A long-term analysis of the phase III ESPAC4 trial reveals that adjuvant gemcitabine-capecitabine (GemCap) significantly improves overall survival compared to gemcitabine monotherapy in patients with pancreatic adenocarcinoma. The study, published in the Journal of Clinical Oncology, highlights the potential of GemCap as a standard adjuvant treatment option, especially for patients ineligible for mFOLFIRINOX.
The open-label trial, conducted across multiple sites in Europe, randomized 730 patients between November 2008 and September 2014 to receive either adjuvant GemCap (n = 364) or gemcitabine (n = 366). The overall survival analysis was performed after a median follow-up of 104 months (95% CI = 101–108 months).
Survival Benefits of Gemcitabine-Capecitabine
The median overall survival among all patients was 29.5 months (95% CI = 27.5–32.1 months). Specifically, the GemCap arm showed a median overall survival of 31.6 months (95% CI = 26.5–38.0 months), while the gemcitabine arm showed 28.4 months (95% CI = 25.2–32.0 months), resulting in a hazard ratio of 0.83 (95% CI = 0.71–0.98, P = .031).
Impact on R0 Resection Patients
Notably, patients with R0 resection experienced a more pronounced benefit from GemCap. The median overall survival in this subgroup was 49.9 months (95% CI = 39.0–82.3 months) for GemCap compared to 32.2 months (95% CI = 27.9–41.6 months) for gemcitabine, with a hazard ratio of 0.63 (0.47–0.84, P = .002).
Efficacy in Lymph Node-Negative Patients
Further analysis revealed that among lymph node-negative patients, the 5-year overall survival rate was 59% (95% CI = 49%–71%) in the GemCap group versus 53% (95% CI = 42%–66%) in the gemcitabine group (HR = 0.63, 95% CI = 0.41–0.98, P = .04). No significant difference was observed in patients with lymph node-positive disease.
Clinical Implications
The study's findings suggest that GemCap is a valuable treatment option for patients with pancreatic adenocarcinoma, particularly those who are not eligible for mFOLFIRINOX. According to the investigators, "GemCap is a standard option for patients not eligible for mFOLFIRINOX. Exploratory evidence suggests that GemCap may be particularly efficacious in R0 patients and also in lymph node-negative patients."
