The introduction of the FOLFIRINOX regimen within the last decade marked the first progress in the clinical field of metastatic pancreatic cancer which had not seen any improvements in treatment availability for several years. In a phase III randomized clinical trial, FOLFIRINOX showed superior efficacy compared to the previous standard treatment of gemcitabine monotherapy. Nevertheless, it is unknown whether the superior results observed in this single phase III clinical trial can be translated more broadly to clinical practice. Our investigation sought to analyze all published evidence of the FOLFIRINOX regimen in series and phase II trials and compare it to the experience of the phase III study. Survival analysis revealed that FOLFIRINOX was associated with an Overall Survival of 10-11 months both in the trials and in off-trial settings, with response rates also similar in both settings. The adverse effect profile was consistent between the pooled phase II and off-trial experience and the FOLFIRINOX regimen arm observed in the randomized phase III trial.
Keywords: FOLFIRINOX; adverse effects; chemotherapy; efficacy outcomes; pancreatic cancer.