Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial

Background The role of adjuvant treatment in pancreatic cancer remains unce rtain. The European Study Group for Pancreatic Cancer (ESPAC) assessed the roles of chemoradiotherapy and chemotherapy in a randomised study. Methods After resection, patients were randomly assigned to adjuvant chemor adiotherapy (20 Gy in ten daily fractions over 2 weeks with 500 mg/m(2) flu orouracil intravenously on days 1-3, repeated after 2 weeks) or chemotherap y (intravenous fluorouracil 425 mg/m(2) and folinic acid 20 mg/m(2) daily f or 5 days, monthly for 6 months). Clinicians could randomise patients into a two-by-two factorial design (observation, chemoradiotherapy alone, chemot herapy alone, or both) or into one of the main treatment comparisons (chemo radiotherapy versus no chemoradiotherapy or chemotherapy versus no chemothe rapy). The primary endpoint was death, and all analyses were by intention t o treat. Findings 541 eligible patients with pancreatic ductal adenocarcinoma were r andomised: 285 in the two-by-two factorial design (70 chemoradiotherapy, 74 chemotherapy, 72 both, 69 observation); a further 68 patients were randoml y assigned chemoradiotherapy or no chemoradiotherapy and 188 chemotherapy o r no chemotherapy. Median follow-up of the 227 (42%) patients still alive w as 10 months (range 0-62). Overall results showed no benefit for adjuvant c hemoradiotherapy (median survival 15.5 months in 175 patients with chemorad iotherapy vs 16.1 months in 178 patients without; hazard ratio 1.18 [95% CI 0.90-1-55], p=0.24). There was evidence of a survival benefit for adjuvant chemotherapy (median survival 19.7 months in 238 patients with chemotherap y vs 14.0 months in 235 patients without; hazard ratio 0.66 [0.52-0.83], p= 0.0005). Interpretation This study showed no survival benefit for adjuvant chemoradi otherapy but revealed a potential benefit for adjuvant chemotherapy, justif ying further randomised controlled trials of adjuvant chemotherapy in pancr eatic cancer.