N. Engl. J. Med.
FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.
Abstract
Background
Data are lacking on the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) as compared with gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.
Methods
We randomly assigned 342 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5, with higher scores indicating a greater severity of illness) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival.
Results
The median overall survival was 11.1 months in the FOLFIRINOX group as compared with 6.8 months in the gemcitabine group (hazard ratio for death, 0.57; 95% confidence interval [CI], 0.45 to 0.73; P<0.001). Median progression-free survival was 6.4 months in the FOLFIRINOX group and 3.3 months in the gemcitabine group (hazard ratio for disease progression, 0.47; 95% CI, 0.37 to 0.59; P<0.001). The objective response rate was 31.6% in the FOLFIRINOX group versus 9.4% in the gemcitabine group (P<0.001). More adverse events were noted in the FOLFIRINOX group; 5.4% of patients in this group had febrile neutropenia. At 6 months, 31% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 66% in the gemcitabine group (hazard ratio, 0.47; 95% CI, 0.30 to 0.70; P<0.001).
Conclusions
As compared with gemcitabine, FOLFIRINOX was associated with a survival advantage and had increased toxicity. FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer and good performance status. (Funded by the French government and others; ClinicalTrials.gov number, NCT00112658.).
Related Questions
In what situations, if any, would you recommend NALIRIFOX over FOLFIRINOX for first-line treatment of patients with unresectable pancreatic cancer?
Given the currently available information, I would not use NALIRIFOX instead of mFOLFIRINOX in any situation.My reasons for this are: mFOLFIRINOX has been the standard of care for the treatment of metastatic and unresectable pancreatic cancer in patients who can tolerate this regimen for over a deca...
How would you treat a patient with borderline resectable pancreatic cancer with CT showing no change in tumor size after 4 cycles of neoadjuvant FOLFIRINOX?
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How do you treat stage I head of pancreas adenocarcinoma in an older patient who is not a candidate for chemotherapy or surgery?
The question of how to manage an elderly patient who is not a candidate for chemotherapy or surgery is a really important one. I would argue that this question is not unique to an elderly patient but should be asked for ANY patient who cannot receive systemic therapy. We are fortunately living in a ...
For metastatic pancreatic cancer, is there a role for maintenance chemotherapy if patient has stable disease at the end of 12 cycles of dose reduced modified FOLFIRINOX?
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