| IntroductionPancreatic cancer is one of the malignant cancers with poor prognosis.Gemcitabine is considered as front-line therapy for advanced pancreatic cancer.A lot of phaseⅢrandomized controlled trials(RCTs) compared gemcitabine(GEM)-based combination therapy and gemcitabine alone in patients with advanced pancreatic cancer.They have produced conflicting results.Common effect size can be caculated by pooling results of RCTs by Meta-analysis.Regional intra-arterial infusion allows higher drug concentrations to reach the tumor.Several studies indicates that gemcitabine based intra-arterial chemotherapy may be effective in treating advanced pancreatic cancer. Patients with advanced pancreatic cancer were treated with gemcitabine and platinum based intra-arterial chemotherapy in our hospital and took some effect.Researches indicated that traditional Chinese medicine(TCM) could improve quality of life and prolong survival and was of some advantages in treating advanced pancreatic cancer, which attracted intrests home and abroad.Therefore treating advanced pancreatic cancer with gemcitabine based chemotherapy and TCM is being emphasized by clinical oncologist and warrants further investigaiton.ObjectivesThe the first study aim to compare the survival effect of gemcitabine(GEM)-based combination therapy and gemcitabine alone in patients with advanced pancreatic cancer through Meta analysis in phaseⅢclinical trials.The aim of the second study is to elucidate the survival benefit as well as to identify the prognostic factors of patients with advanced pancreatic cancer who underwent gemcitabine and platinum based intra-arterial chemotherapy.Materials and Methods1.MEDLINE and EMBASE searches were supplemented by information from trial registers of phaseⅢrandomized controlled trials(RCTs) for GEM-based combination therapy and GEM alone for advanced pancreatic cancer.A quantitative meta-analysis was carried out by two reviewers based on the inclusion criteria from all available RCTs.The Meta-analysis involved 6-months and 1-year survival rate, objective remission rate(ORR) and hazard ratio(HR).2.Based on database,a retrospective analysis was performed on patients with advanced pancreatic cancer who underwent gemcitabine and platinum based first-line intra-arterial chemotherapy.Kaplan-Meier method was used to calculate the survival and log-rank test was used to compare the differences between groups.Kaplan-Meyer survival curve for univariate analysis and Cox regression model for multivariate one were used to determine factors predictive of survival.Results1.The results of the Meta-analysis showed that there was significant improvement in the GEM combination group with regard to the 1-year survival rate(RR:0.87, 95%CI:0.78-0.96,P=0.008).7%reduction of death rate was obtained in GEM combination group(HR:0.93,95%CI:0.88-0.98,P=0.005).The other results of our Meta-analysis showed no significant difference between two groups.2.Data of 102 patients with advanced pancreatic cancer who underwent gemcitabine and platinum based first-line intra-arterial chemotherapy were analyzed. Median overall survival was 5.8 months(95%CI:5.14-6.46).6-months,1-year and 3-year survival rate was 46.1%,18.6%and 4.9%respectively.Log-rank test indicated that survival benefit was obtained in metastatic cases by adding Pirarubicin(THP) intra-arterially to gemcitabine and platinum combination regimen.Median overall survival for THP group was 5.9 months and 4.4 months for non-THP group(P=0.017). Radiotherapy,indicated by log-rank test,had significant influence on survival as well. Median overall survival for radiotherapy group was 6.0 months and 4.3 months for non-radiotherapy group(P=0.014).In both univariate and multivariate analyses, ascites(X1),CA19-9(X2),stage of disease(X3) and radiotherapy(X4) were significant and independent predictors of survival.Prognostic index PI=2.112X1+0.592X2+0.647X3-0.660X4 was established according to these factors. With the increasing of PI,the survival time showed a tendency of decline(P＜0.05).Conclusions1.The results of the Meta-analysis indicated that GEM-based combination group has higher 1-year survival rate and lower hazard ratio(HR) than GEM single-agent group.GEM-based combination therapy may be effective with regard to the survival improment compared with GEM alone.2.The retrospective analysis of 102 patients showed that:(1) Radiotherapy is recommended to patients with advanced pancreatic cancer who underwent gemcitabine and platinum based intra-arterial chemotherapy and THP intra arterially to metastatic cases.(2) Ascites,CA19-9,stage of disease an radiotherapy are independent prognostic factors in a multivariate analysis of patients with advanced pancreatic cancer who underwent gemcitabine and platinum based intra-arterial chemotherapy.The prognostic model established according to these factors can be used in prognosis estimation.
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