Adjuvant gemcitabine plus capecitabine should be considered the new standard of care for patients with pancreatic cancer who have undergone tumor resection, according to a multicenter randomized phase 3 trial published in the Lancet. The combination should replace adjuvant gemcitabine monotherapy, the authors concluded.1,2
“This is one of the biggest ever breakthroughs prolonging survival for pancreatic cancer patients,” reported lead author John Neoptolemos, MD, FRCS, from the University of Liverpool in the United Kingdom, in a Cancer Research UK news release.2 “When this combination becomes the new standard of care, it will give many patients living with the disease valuable months and even years.”
The researchers randomly assigned 730 adult patients who had undergone complete macroscopic pancreatic tumor resection at hospitals in the United Kingdom, France, Germany, and Sweden to receive 6 cycles of either 1000 mg/m2 gemcitabine alone once weekly for 3 of every 4 weeks (366 patients) or 1000 mg/m2 gemcitabine once weekly for 3 of every 4 weeks plus 1660 mg/m2 oral capecitabine for 21 days followed by a 7-day rest (364 patients).
Median overall survival for the combination therapy group was 28.0 months (95% CI, 23.5-31.5 months) vs 25.5 months (95% CI, 22.7-27.9 months) among monotherapy-group patients (hazard ratio, 0.82; 95% CI, 0.68-0.98; P =.032).1
Although the absolute difference in short-term survival “may seem modest,” the reported improvement in long-term survival is “substantial” for pancreatic cancer, noted Dr Neoptolemos.2
1. Neoptolemos JP, Palmer DH, Ghaneh P, et al. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial [published online January 24, 2017]. Lancet. doi: 10.1016/S0140-6736(16)32409-6
2. Cancer Research UK. Press release: study establishes new standard of care for pancreatic cancer patients. https://www.eurekalert.org/pub_releases/2017-01/cru-sen012317.php. Published January 24, 2017. Accessed February 9, 2017.