2. 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)
3. Chch of pts
• The majority of patients in both arms had
microscopically positive (R1) resection
margins (60 percent) and positive lymph
nodes (80 percent).
4. 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.
5. 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).