P-172 - Efficacy and safety of S-1 and gemcitabine in an unselected Western cohort of patients with unresectable pancreatic cancer

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter P. Pfeiffer
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors P. Pfeiffer, H. Jensen, J. Bjerregaard, K. Schønnemann, M. Weisz, S. Winther
  • Odense University Hospital, Odense/DK

Abstract

Introduction

Gemcitabine (Gem) has been the standard of care for untreated Caucasian patients (pts) with unresectable pancreatic adenocarcinomas (PC) for almost two decades. Randomized, primarily Japanese, studies have shown promising efficacy when combined with S-1 (GemS1), however no data is published in Caucasian patients. In the present study we report our experience with a combination of GemS1 in an unselected cohort of Caucasian pts with PC.

Methods

Patients with metastatic (mPC) and locally advanced PC (LAPC) were treated with Gem 1000 mg/m2 IV day 1 + 8 and S-1 25 mg/m2 BID days 1-14 every 3 weeks. In this observational cohort study, we analyzed all consecutive pts who had received at least one cycle of GemS1 at our department. Efficacy and toxicity were registered prospectively. Progression-free survival (PFS) and overall survival (OS) were estimated from the start of S1 containing chemotherapy using the Kaplan-Meier method.

Results

From July 2012 to July 2014, 64 pts received at least one course of GemS1. Forty-two pts had mPC and twenty-two LAPC. Sixteen pts started therapy with a combination of gem and capecitabine (GemCap) but switched to GemS1 after a median of 2.5 courses due to toxicity (HFS in all cases). In 48 pts the initial therapy was GemS1. Median age was 68 years (range 44-80); 16, 31 and 17 pts were in PS 0, 1, and 2, respectively. The most common adverse event was fatigue (84%), however only grade 3 in 3%. Five patients (8%) developed febrile neutropenia. Median PFS was 9.0 (95% CI: 6.9-11.0) months and the median OS was 11.7 (95% CI: 11.2-16.9) months.

Conclusion

The combination of gemcitabine and S-1 is tolerable with promising efficacy in a Caucasian population with unresectable PC and should be evaluated in prospective clinical trials.