Traditional FOLFIRINOX therapy (fluorouracil, leucovorin, irinotecan, and oxaliplatin) has been established as a more effective therapy among patients with metastatic pancreatic cancer than gemcitabine therapy. This study aims to evaluate the efficacy of the newly modified FOLFIRINOX regimen by comparing it with gemcitabine as adjuvant therapy for pancreatic cancer.

This study included a total of 493 patients with resected pancreatic ductal adenocarcinoma. The patients were randomly assigned to receive a modified FOLFIRINOX regimen or gemcitabine for 24 weeks. The primary outcome of the study was disease-free survival, along with overall survival and safety outcomes.

At the median follow-up of 33.6 months, the median disease-free survival in the modified FOLFIRINOX group was 21.6 months, as compared with 12.8 months in the gemcitabine group. At 3 years, the disease-survival rate in the modified-FOLFIRINOX group and 39.7%, as compared with 21.4% in the gemcitabine group. The median overall survival in the modified-FOLFIRINOX group and the gemcitabine group was 54.4 months and 35.0 months, respectively. The overall rate of survival at 3 years was 63.4% in the modified-FOLFIRINOX group and 48.6% in the gemcitabine group. However, the rate of grade-3 or 4 adverse events was also higher in the modified-FOLFIRINOX group (75.9% vs. 52.9%).

The findings concluded that adjuvant therapy with modified-FOLFIRINOX in patients with pancreatic cancer was associated with improved overall and disease-free survival, but it also had a higher risk of adverse events.

Ref: https://www.nejm.org/doi/full/10.1056/NEJMoa1809775