肝外胆道恶性肿瘤根治术后替吉奥单药辅助化疗的临床研究

Clinical study of S-l single agent adjuvant chemotherapy in the radical resection of extrahepatic biliary carcinoma

目的探讨肝外胆道恶性肿瘤根治术后替吉奥单药辅助化疗的有效性。方法回顾性分析2014年1月至2017年6月郑州大学第一附属医院肝胆胰外科收治的108例肝外胆道恶性肿瘤并行根治性R0切除手术患者的临床资料。其中男性62例(57.4%)、女性46例(42.6%),中位年龄59岁(范围:26~79岁),Ⅱ期10例(9.3%)、Ⅲ期85例(78.7%)、Ⅳ期13例(12.0%),肝门部胆管癌40例(37.0%)、中段胆管癌8例(7.4%)、远端胆管癌25例(23.2%)、胆囊癌35例(32.4%)。根据术后是否接受化疗分为两组:化疗组49例,术后行替吉奥单药辅助化疗;非化疗组59例,术后未行化疗。随访并统计两组患者的总体生存时间,无瘤生存时间,1、2、3年总体生存率及化疗组的不良反应发生情况。采用Kaplan-Meier方法绘制累积生存曲线并进行Log-rank检验。结果两组患者的性别、年龄、病灶最大径、肿瘤部位、TNM分期、病理分级的差异均无统计学意义(P值均>0.05)。化疗组术后总体中位生存时间为27个月,无瘤中位生存时间为21个月;未化疗组术后总体中位生存时间为21个月,无瘤中位生存时间为17个月。两组患者总体生存时间比较,差异有统计学意义(χ^2=3.967,P<0.05);化疗组和未化疗组患者1年总体生存率(83.4%和79.7%)比较,差异无统计学意义(χ^2=0.286,P>0.05);2、3年总体生存率(63.3%、36.6%和41.6%、20.4%)比较,差异有统计学意义(χ^2=4.510,P<0.05;χ^2=6.143,P<0.05)。两组患者无瘤生存期比较,差异无统计学意义(χ^2=0.876,P>0.05);1、2、3年无瘤生存率(77.6%、41.4%、33.1%和62.7%、30.9%、21.2%)比较,差异均无统计学意义(χ^2=0.252,P>0.05;χ^2=1.571,P>0.05;χ^2=3.323,P>0.05)。化疗过程中主要不良反应为消化不良(28.6%,14/49)、贫血(26.5%,13/49)、白细胞计数减少(22.5%,11/49)等,均为轻度。结论肝外胆道恶性肿瘤行根治术后给予替吉奥单药辅助化疗,可有效改善患者生存预后,且不良反应程度较轻。

Objective To explore the clinical efficacy of S-1 single agent adjuvant chemotherapy for the patients undergoing radical resection of extrahepatic biliary carcinoma.Methods The clinical data of 108 patients with extrahepatic biliary carcinoma receiving radical resection who were admitted from January 2014 to June 2017 were retrospectively analyzed.There were 62 males(57.4%)and 46 females(42.6%),with a median age of 59 years(range:26 to 79 years),10 cases(9.3%)in stageⅡ,85 cases(78.7%)in stageⅢ,and 13 cases(12.0%)in stageⅣ,40 cases(37.0%)of hilar cholangiocarcinoma,8 cases(7.4%)of middle cholangiocarcinoma,25 cases(23.2%)of distal cholangiocarcinoma,35 cases(32.4%)of gallbladder carcinoma.After radical resection of extrahepatic biliary carcinoma,49 patients receiving S-1 single agent chemotherapy and 59 patients receiving non-special treatment were divided into the chemotherapy group and the operation group,respectively.All the dates of the patients were followed up and collected with the overall survival time,tumor-free survival time,1,2 and 3-year survival rate after operation,and the rate of major toxic reaction during chemotherapy of the chemotherapy group.Survival curve was drawn by the Kaplan-Meier method,and survival analysis was done using the Log-rank test.Results There were no significant differences in the general date of two groups(sex,age,tumor size,tumor site,TNM stages,degree of differentiation).The median overall survival time and the median tumor-free survival time in the chemotherapy group were 27 months and 21 months,respectively,and in the operation group were 21 months and 17 months,respectively.There were differences between the two groups in the overall survival rates(χ^2=3.967,P<0.05)and the 2 and 3-year survival rate(63.3%,36.6%;41.6%,20.4%;χ^2=4.510,P<0.05;χ^2=6.143,P<0.05),but the 1-year overall survival rate(83.4%,79.7%)was not statistically significant(χ^2=0.286,P>0.05).There were no significant differences in the tumor-free survival time,1,2 and 3-year tumor-free survival rate(77.6%,41.4%,33.1%;62.7%,30.9%,21.2%)between the two groups(χ^2=0.876,P>0.05;χ^2=0.252,P>0.05;χ^2=1.571,P>0.05;χ^2=3.323,P>0.05,respectively).The main toxic reaction during chemotherapy were dyspepsia(28.6%,14/49),anemia(26.5%,13/49),and leukopenia(22.5%,11/49),all of which were mild.Conclusion S-1 single agent chemotherapy after radical reseetion of extrahepatic biliary carcinoma could effectly improve the survival of patients and all of the main toxic reaction during chemotherapy were mild.