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.