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Thierry Conroy, MD, medical oncologist, director, Institut de Cancerologie de Lorraine, discusses the findings with an adjuvant a modified FOLFIRINOX regimen in patients with nonmetastatic pancreatic ductal adenocarcinoma.
Thierry Conroy, MD, medical oncologist, director, Institut de Cancerologie de Lorraine, discusses the findings with an adjuvant a modified FOLFIRINOX (mFOLFIRINOX) regimen in patients with nonmetastatic pancreatic ductal adenocarcinoma.
In a study of 493 patients from 77 centers in Canada and France, the PRODIGE 24/CCTG PA.6 trial evaluated mFOLFIRINOX compared with standard gemcitabine. Phase III findings showed the median overall survival with mFOLFIRINOX was 54.4 versus 35.0 months with gemcitabine, representing a 36% reduction in the risk of death (HR, 0.64; 95% CI, 0.48-0.86; P = .003).
The median follow-up was 43.6 months, which Conroy says is due to the fact that an independent data monitoring committee decided that the results had to be presented and published as soon as possible for ethical reasons.
Findings deemed mFOLFIRINOX a safe regimen, but it did have more toxicities than gemcitabine, Conroy says. A higher rate of diarrhea, mucositis, hand-foot syndrome, and grade 3 fatigue were observed in the mFOLFIRINOX arm, while patients who received gemcitabine had more thrombocytopenia, headache, flu-like symptoms, and transaminase elevation.