Phase II Study of Adjuvant Chemotherapy With Gemcitabine and Nafamostat Mesilate for Pancreatic Cancer.

OBJECTIVES The aim of this study was to clarify the effectiveness of combination chemotherapy targeting gemcitabine (GEM)-induced nuclear factor kappa B as adjuvant therapy for pancreatic cancer. METHODS Patients who were planned after curative surgery (residual tumor classification R0 or R1) for pancreatic cancer to receive six cycles of adjuvant chemotherapy of regional arterial infusion of nafamostat mesilate with GEM between June 2011 and April 2017 were enrolled in this single-center, institutional review board-approved phase II trial (UMIN000006163). The Kaplan-Meier method was used to estimate disease-free survival and overall survival. RESULTS In 32 patients [male/female: 18/14; age: median, 65.5 years (range, 48-77 years); pathological stage (Union for International Cancer Control 8th): IA/IB/IIA/IIB/III, 2/2/9/18/1, respectively] who met the eligibility criteria, the median overall survival and disease-free survival were 36.4 months (95% confidence interval, 31.7-48.3) and 16.4 months (95% confidence interval, 14.3-22.0), respectively. Grade 4 treatment-related hematological toxicities were seen in 5 patients (15.6%) (all neutropenia). One patient developed grade 3 nonhematological toxicities (rash). CONCLUSIONS Adjuvant chemotherapy with regional arterial infusion of nafamostat mesilate and GEM is safe and has potential as an option in adjuvant setting after curative surgery for pancreatic cancer.