For patients with resected pancreatic cancer, adjuvant therapy with a modified regimen of chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX), compared with gemcitabine, results in significantly longer survival, according to a study published in the Dec. 20 issue of the New England Journal of Medicine.
Thierry Conroy, M.D., from the Institut de Cancérologie de Lorraine in Vandoeuvre-lès-Nancy, France, and colleagues randomly assigned 493 patients with resected pancreatic ductal adenocarcinoma to receive either a modified FOLFIRINOX regimen or gemcitabine for 24 weeks.
The researchers found median disease-free survival rates of 21.6 and 12.8 months in the modified-FOLFIRINOX and gemcitabine groups, respectively, during a median follow-up of 33.6 months (stratified hazard ratio for cancer-related event, second cancer, or death, 0.58). At three years, disease-free survival rates were 39.7 and 21.4 percent in the modified-FOLFIRINOX and gemcitabine groups, respectively. Median overall survival was 54.4 and 35.0 months, respectively, in the modified-FOLFIRINOX and gemcitabine groups (stratified hazard ratio for death, 0.64). At three years, overall survival rates were 63.4 and 48.6 percent in the modified-FOLFIRINOX and gemcitabine groups, respectively. Grade 3 or 4 adverse events occurred in 75.9 and 52.9 percent of patients in the modified-FOLFIRINOX and gemcitabine groups, respectively.
"This trial represents the culmination of more than a decade of careful work that initially established FOLFIRINOX as a standard treatment for advanced pancreatic cancer," write the authors of an accompanying editorial.
Several authors disclosed financial ties to the pharmaceutical industry; the study was partially funded by R&D Unicancer, which received a grant from Chugai Pharmaceutical.