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(2) docetaxel plus 60 mg/m(2) cisplatin on day 1 and day 29 plus 600 mg/m(2) 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.