A Pilot Study- Neoadjuvant Chemotherapy with Gemcitabine and S1 in Patients with Resectable and Borderline Resectable Pancreatic Cancer

Abstract

Introduction: Combination chemotherapy with gemcitabine and S-1 (GS) in metastatic advanced pancreatic cancer patients is superior to gemcitabine alone in response rate and progression free survival. We investigated this combination chemotherapy as neoadjuvant therapy for resectable and borderline resectable pancreatic cancer. Methods: Eleven patients with resectable or borderline resectable pancreatic cancer were administered to neoadjuvant chemotherapy with GS (NeoGS) from June 2011 to March 2013 at Nippon Medical School, and shortterm outcome was evaluated. Results: The median age was 69.1 years. According to NCCN criteria, 6 patients were resectable diseases and 5 were borderline resectable diseases. All patients received Neo GS with a median cycle of 3.5 (range: 2-11). No serious adverse events including death or life-threatening complications happened. Grade 3 or 4 chemotherapyrelated toxicities included neutropenia (81.8%), anemia (18.2%), thrombocytopenia (18.2%), and febrile neutropenia (9.1%). Other non-hematological toxicities with grade 1 or 2 were anorexia (36.4%), constipation (36%), nausea (27.3%), diarrhea (18.2%), dysgeusia (9.1%), and stomatitis (9.1%). Radiologically, partial response was documented in 3 patients (27.3%), and the remaining 8 patients (72.7%) had stable disease. All patients underwent pancreatic resection with lymphadenectomy. An R0 resection was achieved in 10 of 11 (90.9%), and negative nodal involvement (N0) was found in 6 (54.5%). Pathologically, all specimens showed at least Evans grade I, while eight of eleven (72.7%) had Evans grade IIa. There was no mortality and severe morbidity including clinically relevant pancreatic fistula. All patients received adjuvant chemotherapy with either gemcitabine or S1. Conclusion: This pilot study suggests NeoGS is feasible in patients with resectable and borderline resectable pancreatic cancer and may be associated with a high R0 resection rate and a low lymph node metastasis rate, suggesting that further phase 2 and 3 trials are warranted.