ESPAC-4: adjuvant gemcitabine and capecitabine versus gemcitabine monotherapy in resected pancreatic cancer
Adding capecitabine to gemcitabine after pancreatic cancer surgery lengthened median survival from 25.5 to 28 months, making the combination a new adjuvant standard.
Overview
Open-label phase 3 trial at 92 hospitals in the United Kingdom, Germany, France and Sweden: 730 analysed patients with resected pancreatic ductal adenocarcinoma were randomised to six cycles of gemcitabine (366) or gemcitabine plus capecitabine (364).
Median overall survival was 28.0 months with the combination against 25.5 months with gemcitabine (hazard ratio 0.82, p 0.032). Grade 3 to 4 adverse events: 608 in 226 of 359 combination patients against 481 in 196 of 366 gemcitabine patients.
- Median overall survival 28.0 months (95% CI 23.5 to 31.5) versus 25.5 months (22.7 to 27.9); hazard ratio 0.82 (0.68 to 0.98), p 0.032.
- Grade 3 to 4 adverse events in 226 of 359 versus 196 of 366 patients.
Gemcitabine plus capecitabine became the adjuvant standard after resection and remains the option for patients unfit for modified FOLFIRINOX.
- Reported early at the monitoring committee's request after 95 percent of target deaths.
- Registered with ISRCTN only (ISRCTN96397434).
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