The GEMOXEL (gemcitabine, oxaliplatin, capecitabine) regimen may be safe and more efficient than standard therapy with gemcitabine alone in the treatment of patients with metastatic pancreatic cancer, a study published in the journalCancer Chemotherapy and Pharmacology has shown.
For this phase II study, researchers sought to compare the activity and safety of the GEMOXEL regimen versus gemcitabine alone in patients with metastatic pancreatic cancer.
Researchers enrolled 67 patients and randomly assigned them 1:1 to receive gemcitabine 1,000mg/m2 IV on days 1, 8, 15, and 22, oxaliplatin 100mg/m2 IV on day 2, and capecitabine 1,500mg/m2/day on days 1-14 of each 21-day cycle or gemcitabine alone.
All participants received gemcitabine weekly for 7 consecutive weeks followed by 1-week rest for the first 8 weeks. Then, gemcitabine was continued on days 1, 8, and 15 every 28 days.
RELATED: New, Less Aggresssive Guidelines for Pancreatic Cysts
Results showed that the median progression-free survival was 6.8 months (95% CI: 5.3-7.3) and 3.7 months (95% CI: 2.9-4.7) in the GEMOXEL and gemcitabine arms, respectively (P < 0.001).
Researchers found that median overall survival was 11.9 months (95% CI: 10.6-12.9) in the GEMOXEL arm and 7.1 months (95% CI: 5.5-9.1) in the gemcitabine arm (P < 0.001).
In regard to safety, toxicities were more severe with GEMOXEL than gemcitabine alone, but still tolerable. No patients experienced grade 4 adverse events.