Biliary stent complications in clinical trials for advanced pancreatic cancer.

Abstract

e14665 Background: Most patients (pts) with pancreatic cancer are unresectable at diagnosis. About 70% of these pts will develop obstructive jaundice requiring intervention. Most commonly, relief of obstruction is performed endoscopically, with placement of either a plastic stent (PS) or metal stent (MS). NCCN guidelines recommend metal stents because of a lower occlusion rate. We did a retrospective analysis of biliary stent outcomes in pts with advanced pancreatic cancer (APC) who were treated on a series of phase II trials at UCSF. Methods: We reviewed charts of pts with previously untreated APC who were enrolled on 3 sequential trials that investigated gemcitabine-based combination chemotherapy regimens. Primary objective: to determine biliary stent outcomes including stent complication rate, rate of treatment (tx) delays due to stent complications, and total # of endoscopic interventions per pt. Outcomes were compared for pts with PS vs MS. Results: 134 pts with APC were identified. Median age = 59, and all pts were ECOG PS 0-1. 59 pts (44%) had primary lesions in the pancreatic head/uncinate. 20 pts (15%) had palliative bypass surgery at diagnosis. Of the remaining pts, 22 (19%) required intervention for biliary obstruction prior to the start of tx. Nine pts had MS, 13 had PS in place at the start of tx. Pts with PS were put on a regular schedule of stent exchanges. Seven pts (54%) in the PS group had stent complications during tx; in the MS group 2 pts (22%) had complications. These episodes led to tx delays in 4 pts (31%) in the PS group. There were no tx delays attributable to stent complications in the MS group. The average # of endoscopic or percutaneous procedures performed after the start of tx was 2.85 in the PS group and 1 in the MS group. Of pts who started tx with a PS, 62% ultimately had a MS placed. Conclusions: In our population of clinical trial APC pts, there was a higher rate of complications in pts with PS despite scheduled stent exchanges. This data supports placement of metal stents, especially if pts will be treated with more myelosuppressive combination chemotherapy regimens.