Phase II Study of Docetaxel, Cisplatin, and 5-Fluorouracil Chemoradiotherapy for Unresectable Esophageal Cancer.

BACKGROUND/AIM: We performed a phase II study of triple-drug combination chemoradiotherapy (DCF-R therapy), in which docetaxel was added to the standard chemoradiotherapy (cisplatin [CDDP]/5-fluorouracil [5-FU]) for unresectable advanced esophageal cancer.

PATIENTS AND METHODS: Sixty-one patients with unresectable advanced esophageal cancer underwent the following DCF-R therapy: intravenous infusion of l60 mg/m2 docetaxel and 60 mg/m2 of CDDP (day 1), and 600 mg/m2 of 5-FU (days 1-5); 2 courses administered within a 4-week interval. Radiotherapy comprised 60 Gy in total.

RESULTS: Response rates were 85.2% for the main lesion, 80.7% for metastasized lymph nodes, and 67.6% for distant organ metastases. Common adverse effects were leukopenia, anemia, and nausea, in 98.4%, 62.3%, and 60.7% of patients, respectively. Treatment completion rate was 90.2% and no treatment-associated deaths occurred. Median survival time was 406 days and 1-, 2-, and 5-year survival rates were 58.6%, 39.1%, and 22.8%, respectively.

CONCLUSION: DCF-R therapy for unresectable advanced esophageal cancer demonstrated a high antitumor effect with sufficient safety.