The European Study Group for Pancreatic Cancer (ESPAC) assessed the roles of adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer.
In the study, 541 eligible patients with pancreatic ductal adenocarcinoma were randomly assigned to either adjuvant chemoradiotherapy or chemotherapy, following resection.
The chemoradiotherapy regimen consisted of 20 Gy in 10 daily fractions over 2 weeks, with 500 mg/m2 fluorouracil intravenously on days 1-3, repeated after 2 weeks.
Chemotherapy comprised of intravenous fluorouracil 425 mg/m2 and folinic acid 20 mg/m2 daily for 5 days, and monthly for 6 months.
Clinicians randomized patients into a two-by-two factorial design (observation, chemoradiotherapy alone, chemotherapy alone, or both) or into one of the main treatment comparisons (chemoradiotherapy versus no chemoradiotherapy or chemotherapy versus no chemotherapy).
The primary endpoint was death, and all analyses were by intention to treat.
|Median survival, in months:|
No chemoradiotherapy: 16.1
No chemotherapy: 14.0
Of the patients, 285 were included in the two-by-two factorial design (70 chemoradiotherapy, 74 chemotherapy, 72 both, 69 observation).
A further 68 patients were randomly assigned chemoradiotherapy or no chemoradiotherapy, and 188 chemotherapy or no chemotherapy.
Median follow-up of the 227 (42%) patients still alive was 10 months.
Overall results showed no benefit for adjuvant chemoradiotherapy (median survival 15·5 months in 175 patients with chemoradiotherapy vs 16·1 months in 178 patients without; hazard ratio 1·18).
The researchers found that there was evidence of a survival benefit for adjuvant chemotherapy (median survival 19·7 months in 238 patients with chemotherapy vs 14·0 months in 235 patients without; hazard ratio 0·66).
Professor J. P. Neoptolemos, of the University of Liverpool, Liverpool, England, concluded on behalf of the team, "This study showed no survival benefit for adjuvant chemoradiotherapy.
"However, it revealed a potential benefit for adjuvant chemotherapy, justifying further randomized controlled trials of adjuvant chemotherapy in pancreatic cancer."