Adjuvant Pancreatic ca 2017

ESPAC-4 trialEurope 2017

Gemcitabine plus capecitabine

• ESPAC-4 trial• 730 pts macro resected (R0 or R1) • six months of gemcitabine (1000 mg/m2 on

days 1, 8, and 15 of each 28-day cycle) + capecitabine (1660 mg/m2 per day on days 1 through 21 of each 28-day cycle)

Chch of pts

• The majority of patients in both arms had microscopically positive (R1) resection margins (60 percent) and positive lymph nodes (80 percent).

adverse effects

• Of the grade 3 or 4 adverse effects, diarrhea (5 versus 2 percent), hand foot syndrome (7 versus 0 percent), and neutropenia (38 versus 24 percent) were significantly more common with combined therapy, although there were no significant differences in the rates of treatment-related serious adverse events.

At a median follow-up of 43 months

• combination therapy was associated with a significant survival benefit (median overall survival 28 versus 25.5 months, HR for death 0.82, 95% CI 0.68-0.98).

• At five years, twice as many patients remained alive in the combination therapy group (19 versus 9).