Phase I/II study of docetaxel, cisplatin, and 5-fluorouracil combination chemoradiotherapy in patients with advanced esophageal cancer.

Purpose: This phase I/II study was aimed to determine the recommended dose (RD) of docetaxel, cisplatin, and 5-fluorouracil as combination chemoradiotherapy (DCF-RT) for patients with esophageal cancer and to evaluate the efficacy and safety of this protocol. Methods: Fourteen patients with esophageal cancer enrolled in this dose escalation study to determine the RD for a phase III trial. Efficacy and toxicity in DCF-RT of RD were evaluated in 37 patients with esophageal cancer. Results: The RD for DCF-RT for esophageal cancer in the present study was 50 mg/m docetaxel plus 60 mg/m cisplatin on day 1 and day 29 plus 600 mg/m 5-FU on days 1-4 and days 29-32 and concurrent radiation of 60 Gy/30 fractions/6 weeks. The main toxicities were myelotoxicity and radiation esophagitis. In this phase I/II study, we could have safety and feasibility by RD, because there was low mortality and most toxicities were manageable level. The complete response (CR) rate and response rate were 54.1 and 83.8 %, respectively, in the phase II study. In patients with a classification of clinical T4, the CR rate and response rate were 47.6 and 85.7 %, respectively. The 2-year overall survival rate, 2-year progression-free survival rate, and median survival time (MST) were 52.9, 50.0 %, and 24.7 months, respectively. In patients with clinical T4 classification, the 2-year overall survival rate, 2-year progression-free survival rate, and MST were 43.5, 44.9 %, and 21.6 months respectively. Conclusions: DCF-RT keeps safety and feasibility by management of myelotoxicity adequately in RD. This protocol might produce a high CR rate and favorable prognosis compared with standard chemoradiotherapy for advanced esophageal cancer. [ABSTRACT FROM AUTHOR]