Gemcitabine plus capecitabine improves survival for patients with pancreatic cancer over gemcitabine monotherapy, according to a study being presented at the American Society of Clinical Oncology (ASCO)’s 2016 meeting.1
In this multicenter, international, open-label randomized controlled phase 3 study, 732 patients with pancreatic ductal adenocarcinoma were enrolled and placed randomly in the gemcitabine plus capecitabine or gemcitabine only arm. Seven hundred and thirty patients were included in the final data set, of which 364 were assigned to the gemcitabine plus capecitabine arm, while 366 were assigned to gemcitabine monotherapy.
Results showed that median survival was 3.5 months longer for patients receiving the adjuvant combination therapy than for those who received gemcitabine only (28.0 [95% CI, 23.5-31.5] versus 25.5 [95% CI, 22.7-27.9], respectively). The authors concluded that these results are statistically significant.
Two hundred and twenty-six patients receiving both therapies reported 608 grade 3 or 4 adverse events, while 196 of 366 patients receiving gemcitabine only reported 481 grade 3 or 4 adverse events (P = .242).
1. Neoptolemos JP, Palmer D, Ghaneh P, Valle JW, Cunningham D, Wadsley J, et al. ESPAC-4: A multicenter, international, open-label randomized controlled phase III trial of adjuvant combination chemotherapy of gemcitabine (GEM) and capecitabine (CAP) versus monotherapy gemcitabine in patients with resected pancreatic ductal adenocarcinoma. J Clin Oncol. 2016; 34 (suppl; abstr LBA4006).