Single-center Retrospective Analysis Of Chemotherapy In Patients With Advanced Biliary Tract Cancer And The Exploration Of The HER2 Gene Amplification/Expression For Gallbladder Cancer

Objective:To compare the efficacy of different regimens as first-line and second-line therapy and investigate the prognostic factors for patients with advanced biliary tract cancer.Method:The clinical data of 151 cases with advanced biliary tract cancer who received chemotherapy were included in the retrospective analysis,the objective response rate(ORR)was analyzed by Chi-square test or Fisher’s exact test;potential prognostic factors for survival were evaluated using Cox’s proportional hazards models.Result:The median duration of first-line chemotherapy was 4.0(1.0～10.0)cycles.Two protocols were applied:104 patients(68.9%)received gemcitabine-based regimen(combined with platinums or fluorouracils)or a combination of platinums and fluorouracils,47 patients(30.7%).received a combination of albumin-bound paclitaxel and S-1.The ORR of first-line chemotherapy was 19.5%,and the disease control rate(DCR)was 72.3%.The median PFS was 4.5(95%CI:3.5-5.4)months.The median OS was 13.0(95%CI:10.4-15.6)months.72 patients received second-line therapy(60 patients with available data),the ORR of second-line chemotherapy was 10%,and the DCR was 38.3%.The median PFS was 2.3(95%CI:1.0-3.2)months.The median OS was 7.2(95%CI:4.8-9.5)months.Univariate survival analysis showed that,positive liver metastasis and elevated CA199 level were significantly correlated with worse OS(HR=1.540,95%CI 1.019-2.328,p=0.040 and HR=1.892,95%CI 1.123-3.188,p=0.017);multivariate analysis revealed that elevated CA199 level was an independent factors for OS of patients with advanced BTC.Conclusion:For advanced BTC,the available regimens for first-line chemotherapy could only prolong the survival to about 1 year.Besides conventional regimens containing gemcitabine,platinums and fluorouracils,the combination of albumin-bound paclitaxel and S-1 seems to be an effective chemotherapeutic regimen in patients with advanced BTC.The administration of second-line chemotherapy is insufficient and ineffective,irinotecan-based regimen deserve further investigation.Positive liver metastasis and elevated CA199 level may be risk factors for advanced BTC.Objective:To evaluate the amplification/over-expression of human epidermal growth factor receptor 2(HER2)gene in Chinese people with gallbladder cancer(GBC)and investigate the association of HER2 gene amplification/over-expression with clinicopathological features and clinical outcomes.Method:Tumor specimens which meet the conditions were collected from 61 patients with GBC who received surgery in our center from January 2011 to December 2016.The HER2 protein expression and HER2 gene amplification were detected by immunohistochemistry(IHC)and fluorescence in situ hybridization(FISH)two methods in all cases,respectively.Association between HER2 gene amplification/expression status with clinicopathologic characteristics and survival analysis was analyzed by chi-square test and Kaplan-Meier method respectively.Potential prognostic factors for survival were evaluated using Cox’s proportional hazards models.Results:HER2 gene amplification/over-expression was observed in 19.7%of all cases(n=12).The correlations between HER2 gene amplification/over-expression and blood vessel invasion and metastatic lymph node status and were significant(p=0.002 and p=0.018,respectively).3 year survival rate of the HER2 gene amplification/over-expression group was only 16.7%compared to 53.3%among patients without HER2 gene amplification/over-expression(p=0.056)。For patients who received R0 surgery(n=50),3 year relapse-free survival rate were 20.0%and 63.9%respectively for each group(p=0.041)while 3 year survival rate for each group were 20.0%and 66.7%respectively(p=0.017).Conclusion:The amplification/over-expression of HER2 gene is related to worser clinicopathologic characteristics and may be a risk factor for survival outcomes of gallbladder cancer.