Treatment strategies and clinical outcomes in consecutive patients with locally advanced pancreatic cancer: A multicenter prospective cohort.

INTRODUCTION: Since current studies on locally advanced pancreatic cancer (LAPC) mainly report from single, high-volume centers, it is unclear if outcomes can be translated to daily clinical practice. This study provides treatment strategies and clinical outcomes within a multicenter cohort of unselected patients with LAPC. MATERIALS AND METHODS: Consecutive patients with LAPC according to Dutch Pancreatic Cancer Group criteria, were prospectively included in 14 centers from April 2015 until December 2017. A centralized expert panel reviewed response according to RECIST v1.1 and potential surgical resectability. Primary outcome was median overall survival (mOS), stratified for primary treatment strategy. RESULTS: Overall, 422 patients were included, of whom 77% (n = 326) received chemotherapy. The majority started with FOLFIRINOX (77%, 252/326) with a median of six cycles (IQR 4-10). Gemcitabine monotherapy was given to 13% (41/326) of patients and nab-paclitaxel/gemcitabine to 10% (33/326), with a median of two (IQR 3-5) and three (IQR 3-5) cycles respectively. The mOS of the entire cohort was 10 months (95%CI 9-11). In patients treated with FOLFIRINOX, gemcitabine monotherapy, or nab-paclitaxel/gemcitabine, mOS was 14 (95%CI 13-15), 9 (95%CI 8-10), and 9 months (95%CI 8-10), respectively. A resection was performed in 13% (32/252) of patients after FOLFIRINOX, resulting in a mOS of 23 months (95%CI 12-34). CONCLUSION: This multicenter unselected cohort of patients with LAPC resulted in a 14 month mOS and a 13% resection rate after FOLFIRINOX. These data put previous results in perspective, enable us to inform patients with more accurate survival numbers and will support decision-making in clinical practice.

Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease.

OBJECTIVE: Arterial closure devices (ACDs) seem to be safe and effective to obtain hemostasis for cardiac interventions and diagnostic vascular procedures. However, only limited evidence is presented on therapeutic interventions in patients with peripheral atherosclerotic disease. We compared ischemic and hemorrhagic complications of an ACD vs manual compression (MC) after puncture of the femoral artery for endovascular lower extremity procedures. METHODS: The records of all subsequent endovascular interventions for peripheral artery disease performed in a large teaching hospital, from January 2012 to April 2014, were retrospectively reviewed. The primary outcome was an ischemic complication requiring reintervention. Secondary outcomes were hematoma (needing conservative or invasive intervention) and infection (needing intervention or antibiotics). Multivariate analysis was performed to identify predictors for any complication. RESULTS: The Angio-Seal (St. Jude Medical, Minnetonka, Minn) closure device was used in 244 of 463 endovascular interventions (54%). Five patients (2%) who received an ACD needed emergency surgery for ischemic complications vs none in the MC group (P = .06). Hematomas occurred in 22 patients (9%) after ACD vs in six (3%) after MC (adjusted odds ratio [OR], 3.4; 95% confidence interval [CI], 1.4-8.9; P = .015). There were no infections in either group. ACD (OR, 3.8; 95% CI, 1.5-9.7) and current smoking (OR, 2.6; 95% CI, 1.01-6.7) were independent predictors for any complication. CONCLUSIONS: This study demonstrates that ACD use in patients with peripheral artery disease can lead to serious adverse events resulting in increased morbidity. Therefore, the potential benefits of an ACD over MC should be carefully weighed.