Background: In recent years, a new combination chemotherapeutic regimen comprising docetaxel, cisplatin, and 5-fluorouracil (DCF) has received much attention in the treatment of esophageal cancer. But very few reports have described the use of a combination of docetaxel, nedaplatin, and 5-fluorouracil (DNF) for esophageal cancer. Therefore, we perfomed the first phase-I trial of DNF therapy for advanced esophageal cancer in which we determined the recommended dose of DNF therapy. We then performed a prospective multi-institutional phase-II clinical trial of a DNF regimen in patients with unresectable esophageal cancer. Our aim was to determine the efficacy and feasibility of this DNF protocol.
Methods: Thirty-four patients with unresectable esophageal cancer were enrolled and received DNF therapy. The DNF regimen was repeated every 4 weeks for up to 8 weeks, based on the following recommended doses: docetaxel, 60 mg/m2 (day 1); nedaplatin, 70 mg/m2 (day 1); and 5-fluorouracil 700 mg/m2 (days 1-5). The primary endpoint was the response rate. The secondary endpoints were overall survival and chemotherapy toxicities.
Results: The complete response rate and response rate were 5.9% and 47.1%, respectively. The 2-year overall survival rate and progression-free survival rate were 44.3% and 27.3%, respectively. The median survival time was 594 days. The median progression-free time was 277 days. No treatment-related deaths occurred. Thirty patients (30/34) with grade 3, 4 neutropenia improved relatively quickly with administration of granulocyte colony-stimulating factor.
Conclusions: DNF combination chemotherapy is a useful regimen with relatively minor adverse events and may serve as an effective protocol in patients with unresectable esophageal cancer.