Phase II Study of Docetaxel, Nedaplatin, and 5-Fluorouracil Combined Chemotherapy for Advanced Esophageal Cancer.

Abstract

BACKGROUND:

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.

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/m(2) (day 1); nedaplatin, 70 mg/m(2) (day 1); and 5-fluorouracil, 700 mg/m(2) (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.

• Authors: Tatsuya Miyazaki, Hitoshi Ojima, Minoru Fukuchi, Makoto Sakai, Makoto Sohda, Naritaka Tanaka, Shigemasa Suzuki, Keisuke Ieta, Kana Saito, Akihiko Sano, Takehiko Yokobori, Takanori Inose, Masanobu Nakajima, Hiroyuki Kato, Hiroyuki Kuwano
• Journal: Annals of surgical oncology (Ann Surg Oncol) Vol. 22 Issue 11 Pg. 3653-8 (Oct 2015) ISSN: 1534-4681 [Electronic] United States
• PMID: 25691281 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Organoplatinum Compounds
• Taxoids
• Granulocyte Colony-Stimulating Factor
• Docetaxel
• nedaplatin
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, secondary, therapy)
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, secondary, therapy)
• Chemoradiotherapy
• Disease-Free Survival
• Docetaxel
• Esophageal Neoplasms (drug therapy, pathology, therapy)
• Esophagectomy (adverse effects)
• Female
• Fluorouracil (administration & dosage)
• Granulocyte Colony-Stimulating Factor (therapeutic use)
• Humans
• Lung Neoplasms (secondary, surgery)
• Lymph Node Excision
• Lymphatic Metastasis
• Male
• Middle Aged
• Neutropenia (chemically induced, drug therapy)
• Organoplatinum Compounds (administration & dosage)
• Prospective Studies
• Survival Rate
• Taxoids (administration & dosage)
• Treatment Outcome