Clinical Study Of S-1 Single Agent Adjuvant Chemotherapy In The Radical Resection Of Extrahepatic Biliary Carcinoma

BackgroundMost of biliary carcinoma originates from the bile duct epithelium.According to the anatomical site,it is divided into intrahepatic cholangiocarcinoma(ICC),extrahepatic cholangiocarcinoma(ECC),and gallbladder carcinoma(carcinoma of gallbladder),and more than 80% of pathological types are adenocarcinoma.Biliary carcinoma are often insidious,and early diagnosis is difficult.The proportion of patients who can achieve curative resection is less than 40%,and postoperative recurrence is easy.The prognosis is extremely poor.At present,surgical resection is still the only way to cure biliary carcinoma.The 5-year survival rate of patients undergoing R0 resection is increased to 20-50%.However,even if patients undergoing surgical R0 resection,the recurrence rate is as high as 50% or more,so biliary malignancy Treatment after radical tumor resection is essential for improving prognosis.Studies have shown that adjuvant chemotherapy after biliary malignancy can significantly improve the prognosis of patients.In 2010,Valle et al used gemcitabine combined with cisplatin as an adjuvant chemotherapy for unresectable biliary malignancies,but the prognosis of patients was not significantly improved.Previous phase II clinical trials and retrospective studies suggest that S-1 single-agent adjuvant chemotherapy may be one of the effective chemotherapy options for biliary malignancies.The effectiveness of adjuvant chemotherapy for biliary malignancies has been confirmed,but the specific protocol is still controversial.In view of the heterogeneity of clinical features and biological characteristics of ICC,whether adjuvant chemotherapy is effective after stage I biliary malignancy is not controversial,so it was not included in this study.ObjectiveThe clinical data of patients undergoing radical surgery for extrahepatic biliary malignancies in the hepatobiliary surgery of our hospital were retrospectively analyzed to further investigate the effectiveness of S-1 single-agent adjuvant chemotherapy.Materials and methodsThe 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(26-79 years),10 cases(9.3%)in stage II,85 cases(78.7%)in stage III,and 13 cases(12.0%)in stage ?,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 all patients were followed up and collected with the overall survival time,tumor-free survival time,the 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.ResultsThere 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(?~2=3.967,P <0.05)and the 2 and 3-year survival rate(?~2=4.510,P<0.05;?~2=6.143,P<0.05),but the 1-year overall survival rate was not statistically significant(?~2=0.286,P>0.05).There were no significant differences in the tumor-free survival time,the 1,2 and 3-year tumor-free survival rate between the two groups(?~2=0.876,P>0.05;?~2=0.252,P>0.05;?~2=1.571,P>0.05;?~2=3.323,P>0.05,respectively).The main toxic reaction during chemotherapy were dyspepsia(28.57%),anemia(26.53%),and leukopenia(22.45%),all of which were mild.Conclusions1.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;2.The 1-year survival rate of stage II,III and IV in both groups decreased in turn,suggesting that early diagnosis and treatment have positive significance in improving patient prognosis and improving survival rate.