自膨式金属支架置入联合新辅助治疗应用于梗阻性结直肠癌的临床价值

Clinical value of self‑expandable metal stents implantation combined with neoadjuvant therapy in the treatment of obstructive colorectal cancer

  • 摘要:
    目的 探讨自膨式金属支架(SEMS)置入联合新辅助治疗(NAT)应用于梗阻性结直肠癌的临床价值。
    方法 采用回顾性队列研究方法。收集2011年1月至2025年12月我国两家医学中心收治的130例(空军军医大学唐都医院59例、首都医科大学附属北京朝阳医院71例)梗阻性结直肠癌患者的临床病理资料;男82例,女48例;年龄为62(26,75)岁。130例患者按治疗方法分为2组,其中84例行SEMS置入联合NAT桥接根治性手术的患者设为联合组,46例行SEMS置入桥接根治性手术的患者设为支架组。130例患者按收治时间分为2011年1月至2020年12月收治的队列1(62例)和2021年1月至2025年12月收治的队列2(68例)进行分析。观察指标:(1)不同队列中联合组和支架组患者一般资料比较。(2)不同队列中联合组患者NAT情况。(3)不同队列中患者支架置入相关并发症情况。(4)不同队列中患者围手术期情况。(5)不同队列中患者生存情况。正态分布的计量资料组间比较采用独立样本t检验。偏态分布的计量资料组间比较采用Mann⁃Whitney U检验。计数资料组间比较采用χ2检验、校正χ2检验或Fisher确切概率法。等级资料组间比较采用Mann⁃Whitney U检验。采用Kaplan‑Meier法计算生存时间并绘制生存曲线,采用Log‑rank检验进行生存分析。
    结果 (1)不同队列中联合组和支架组患者一般资料比较:队列1中,33例联合组和29例支架组患者术前血红蛋白分别为(104±19)g/L和(118±17)g/L,两组比较,差异有统计学意义(t=3.07,P<0.05)。队列2中,51例联合组和17例支架组患者一般资料比较,差异均无统计学意义(P>0.05)。(2)不同队列中联合组患者NAT情况:队列1中,33例联合组患者NAT均行化疗,疗程为2(1,4)个周期。队列2中,51例联合组患者NAT行化疗38例、化疗联合靶向治疗6例、化疗联合免疫治疗7例,NAT疗程为3(1,6)个周期。(3)不同队列中患者支架置入相关并发症情况:队列1中,33例联合组患者发生穿孔1例、再次肠梗阻2例、支架脱落0例;29例支架组患者上述指标分别为0、1、0例;两组患者支架置入相关并发症比较,差异无统计学意义(P>0.05)。队列2中,51例联合组患者发生穿孔1例、再次肠梗阻3例、支架脱落1例;17例支架组患者上述指标分别为1、0、0例;两组患者支架置入相关并发症比较,差异无统计学意义(P>0.05)。(4)不同队列中患者围手术期情况:队列1中,联合组患者NAT后肿瘤T降期1例,肿瘤N降期6例,肿瘤退缩分级(TRG)0~1级5例、2~3级11例;联合组和支架组患者支架置入至行根治性手术间隔时间、术后并发症比较,差异均有统计学意义(Z=-5.72,χ2=6.01,P<0.05)。队列2中,联合组患者NAT后肿瘤T降期14例,肿瘤N降期23例,TRG 0~1级10例、2~3级37例;联合组和支架组患者支架置入至行根治性手术间隔时间、手术时间、肿瘤病理学N分期比较,差异均有统计学意义(Z=-6.11、-2.22、-2.02,P<0.05)。(5)不同队列中患者生存情况:队列1中,联合组32例患者完成随访,随访时间为62(4,133)个月,1、3、5年无病生存率和总生存率分别为97.0%、80.3%、73.0%和93.9%、84.8%、66.0%;支架组25例患者完成随访,随访时间为81(11,158)个月,1、3、5年无病生存率和总生存率分别为96.6%、75.1%、57.2%和96.6%、79.3%、62.1%;两组患者无病生存和总生存情况比较,差异均无统计学意义(χ2=1.42,0.19,P>0.05)。队列2中,51例联合组患者均完成随访,随访时间为41(1,66)个月,1、3年无病生存率和总生存率分别为93.7%、76.9%和100.0%、94.3%;17例支架组患者均完成随访,随访时间为31(6,50)个月,1、3年无病生存率和总生存率分别为94.1%、52.4%和93.8%、60.8%;两组患者总生存情况比较,差异有统计学意义(χ2=8.48,P<0.05),无病生存情况比较,差异无统计学意义(χ2=1.62,P>0.05)。
    结论 与SEMS置入桥接根治性手术比较,SEMS置入联合NAT桥接根治性手术不增加梗阻性结直肠癌支架置入相关并发症的发生风险,且术后并发症发生比例更低,可提升患者总生存获益。

     

