722P - A Pilot Trial of Gemcitabine in Combination with Capecitabine or Erlotinib Compared to Gemcitabine alone in Patients with advanced Pancreatic Cancer

Abstract

ABSTRACT Aims This pilot study was designed to compare the survival benefit of gemcitabine plus capecitabine (GEM-X) or gemcitabine plus erlotinib (GEM-T) over gemcitabine alone (GEM) in patients with locally advanced or metastatic pancreatic cancer. Methods Patients with previously untreated locally advanced or metastatic carcinoma of the pancreas were recruited. Patients were assigned to GEM, GEM-T, or GEM-X. The primary end points were the overall survival (OS) and response rate. Results A total of 127 patients were assigned to receive GEM (n = 47), GEM-T (n = 44), and GEM-X (n = 36). GEM-X significantly improved the objective response rate (21.2% vs. 12.7% and 15.9%) and the overall disease control rate (partial response plus stable disease; 72.7% vs. 63.8% and 59.1%) compared to GEM and GEM-T, respectively. Progression-free survival was significantly prolonged in the GEM-X group compared to the GEM and GEM-T groups (median, 8.9 months vs. 5.2 and 3.9 months, respectively; P Conclusions GEM-X is plausible first-line treatment for locally advanced and metastatic pancreatic cancers. GEM-X was superior to GEM and GEM-T accompanying acceptable levels of toxicity, and GEM-T showed similar efficacy to GEM. It is of clinical value to perform a phase III trial to compare gemcitabine plus capecitabine and gemcitabine plus erlotinib in pancreatic cancer patients. Disclosure All authors have declared no conflicts of interest.