11.10 Postoperative Morbidity and Mortality of Neoadjuvant Therapy after Pancreaticoduodenectomy

K. S. Cools2, H. J. Kim2, J. J. Yeh2, H. K. Sanoff3, K. B. Stitzenberg2  2University Of North Carolina At Chapel Hill,Department Of Surgery,Chapel Hill, NC, USA 3University Of North Carolina At Chapel Hill,Department Of Medicine,Chapel Hill, NC, USA

Introduction:
Although surgical resection remains the only potentially curative treatment for pancreas cancer, neoadjuvant chemotherapy and/or radiation therapy has been increasingly employed to try to downstage patients with borderline resectable tumors. Still, there is a paucity of literature examining outcomes at the population level, for patients who do and do not receive neoadjuvant therapy. The existing studies highlight single/few center experiences, with mixed results. The aim of this study was to compare on a population level, the postoperative morbidity and mortality after pancreaticoduodenectomy (PD) in patients undergoing neoadjuvant therapy versus initial surgery for pancreatic ductal adenocarcinoma (PDA).

Methods:
Using the American College of Surgeons National Surgical Quality Improvement Project (NSQIP) Targeted Pancreatectomy data, we identified patients who underwent a PD for PDA between 2014 and 2015. This database consists of pancreas-specific outcomes from 106 centers in the United States. Patients were grouped based on having received neoadjuvant therapy within 90-days of PD. We used bivariable and multivariable analyses to compare postoperative outcomes between the groups.

Results:
A total of 3,758 patients with PDA underwent PD; 930 (24.7%) received neoadjuvant therapy (13.5% chemotherapy only, 0.8% radiation only, and 10.4% chemoradiation). Those in the neoadjuvant group were more likely to have preoperative biliary stenting (66.2% vs 61.8%, p=0.015), a major vein resection (35.8% vs 17.5%, p<0.001), and longer operating time (413 min vs 364 min, p<0.001). At the time of surgery, those in the neoadjuvant group also had more T1 tumors (10.9% vs 5.1%, p<0.001) and fewer nodes positive (N0 49% vs 28%, p<0.001). There were no differences in 30-day postoperative mortality (1.7% vs 2%, p=0.616) or overall complications (55.9% vs 55.2%, p=0.689). On multivariate analysis, patients who received neoadjuvant therapy had a lower likelihood of pancreatic fistula (OR 0.67, 95% CI 0.49-0.92, p<0.001). On multivariate analysis to identify factors associated with pancreatic fistulas, independent predictors included having initial surgery (OR 1.44, 95% CI 1.07-1.95), preoperative biliary stenting (OR 1.3, 95% CI 1.02-1.7), soft pancreatic tissue (OR 2.96, 95% CI 2.32-3.78), longer operative times (OR 1.06, 95% CI 1.0-1.12), and a normal preoperative albumin (OR 1.41, 95% CI 1.08-1.85).

Conclusion:
Using the robust NSQIP database of over 100 centers, we found that neoadjuvant therapy does not increase the overall postoperative morbidity or mortality of a PD for PDA. There is a decreased likelihood of pancreatic fistulas in patients that receive neoadjuvant therapy.