In a long-term analysis of the phase III ESPAC4 trial reported in Journal of Clinical Oncology, Palmer et al found adjuvant gemcitabine/capecitabine (Gem/Cap) was associated with prolonged overall survival vs gemcitabine monotherapy in patients with pancreatic adenocarcinoma.
Study Details
In the open-label trial, 730 eligible patients from sites in England, Scotland, Wales, Germany, France, and Sweden were randomly assigned between November 2008 and September 2014 to receive adjuvant gemcitabine/capecitabine (n = 364) or gemcitabine (n = 366). The current analysis of overall survival was performed after a median follow-up of 104 months (95% confidence interval [CI] = 101–108 months).
Key Findings
Median overall survival among all patients was 29.5 months (95% CI = 27.5–32.1 months). Median overall survival was 31.6 months (95% CI = 26.5–38.0 months) with gemcitabine/capecitabine vs 28.4 months (95% CI = 25.2–32.0 months) with gemcitabine alone (hazard ratio [HR] = 0.83, 95% CI = 0.71–0.98, P = .031).
Among patients with R0 resection, median overall survival was 49.9 months (95% CI = 39.0–82.3 months) for patients in the gemcitabine/capecitabine group vs 32.2 months (95% CI = 27.9–41.6 months) for those in the gemcitabine group (HR = 0.63, 0.47–0.84, P = .002). Among lymph node–negative patients, the 5-year overall survival rate was 59% (95% CI = 49%–71%) in the gemcitabine/capecitabine group vs 53% (95% CI = 42%–66%) in the gemcitabine group (HR = 0.63, 95% CI = 0.41–0.98, P = .04); no between-group difference in rates was observed among patients with lymph node–positive disease.
The investigators concluded: “GemCap is a standard option for patients not eligible for mFOLFIRINOX [modified fluorouracil, folinic acid, irinotecan, and oxaliplatin]. Exploratory evidence suggests that GemCap may be particularly efficacious in R0 patients and also in lymph node-negative patients.”
John P. Neoptolemos, MD, of Heidelberg University Hospital, Germany, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by Cancer Research UK. For full disclosures of the study authors, visit ascopubs.org.
