ESPAC-3(v2): a multicentre, international, open label, randomised controlled phase III trial of adjuvant 5-fluorouracil/folinic acid (5-FU/FA) versus gemcitabine (GEM) in patients with resected pancreatic ductal adenocarcinoma


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J Neoptolemos, M Bchler, D D Stocken, P Ghaneh, D Smith, C Bassi, M Moore, D Cunningham, C Dervenis, D Goldstein

For the ESPAC Group. University of Liverpool; University of Heidelberg; University of Birmingham; Clatterbridge Centre for Oncology; University of Verona; Princess Margaret Hospital, Toronto; Royal Marsden Hospital; Agia Olga Hospital, Athens; Prince of Wales Hospital, Sydney

Abstract

Background
Adjuvant 5-FU/FA (ESPAC-1 trial) and GEM (CONKO-001 trial) provide improved survival for patients with resected pancreatic cancer compared to no chemotherapy. The aim of the ESPAC-3 (v2) trial was to compare 5FU/FA vs GEM to identify if either adjuvant chemotherapy was associated with a significantly better survival.

Method
Patients with an R0/R1 resection for pancreatic ductal adenocarcinoma were randomised (stratified for resection margin status and country) <8 weeks of surgery to receive either 5FU/FA (FA, 20 mg/m2, iv bolus injection followed by 5-FU, 425 mg/m2, iv bolus injection given 1-5d every 28 days) or GEM (1000mg/m2 iv infusion 1d, 8d and 15d every 4 weeks) for 6 months. The primary outcome measure was overall survival; the secondary measures were toxicity, progression free survival and quality of life. 1030 patients were needed to detect a 10% difference in 2-year survival rates with 90% power.

Results
1088 patients from 16 countries were randomised