Sepsis and pancreatic cancer: Biliary stents a significant risk factor in patients undergoing chemotherapy.

Abstract

399 Background: For patients with pancreatic cancer, tumor growth causing obstruction of the bile duct is a common, yet troubling occurrence, leading to potential serious complications including severe infections. A common technique to correct such an occurrence is the placement of a biliary stent. However, a biliary stent can cause a separate series of complications, especially for patients receiving chemotherapy. A current standard of care treatment for locally advanced pancreatic cancer is intravenous (IV) infusion of gemcitabine and nab-paclitaxel, with the prescribing information for these drugs noting that 5% of patients have experienced sepsis, with those having biliary stents potentially becoming fatal. Methods: In an on-going phase III clinical trial comparing standard of care IV gemcitabine and nab-paclitaxel versus intra-arterial delivery of gemcitabine directly to the tumor via a novel dual-occlusion balloon catheter, data from the cohort of 78 patients (total enrolled as of 1 June 2020) were analyzed for the incidence rate of sepsis among patients with and without biliary stents present. Data analyzed were limited to the initial four-month induction phase, in which patients were to receive two cycles of IV gemcitabine and nab-paclitaxel, one cycle of either IMRT or SBRT, and then one more cycle of IV gemcitabine and nab-paclitaxel. Results: Among the 78 patients, 12 had one episode of sepsis for an incidence rate of 15%. Of the 78 patients, 39 had a biliary stent placed and 9 experienced sepsis during induction (23%) compared to 2 patients among the 39 without a biliary stent present (5%; Chi-square = 4.99, p = 0.02). One additional patient with a biliary stent experienced urosepsis due to urinary tract infection, unrelated to the biliary stent. The majority of the septic events occurred after placement of the stent during the first cycle of chemotherapy (5 of 9 patients), with an average of 8.2 days passed after a dose of chemotherapy was infused to the septic event (range: 2 to 20 days). There was no relationship between ANC and the risk of sepsis. Among other covariates analyzed, age, gender, BMI, and a history of diabetes were not factors shown to affect the likelihood of a septic event. Among the 9 patients who had a septic event with a biliary stent, 2 were fatal, and 3 were withdrawn from the study due to complications from the septic event. Conclusions: These data suggest while the placement of a biliary stent may alleviate certain complications with biliary obstruction, combined with the immunosuppressive qualities of chemotherapy, the likelihood of sepsis increases, with incidence rates significantly greater than those previously reported in the drugs’ prescribing information or previous studies. The current practice of the insertion of the biliary stent potentially introduces flora during the procedure, resulting in potential infection later with administration of chemotherapy. Clinical trial information: NCT03257033.