ESPAC4 (long-term analysis)
Trial question
What is the effect of adjuvant chemotherapy with gemcitabine plus capecitabine in patients with pancreatic adenocarcinoma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 732
732 patients (415 female, 317 male).
Inclusion criteria: adult patients with pancreatic adenocarcinoma.
Key exclusion criteria: WHO performance score ≥ 2; CrCl < 50 mL/min; life expectancy < 3 months.
Interventions
N=365 gemcitabine plus capecitabine (intravenous infusion of 1,000 mg/m² gemcitabine once weekly for 3 weeks plus oral dose of 1,660 mg/m² capecitabine per day for 21 days for 6 cycles over 24 weeks).
N=367 gemcitabine (intravenous infusion of 1,000 mg/m² once weekly for 3 weeks comprising 1 cycle for 6 cycles over 24 weeks).
Primary outcome
Median overall survival
31.6 months
28.4 months
31.6 months
23.7 months
15.8 months
7.9 months
0.0 months
Gemcitabine plus
capecitabine
Gemcitabine
Significant
increase ▲
Significant increase in median overall survival (31.6 months vs. 28.4 months; HR 1.2, 95% CI 1.02 to 1.41).
Secondary outcomes
Borderline significant increase in median relapse-free survival (21.3 months vs. 18.3 months; HR 1.18, 95% CI 1 to 1.39).
Significant increase in median survival, R0 status (49.9 months vs. 32.2 months; HR 1.59, 95% CI 1.19 to 2.13).
Significant increase in overall survival at 5 years, lymph node-negative patients (59% vs. 53%; HR 1.59, 95% CI 1.02 to 2.44).
Conclusion
In adult patients with pancreatic adenocarcinoma, gemcitabine plus capecitabine was superior to gemcitabine with respect to median overall survival.
Reference
Daniel H Palmer, Richard Jackson, Christoph Springfeld et al. Pancreatic Adenocarcinoma: Long-Term Outcomes of Adjuvant Therapy in the ESPAC4 Phase III Trial. J Clin Oncol. 2025 Apr;43(10):1240-1253.
Open reference URL