European Study Group for Pancreatic Cancer-1 interim results: a European randomized study to assess the roles of adjuvant chemotherapy and chemoradiation in resectable pancreatic cancer

Abstract

Abstract Background Pancreatic cancer affects 8–12 per 100 000 population per year in Europe. Following resection, the long-term survival rate is only 10–15 per cent and the role of adjuvant treatment is uncertain. The aims of the study were to answer two questions: (1) whether there is a role for chemoradiation (40 Gy and 5-fluorouracil (5-FU), and (2) whether there is a role for chemotherapy (5-FU–folinic acid (FA)) weekly). Methods A multicentre European prospective randomized controlled trial was organized by the European Study Group for Pancreatic Cancer (ESPAC). A 2 × 2 factorial design was used, asking both questions of the same patient, and a pragmatic design asking only one of the two questions of each patient. The data were reviewed at regular intervals by the Independent Data and Safety Monitoring Committee (IDSMC). Results Some 531 patients with pancreatic ductal adenocarcinoma were randomized from 80 clinicians in 11 countries. Randomization was stratified by resection margin involvement; 82 per cent of patients were negative. Some 239 patients (45 per cent) are alive to date, at a median follow-up of 9 (interquartile range 1–24) months. Preliminary results show no evidence of a benefit for chemoradiation treatment (median survival 14 months with chemoradiation versus 15·7 months without; P = 0·24). There is some evidence of a survival benefit for patients having chemotherapy (median survival 19·5 months versus 13·5 months with no chemotherapy; P = 0·003). The effect is reduced when taking into account whether patients received radiotherapy (P = 0·01), indicating that radiotherapy may reduce the overall benefit of the chemotherapy. The IDSMC recommended closing recruitment to the chemoradiotherapy arm. Conclusion There is no role for adjuvant chemoradiotherapy in pancreatic cancer, but there may be a role for chemotherapy. ESPAC-3 is now randomizing between (1) surgery alone, (2) 5FU–FA and (3) gemcitabine.