Cancer in China (1538 project database), patients with stage Ⅰa1 （LVSI+）-Ⅰb1 cervical cancer who treated by laparoscopic or abdominal surgery were included. The 5-year overall survival (OS) and 5-year disease-free survival (DFS) between the two surgical approaches were compared under 1∶1 propensity score matching (PSM) in different tumor diameter stratification. Results: (1) A total of 4 891 patients with stage Ⅰa1 （LVSI+）-Ⅰb1 cervical cancer who underwent laparoscopy or laparotomy from January 1, 2009 to December 31, 2016 were included in the 1538 project database. Among them, 1 926 cases in the laparoscopic group and 2 965 cases in the abdominal group. There were no difference in 5-year OS and 5-year DFS between the two groups before matching. Cox multivariate analysis suggested that laparoscopic surgery was associated with lower 5-year DFS (HR=1.367, 95%CI: 1.105-1.690, P=0.004). After 1∶1 PSM matching, 1 864 patients were included in each group, and there was no difference in 5-year OS between the two groups （94.1% vs 95.4%, P=0.151）. While, the inferior 5-year DFS was observed in the laparoscopic group (89.0% vs 92.3%, P=0.004). And the laparoscopic surgery was associated with lower 5-year DFS (HR=1.420, 95%CI: 1.109-1.818, P=0.006). (2) In stratification analysis of different tumor sizes, and there were no difference in 5-year OS and 5-year DFS between the laparoscopic group and abdominal group in tumor size ≤1 cm, >1-2 cm and >2-3 cm stratification (all P>0.05). Cox multivariate analysis showed that laparoscopic surgery were not related to 5-year OS and 5-year DFS (P>0.05). In the stratification of tumor size >3-4 cm, there was no difference in 5-year OS between the two groups (P>0.05). The 5-year DFS in the laparoscopic group was worse than that in the abdominal group (75.7% vs 85.8%, P=0.025). Cox multivariate analysis suggested that laparoscopic surgery was associated with lower 5-year DFS (HR=1.705, 95%CI: 1.088-2.674, P=0.020). Conclusions: For patients with stage Ⅰa1 （LVSI+）-Ⅰb1 cervical cancer, laparoscopic surgery is associated with lower 5-year DFS, and the adverse effect of laparoscopic surgery on oncology prognosis is mainly reflected in patients with tumor size >3-4 cm. For patients with tumor sizes ≤1 cm, >1-2 cm and >2-3 cm, there are no difference in oncological prognosis between the two surgical approaches.
目的： 比较不同肿瘤直径的Ⅰa1［淋巴脉管间隙浸润（LVSI）阳性］~Ⅰb1期［按照国际妇产科联盟（FIGO 2009）的分期标准］子宫颈癌患者腹腔镜手术与开腹手术的长期肿瘤学结局的差异。 方法： （1）基于中国子宫颈癌临床诊疗大数据项目，纳入2009年1月1日—2016年12月31日符合入组条件的Ⅰa1（LVSI阳性）~Ⅰb1期子宫颈癌患者行腹腔镜手术（腹腔镜组）与开腹手术（开腹组）的患者，进行1∶1倾向性评分匹配（PSM）方法匹配，比较匹配前、后两组患者的肿瘤学结局。（2）将纳入的Ⅰa1（LVSI阳性）~Ⅰb1期子宫颈癌手术患者，进一步根据肿瘤直径的不同分为4层，即肿瘤直径≤1 cm、>1~2 cm、>2~3 cm、>3~4 cm，并在每个分层中分别对腹腔镜与开腹组进行1∶1 PSM方法匹配，比较不同肿瘤直径的两组患者的肿瘤学结局。肿瘤学结局的评价指标为5年总生存率（OS）及5年无瘤生存率（DFS）。 结果： （1）本研究纳入Ⅰa1（LVSI阳性）~Ⅰb1期子宫颈癌腹腔镜、开腹手术患者共4 891例，其中腹腔镜组1 926例，开腹组2 965例。PSM方法匹配前，腹腔镜组、开腹组患者的5年OS分别为94.1%、94.0%，5年DFS分别为89.1%、90.7%，两组分别比较，差异均无统计学意义（P=0.971，P=0.165）；多因素分析（Cox风险比例回归模型）显示，腹腔镜手术是影响子宫颈癌患者5年DFS的独立危险因素（HR=1.367，95%CI为1.105~1.690，P=0.004）。经1∶1 PSM方法匹配后，腹腔镜组、开腹组各纳入1 864例，两组患者的5年OS（分别为94.1%、95.4%）比较无显著差异（P=0.151），但腹腔镜组的5年DFS显著低于开腹组（分别为89.0%、92.3%，P=0.004）；多因素分析显示，腹腔镜手术是影响子宫颈癌患者5年DFS的独立危险因素（HR=1.420，95%CI为1.109~1.818，P=0.006）。（2）在不同肿瘤直径的分层分析中，腹腔镜组与开腹组的5年OS及5年DFS在肿瘤直径≤1 cm、>1~2 cm、>2~3 cm的3个分层中均无显著差异（P>0.05）；多因素分析显示，手术途径不是影响子宫颈癌患者5年OS和5年DFS的独立危险因素（P>0.05）。而在肿瘤直径>3~4 cm的分层中，腹腔镜组与开腹组的5年OS比较无显著差异（P=0.284），但腹腔镜组的5年DFS显著低于开腹组（75.7%、85.8%，P=0.025）；多因素分析显示，腹腔镜手术是影响子宫颈癌患者5年DFS的独立危险因素（HR=1.705，95%CI为1.088~2.674，P=0.020）。 结论： 对于Ⅰa1（LVSI阳性）~Ⅰb1期子宫颈癌患者，腹腔镜手术是影响患者5年DFS的独立危险因素。腹腔镜手术对子宫颈癌患者肿瘤学结局的不良影响主要体现于肿瘤直径>3~4 cm的患者中，而对于肿瘤直径≤1 cm、>1~2 cm、>2~3 cm的子宫颈癌患者，两种手术途径的肿瘤学结局无显著差异。.
Keywords: Laparoscopy; Laparotomy; Prognosis; Treatment outcome; Uterine cervical neoplasms.