"FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer". The New England Journal of Medicine. 2011. 364:1817-1825. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In patients with metastatic pancreatic cancer and good performance status, how does FOLFIRINOX compare with gemcitabine in terms of efficacy and safety?
FOLFIRINOX compared with gemcitabine significantly prolongs survival in patients with metastatic pancreatic cancer who have good performance status, though with increased toxicity.
FOLFIRINOX, a regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin, was associated with a significant improvement in survival over gemcitabine, the standard treatment for advanced pancreatic cancer, in this study. FOLFIRINOX resulted in a higher response rate and improved progression-free survival but exhibited higher toxicity.
As of my knowledge cutoff date in 2023, current oncology guidelines may consider FOLFIRINOX a first-line treatment option for selected patients with metastatic pancreatic cancer and good performance status. However, newer data may have emerged since then.
Multicenter, randomized, phase 2-3 trial
342 patients with metastatic pancreatic adenocarcinoma that had not been previously treated with chemotherapy.
Inclusion Criteria - Age 18 years or older - Histologically and cytologically confirmed, measurable metastatic pancreatic adenocarcinoma - ECOG performance status score of 0 or 1 - Adequate bone marrow, liver function, and renal function
Exclusion Criteria - Age of 76 years or older - Non-adenocarcinoma pancreatic cancers - Prior radiation for measurable lesions - Cerebral metastases - History of another major cancer - Active infection - Chronic diarrhea - Clinically significant cardiac disease - Pregnancy or breast-feeding
Baseline Characteristics - Median age: 61 years - Male: 56% - Metastases: liver (84%), lung (23%) - Performance status 0: 60%
- FOLFIRINOX: oxaliplatin, irinotecan, fluorouracil, leucovorin every 2 weeks - Gemcitabine: weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks
Primary Outcome - Overall survival: 11.1 months with FOLFIRINOX vs 6.8 months with gemcitabine (P<0.001)
- Progression-free survival: 6.4 months with FOLFIRINOX vs 3.3 months with gemcitabine (P<0.001) - Response rate: 31.6% with FOLFIRINOX vs 9.4% with gemcitabine (P<0.001) - Increased toxicity with FOLFIRINOX, including neutropenia and febrile neutropenia
- Increased toxicity associated with FOLFIRINOX may limit its use. - The selection of patients with good performance status may not be representative of the general population with metastatic pancreatic cancer.
Funded by the French Ministry of Health, Amgen, and the French National League against Cancer, with drug donations from Sanofi-Aventis and Pfizer.
Full protocol, including the statistical analysis plan, available at NEJM.org.