    Abstract:
    Objective To investigate the clinical value of self‑expandable metal stents (SEMS) implantation combined with neoadjuvant therapy (NAT) in the treatment of obstructive colorectal cancer.
    Methods The retrospective cohort study was conducted. The clinicopathological data of 130 patients with obstructive colorectal cancer who were admitted to two medical centers, including 59 cases from Tangdu Hospital of Air Force Medical University and 71 cases from Affiliated Beijing Chaoyang Hospital of Capital Medical University, from January 2011 to December 2025 were collected. There were 82 males and 48 females, aged 62(26,75) years. All 130 patients were divided into two groups based on treatment methods. The group of 84 patients who underwent SEMS implantation combined with NAT bridging radical surgery was designated as the combined group, while the group of 46 patients who underwent SEMS implantation bridging radical surgery was designated as the stent group. The 130 patients were further divided into two cohorts for analysis, including cohort 1 of 62 patients who were admitted from January 2011 to December 2020, and cohort 2 of 68 patients who were admitted from January 2021 to December 2025, respectively. Observation indicators: (1) comparison of general data between patients in the combined group and stent group in different cohorts; (2) NAT status of patients in the combined group of different cohorts; (3) complications related to stent implantation in patients in different cohorts; (4) perioperative conditions of patients in different cohorts; (5) survival status of patients in different cohorts. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Comparison of measurement data with skewed distribution between groups was conducted using the Mann‑Whitney U test. Comparison of count data between groups was conducted using the chi‑square test, corrected chi‑square test or Fisher exact probability. Comparison of ordinal data between groups was conducted using the Mann-Whitney U test. The Kaplan‑Meier method was used to calculate survival time and draw survival curves, and Log‑rank test was used for survival analysis.
    Results (1) Comparison of general data between patients in the combined group and stent group in different cohorts: in cohort 1, the number of patients in the combined group and stent group was 33 and 29, respectively, and the preoperative hemoglobin levels was (104±19) g/L and (118±17) g/L, respectively, showing a significant difference between the two groups (t=3.07, P<0.05). In cohort 2, the number of patients in the combined group and stent group was 51 and 17, respectively, and there was no significant difference in general data between the two groups (P>0.05). (2) NAT status of patients in the combined group of different cohorts: in cohort 1, all 33 patients in the combined group received NAT as chemotherapy, with a course of 2(1,4) cycles. In cohort 2, 51 patients in the combined group received NAT, including 38 cases of chemotherapy, 6 cases of chemotherapy combined with targeted therapy and 7 cases of chemotherapy combined with immunotherapy, with the NAT course of 3(1,6) cycles. (3) Complications related to stent implantation in patients in different cohorts: in cohort 1, among the 33 patients in the combined group, there was 1 case of perforation, 2 cases of re-intestinal obstruction, and 0 case of stent detachment. Among the 29 patients in the stent group, the above indicators were 0, 1, and 0 case, respectively. There was no significant difference in complications related to stent implantation in patients between the two groups (P>0.05). In cohort 2, among the 51 patients in the combined group, there was 1 case of perforation, 3 cases of re‑intestinal obstruction, and 1 case of stent detachment. Among the 17 patients in the stent group, the above indicators were 1, 0, and 0 case, respectively. There was no significant difference in complications related to stent implantation in patients between the two groups (P>0.05). (4) Perioperative conditions of patients in different cohorts: in cohort 1, among the patients who underwent NAT in the combined group, there was 1 case evaluated as tumor T downstaging, 6 cases evaluated as tumor N downstaging, 5 cases evaluated as 0-1 grading of tumor regression grade (TRG), and 11 cases evaluated as 2-3 grading of TRG. There were significant differences in interval time from stent implantation to radical surgery and postoperative complications in patients between the combined group and stent group (Z=-5.72, χ2=6.01, P<0.05). In cohort 2, among the patients who underwent NAT in the combined group, there was 14 cases evaluated as tumor T downstaging, 23 cases evaluated as tumor N down-staging, 10 cases evaluated as 0-1 grading of TRG, and 37 cases evaluated as 2-3 grading of TRG. There were significant differences in interval time from stent implantation to radical surgery, operation time and tumor pathological N staging in patients between the combined group and stent group (Z=-6.11, -2.22, -2.02, P<0.05). (5) Survival status of patients in different cohorts: in cohort 1, 32 patients in the combined group completed follow‑up, with a follow‑up time of 62(4,133) months, and the 1‑year, 3‑year, and 5‑year disease‑free survival rates and 1‑year, 3‑year, and 5‑year overall survival rates were 97.0%, 80.3%, 73.0%, and 93.9%, 84.8%, 66.0%, respectively. Twenty‑five patients in the stent group completed follow‑up, with a follow‑up time of 81(11,158) months, and the 1‑year, 3‑year, and 5‑year disease‑free survival rates and 1‑year, 3‑year, and 5‑year overall survival rates were 96.6%, 75.1%, 57.2%, and 96.6%, 79.3%, 62.1%, respectively. There was no significant difference in disease‑free survival and overall survival in patients between the two groups (χ2=1.42, 0.19, P>0.05). In cohort 2, all 51 patients in the combined group completed follow‑up, with a follow‑up time of 41(1,66) months, and the 1‑year, 3‑year disease‑free survival rates and 1‑year, 3‑year overall survival rates were 93.7%, 76.9% and 100.0%, 94.3%, respectively. All 17 patients in the stent group completed follow‑up, with a follow‑up time of 31(6,50) months, and the 1‑year, 3‑year disease‑free survival rates and 1‑year, 3‑year overall survival rates were 94.1%, 52.4% and 93.8%, 60.8%, respec-tively. There was a significant difference in overall survival in patients between the two groups (χ2=8.48, P<0.05), and there was no significant difference in disease-free free survival (χ2=1.62, P>0.05).
    Conclusion Compared to SEMS implantation bridging radical surgery, the combination of SEMS implantation and NAT bridging radical surgery does not increase the risk of complications related to stent implantation in obstructive colorectal cancer with low ratio of postoperative complication, and is expected to improve patient overall survival benefits.

     

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