Evaluation of the combination 5-fluorouracil, dacarbazine, and epirubicin in patients with advanced well-differentiated neuroendocrine tumors

Clin Colorectal Cancer. 2010 Oct;9(4):248-54. doi: 10.3816/CCC.2010.n.037.


Introduction: The aim of this study was to retrospectively analyze the efficacy and safety of the combination of 5-fluorouracil (5-FU), dacarbazine, and epirubicin (FDE) in 39 patients with advanced, well-differentiated neuroendocrine tumors (NETs).

Patients and methods: The primary sites of the disease were the pancreas (16 cases), gastrointestinal tract (12 cases), and extradigestive sites (11 cases). Out of these, 54% of the patients were chemotherapy naive and 74% were progressive. The treatment was a combination of 5-FU 500 mg/m²/day, dacarbazine 250 mg/m²/day for 5 days, and epirubicin 50 mg/m² on day 1, administered every 21 days. Tumoral response was assessed with response evaluation criteria in solid tumors.

Results: Partial response was seen in 17 out of the 39 patients (44%) and the median response duration was 12 months. The median progression-free survival and overall survival were 11 and 21 months, respectively. Disease control was achieved in 83% of the 29 patients in progression at the beginning of the treatment. Objective responses were 58%, 25%, and 36%, for pancreatic, gastrointestinal, and extradigestive NETs, respectively. The sole grade 3/4 toxicity was hematologic.

Conclusion: The FDE regimen is effective in advanced well-differentiated NETs and represents an interesting alternative to streptozocin-based regimens as first- or second-line therapy.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Dacarbazine / administration & dosage
  • Drug Administration Schedule
  • Epirubicin / administration & dosage
  • Female
  • Fluorouracil / administration & dosage
  • Gastrointestinal Neoplasms / drug therapy
  • Humans
  • Kaplan-Meier Estimate
  • Lung Neoplasms / drug therapy
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neuroendocrine Tumors / drug therapy*
  • Neuroendocrine Tumors / pathology
  • Pancreatic Neoplasms / drug therapy
  • Retrospective Studies
  • Treatment Outcome


  • Epirubicin
  • Dacarbazine
  • Fluorouracil

Supplementary concepts

  • FDE protocol