Phase II Clinical Trial to Evaluate the Efficacy and Safety of Activated T-Lymphocyte Cell Therapy in Gemcitabine Refractory Advanced Pancreatic Cancer

Abstract

high volume multidisciplinary pancreas center. Independent two-sample t-tests were used to compare continuous variables, and chi-squared tests were used to compare categorical variables. Kaplan-Meier methods were employed to initially test survival between groups and then Cox-Proportional Hazard Models were used to control for additional variables. Results: We identified 6031 patients in the SEER database and 345 patients (5.7% of the national total) at a high-volume single center, who had resection for pancreatic adenocarcinoma between 1993-2007. There was no difference in the average age (65.4 vs. 65.2) or sex (49.5% vs. 49.6% male) of the patients in the two groups (p>0.05). Using SEER historic staging criteria (localized, regional, distant), cancers resected in the SEER group were broken down as 12.6% localized, 71.0% regional, and 16.4% distant. Cancers resected at the high volume center were broken down as 36.8% localized, 62.3% regional, and 0.9% distant. There was therefore, a higher proportion of resectable cancers (localized + regional) undergoing surgery at the high volume center compared to the SEER group (99% vs 84%, p= 0.031). Only 1% of patients taken for surgery at the single center were not resectable because of distant disease. 22.6% of patients at the single center had vascular reconstruction representing a technically difficult operation with high morbidity and mortality. 5-year survival was significantly increased in the high volume versus the SEER group (12.46% vs. 5.37%) by Kaplan-Meier methods (p<0.001), but as expected, not by Cox-Proportional Hazard Models controlling for stage, age, sex, and year of surgery (HR 1.012, 95%CI 0.892-1.149, p=0.848). Conclusions: Increased survival of patients with resected pancreatic adenocarcinoma seen in a high-volume multidisciplinary pancreas center may be explained by more prudent identification of resectable cases. This is likely secondary to better preoperative detection, staging, and multidisciplinary expertise. Dedicated high-volume centers are an important means of improving survival from pancreas cancer.