Phase II Study of Docetaxel, Nedaplatin, and 5-Fluorouracil Combined Chemotherapy for Advanced Esophageal Cancer
We performed a prospective, multi-institutional, phase-II, clinical trial of a docetaxel, nedaplatin, and 5-fluorouracil (DNF) regimen in patients with unresectable esophageal cancer. Our goal was to determine the efficacy and feasibility of this DNF protocol.
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.
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.
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.
KeywordsDocetaxel Esophageal Cancer Acute Kidney Injury CDDP Complete Response Rate
The authors thank Ms. Tomoko Yano, Ms. Ayaka Ishida, Ms. Ishikubo Ayaka, Ms. Yuka Matsui, and Ms. Yukie Saito for their excellent assistance.
This work was supported in part by Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (JSPS) (Grant Numbers 22591450 and 23591857).
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