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目的:比较经新辅助化疗后效果未达客观缓解的结直肠癌肝转移患者后续治疗选择直接手术或二线化疗后再手术的效果。方法:采用回顾性病例队列研究。回顾性收集2008年12月至2016年12月于中国医学科学院肿瘤医院肝胆外科行新辅助化疗未达客观缓解的107例结直肠癌肝转移患者的临床和病理学资料。男性 71例,女性36 例;中位年龄 57 岁(范围:28~79岁)。按新辅助化疗后的治疗方案不同,将患者分为直接手术组(直接组,n n=65)和接受二线化疗后手术组(二线组,n n=42)。采用 Logistic 回归模型的倾向性评分匹配(PSM)对两组患者肝转移灶的双肝叶分布和一线化疗周期数两个因素进行匹配,卡钳值设为 0.10,配比度为 1∶2。采用n t检验,Mann-Whitney n U检验、χn 2检验或Fisher确切概率法对两组数据进行统计分析。采用生存分析探讨两组患者的预后差异。n 结果:107例患者的随访时间为56.3(34.3)个月(范围:2.1~95.0个月),所有患者均获得随访。通过PSM后,直接组28例,二线组42例;两组术中是否可行R0切除、出血量、是否输血、术后并发症数量及术后住院时间的差异均无统计学意义(n P值均>0.05)。直接组1、3、5年无进展生存(PFS)率分别为40.0%、16.5%、11.0%,1、3、5年总体生存(OS)率分别为98.5%、61.2%、41.4%;二线组1、3、5年PFS率分别为35.7%、14.3%、14.3%,1、3、5年OS率分别为95.2%、55.1%、44.4%。直接组和二线组中位PFS时间分别为8.5个月和7.5个月,差异无统计学意义(n P=0.826);直接组和二线组的中位OS时间分别为33.8个月和46.9个月,差异无统计学意义(n P=0.646)。直接组和二线化疗完全缓解及部分缓解患者组(CR/PR组)患者的中位PFS时间分别为10.2个月和9.1个月,差异无统计学意义(n P=0.669);直接组和CR/PR组患者的中位OS时间分别为51.0个月和46.9个月,差异无统计学意义(n P=0.427)。生存分析结果提示,大范围肝切除是PFS和OS的独立预后因素(n HR=1.809,95%n CI:1.067~3.067,n P=0.028;n HR=2.751,95%n CI:1.317~5.747,n P=0.007);二线化疗不是PFS和OS独立预后因素(n HR=0.945,95%n CI:0.570~1.567,n P=0.828;n HR=0.866,95%n CI:0.468~1.602,n P=0.646)。n 结论:直接手术患者与接受二线化疗后手术患者在术后近期结局及远期预后方面无明显差异;二线化疗不是新辅助化疗后效果未达客观缓解的结直肠癌肝转移患者的独立预后因素。“,”Objective:To compare the effect of direct surgery or surgery after second-line chemotherapy for colorectal cancer patients with liver metastases who did not achieve objective remission after neoadjuvant chemotherapy.Methods:A retrospective case cohort study was used. The clinical and pathological data of 107 patients with colorectal cancer liver metastases who did not achieve objective response to neoadjuvant chemotherapy at Department of Hepatobiliary Surgery,Cancer Hospital,Chinese Academy of Medical Sciences from December 2008 to December 2016 were retrospectively collected. There were 71 males and 36 females, median age was 57 years (range: 28 to 79 years). According to the different treatment regimens after neoadjuvant chemotherapy,107 cases were divided into a direct surgery group (direct group,n n=65) and an operation after receiving second-line chemotherapy group (second-line group,n n=42). The propensity score matching(PSM) of the Logistic regression model was used to match the bilobar distribution of liver metastases and the number of first-line chemotherapy cycles in the two groups of patients. The caliper value was set to 0.10 and the matching ratio was 1∶2. n T test, Mann-Whitney n U test, χn 2 test or Fisher\'s exat test was used to analyzed the data between the tuo groups, respectively. Survival analysis design was used to investigate the difference in prognosis between the two groups of patients.n Results:The follow-up time(n M(IQR)) was 56.3(34.3) months (range: 2.1 to 95.0 months),and all patients were followed up. After PSM,there were 28 cases in the direct group and 42 cases in the second-line group, there were no significant differences in whether R0 resection was feasible,blood loss,blood transfusion,postoperative complications and postoperative hospital stay between the two groups (all n P>0.05). The 1,3,and 5-year progression-free survival(PFS) rates of the direct group were 40.0%,16.5%,and 11.0%,and the 1,3,and 5-year overall survival(OS) rates were 98.5%,61.2%,and 41.4%,respectively, the second-line group 1,3,5 years PFS rates were 35.7%,14.3%,14.3%,1,3,5-year OS rate were 95.2%,55.1%,44.4%,respectively. The median PFS time of the direct group and the second-line group was 8.5 months and 7.5 months,respectively,and the difference was not statistically significant (n P=0.826). The median OS time of the direct group and the second-line group were 33.8 months and 46.9 months,respectively. The difference was not statistically significant(n P=0.646).The median PFS time of the direct group and second-line chemotherapy complete remission and partial remission group(CR/PR group) was 10.2 months and 9.1 months,respectively,and the difference was not statistically significant(n P=0.669). The median OS time of the direct group and the second-line CR/PR group was 51.0 months and 46.9 months,respectively,and the difference was not statistically significant(n P=0.427). The results of survival analysis suggested that major liver resection was an independent prognosis factor for PFS (n HR=1.809,95%n CI: 1.067 to 3.067,n P=0.028) and OS(n HR=2.751,95%n CI: 1.317 to 5.747,n P=0.007). Second-line chemotherapy was not an independent prognostic factor for PFS(n HR=0.945,95%n CI:0.570 to 1.567,n P=0.828) and OS(n HR=0.866,95%n CI: 0.468 to 1.602,n P=0.646).n Conclusions:There is no significant difference in the short-term outcome and long-term prognosis between direct surgery patients and second-line chemotherapy followed by surgery. Second-line chemotherapy is not an independent prognostic factor for colorectal cancer liver metastases patients who fail to achieve objective response after neoadjuvant chemotherapy.