ESPAC-5: immediate surgery versus short-course neoadjuvant chemotherapy or chemoradiotherapy in borderline resectable pancreatic cancer
In borderline resectable pancreatic cancer, two months of chemotherapy before surgery did not change how many tumours could be removed but was followed by far better one-year survival than going straight to surgery.
Overview
Four-arm randomised phase 2 feasibility trial at 16 sites: 90 patients with borderline resectable pancreatic cancer were randomised to immediate surgery (33), neoadjuvant gemcitabine plus capecitabine (20), FOLFIRINOX (20) or capecitabine-based chemoradiotherapy (17); 86 were analysed.
Resection rates were 68 percent after immediate surgery and 55 percent after neoadjuvant therapy (p 0.33), with R0 rates of 14 and 23 percent. One-year overall survival was 39 percent with immediate surgery against 78, 84 and 60 percent in the three neoadjuvant arms (p 0.0028); one-year disease-free survival from surgery was 33 against 59 percent (hazard ratio 0.53).
- One-year overall survival 39 percent (95% CI 24 to 61) with immediate surgery versus 78 percent (gemcitabine plus capecitabine), 84 percent (FOLFIRINOX) and 60 percent (chemoradiotherapy); p 0.0028.
- Resection 68 versus 55 percent (p 0.33); R0 resection 14 versus 23 percent (p 0.49).
- One-year disease-free survival from surgery 33 versus 59 percent; hazard ratio 0.53 (0.28 to 0.98), p 0.016.
Supports neoadjuvant therapy, preferably chemotherapy, for borderline resectable pancreatic cancer while larger trials define the regimen.
- Feasibility design with small arms and a survival difference that was a secondary outcome.
- Median follow-up only 12.2 months.
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