Pancreatic cancer: adjuvant FOLFIRINOX tops gemcitabine for DFS, OS

  • New Engl J Med

  • de Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Adjuvant therapy with a modified version of FOLFIRINOX yielded significantly longer DFS and OS vs gemcitabine among patients with resected pancreatic cancer and no evidence of metastasis.
  • Benefit came at a cost of increased toxicity.

Why this matters

  • Modified-FOLFIRINOX may become a new therapy option for resected pancreatic cancer.

Study design

  • Multicenter, randomized, phase 3 trial (n=493) of gemcitabine (1000 mg/square meter of body-surface area) or modified-FOLFIRINOX (oxaliplatin [85 mg/square meter], irinotecan [180 mg/square meter], leucovorin [400 mg/square meter], and fluorouracil [2400 mg/square meter]) over 24 weeks.
  • DFS, the primary outcome, defined as absence of cancer-related event, second cancer, or death from any cause.
  • Funding: R&D Unicancer; others.

Key results

  • Median follow-up, 33.6 months.
  • 3-year DFS was higher with modified FOLFIRINOX vs gemcitabine (39.7% vs 21.4%).
    • Median DFS was 42% longer (21.6 months [95% CI, 17.7-27.6] vs 12.8 months [95% CI, 11.7-15.2]).
    • Stratified HR, 0.58 (P<.001>
  • 3-year OS was higher with modified FOLFIRINOX vs gemcitabine (63.4% vs 48.6%).
    • Median OS was 36% longer (54.4 months [95% CI, 41.8-not reached] vs 35.0 months [95% CI, 28.7-43.9]).
    • Stratified HR, 0.64 (P=.003).
  • More grade 3/4 adverse events with modified FOLFIRINOX (75.9% vs 52.9%).

Limitations

  • None identified.