Neoadjuvant FOLFOX + NAB-paclitaxel (FOLFOX-A) in locally advanced pancreatic cancer

Abstract

Objective: A phase I study recently conducted at our institution using FOLFOX and Nab-Paclitaxel in patients with advanced pancreatic cancer (11 locally advanced, 24 metastatic) determined the maximum tolerated dose of Abraxane with FOLFOX to be 150 mg/m every 2 weeks. We present a subset analysis of eleven patients with locally advanced disease treated with FOLFOX-A. Methods: We conducted a subset analysis of patients with biopsy confirmed locally advanced pancreatic cancer between November 2012 to September 2014 who were treated with FOLFOX-A in a prospective phase 1 dose escalation trial. Outcomes evaluated were conversion to operative resection, resection margin negativity and operative morbidity. Results: Four of 11 (36.3%) patients with locally advanced disease were able to undergo resection following study treatment: pancreaticoduodenectomy (3), subtotal pancreatectomy, (1). Median follow-up time was 18 months. An R0 resection was achieved in 4/4 patients. Patients receiving neoadjuvant FOLFOX-A had a high rate of complications: chyle leak (1), GI bleed (1), pancreatic leak (2) and high EBL (500–1600 cc). There were no operative mortalities. Reoperation was required in 1 patient for portal vein thrombosis. Two of 4 patients remain alive, one without evidence of disease. Conclusion: FOLFOX-A shows promise as a novel neoadjuvant therapy for locally advanced pancreatic cancer. We are currently conducting a phase II prospective trial of Neoadjuvant FOLFOX-A for locally advanced pancreatic adenocarcinoma to better define patient survival and operative morbidity.