Results from a phase III study published in the New England Journal of Medicine
showed that the chemotherapy combination of oxaliplatin/irinotecan/fluorouracil/leucovorin (FOLFIRINOX) nearly doubled the survival time for patients with pancreatic adenocarcinoma. However, the toxicity of the FOLFIRINOX combo was determined to be considerably higher than that of gemcitabine (Gemzar), which is used alone and in combination with other drugs as the standard treatment for advanced pancreatic cancer.
The French research team that conducted the study in patients with advanced pancreatic adenocarcinoma treated half the group of 342 patients with FOLFIRINOX and the other half with gemcitabine. The average survival time for those in the FOLFIRINOX group was 11.1 months compared to an average of 6.8 months for those in the gemcitabine group.
There were similar encouraging results for progression-free survival (PFS) in the FOLFIRINOX arm. Patients receiving FOLFIRINOX had a median PFS of 6.4 months, whereas the gemcitabine group had a median PFS of 3.3 months. Progression-free survival at 6, 12, and 18 months was 52.8%, 12.1%, and 3.3% for FOLFIRINOX and 17.2%, 3.5%, and 0% for gemcitabine. Only two patients—one from each arm—died of treatment-related cause.
Overall, there were more side effects for the patients in the FOLFIRINOX group. Side effects typically included neutropenia and febrile neutropenia, thrombocytopenia, diarrhea, and sensory neuropathy. Despite the higher incidence of adverse effects associated with the FOLFIRINOX regimen, the study showed a significant increase in the time to definitive deterioration of quality of life in patients in the FOLFIRINOX group versus the gemcitabine group.
Still, the researchers are encouraged by these results, given that pancreatic adenocarcinoma was the fourth leading cause of cancer deaths in the United States in 2010 and that the FOLFIRINOX combo can potentially add months, if not years, to a patient’s life. It should be noted, however, that only a small minority of patients with pancreatic adenocarcinoma were even healthy enough to participate in the study in the first place. One requirement for participation in the trial was that study participants be fully active; those not able to carry out daily activities were not eligible. This made the study sample, whose average age was 61, somewhat remarkable, as patients who are newly diagnosed with pancreatic adenocarcinoma are often seriously ill.