The combination chemotherapy regimen of FOLFIRINOX (consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin) produced a survival advantage in patients with metastatic pancreatic cancer when compared to gemcitabine, concluded a French phase 2-3 study published in the New England Journal of Medicine.

Pancreatic adenocarcinoma, which represented the fourth leading cause of cancer death in the US in 2010, carries a "grim" prognosis of 5 year survival rates of 6% in Europe and the US. Gemcitabine became the reference treatment after a randomized trial showed significant improvements in median overall survival compared with fluorouracil. Data has, however, been lacking on the efficacy and safety of FOLFIRINOX as compared with gemcitabine as first-line therapy in patient s with metastatic pancreatic cancer.

In the current study Thierry Conroy and colleagues from Nancy University (France) randomly assigned 342 patients from 48 French centres with Eastern Cooperative Oncology Group performance status scores of O or 1 (on a scale of O to 5, with higher scores indicating greater severity of illness) 1:1 to receive FILFIRINOX (n=171) or gemcitabine (n=171). The primary efficacy end point was tumour response, and the secondary end point was safety.

Results showed that the median overall survival was 11.1 months (95% CI, 9.0 to 13.1) in the FOLFIRINOX group compared with 6.8 months in the gemcitabine group (HR 0.57, 95% CI, 0.45 t0 0.73; P<0.001). Furthermore the results showed that the median progression free survival was 6.4 months in the FOLFIRINOX groups versus 3.3 months in the gemcitabine group (HR 0.47. 95% CI, 0.37 to 0.59; P<0.001). However, more patients in the FOLFIRINOX group experienced adverse events, with 5.4% experiencing febrile neutropenia.

"Our findings suggest that FOLFIRINOX is a first-line option for patients with metastatic pancreatic cancer who are younger than 76 years and who have a good performance status (ECOG 0 or 1), no cardiac ischemia, and normal or nearly normal bilirubin levels," wrote the authors, adding that the patient-selection criteria in their study had been more rigorous than that in previous studies.

Article: Conroy T, Desseigne F, Ychou M et al. FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer. N Engl J Med 2011; 364:1817-25.