Background: This phase II trial assessed the feasibility and safety of induction chemotherapy with cisplatin (25 mg/m(2) d1-5, d29-34)/docetaxel (75 mg/m(2) d1, d29)/5-fluorouracil (5-FU, 750 mg/m(2) d1-5, d 29-34) followed by external beam radiotherapy concurrent with docetaxel (15 mg/m(2) d1,8,15,22) and 5-FU (300 mg/m(2) continuous infusion on the days of radiotherapy).
Patients and methods: Twenty-four patients with locally advanced carcinoma of the esophagus were included. Following chemotherapy and chemoradiation eligible patients underwent esophagectomy. If surgery could not be performed patients received definitive radiation.
Results: Sixteen patients underwent resection. Pathologic complete remission was achieved in 5 of those 16 patients, 13 patients had downstaging of disease. R0 resection was feasible in all 16 patients. Main grade 3 and 4 toxicities were neutropenia in 10 patients, diarrhea in 4 and postoperative morbidity in 9 patients. At a median follow-up of 16.5 months 15 patients are alive; median survival has not yet been reached.
Conclusion: Neoadjuvant treatment with cisplatin/docetaxel/5-fluorouracil followed by chemoradiation with docetaxel/5-fluorouracil is safe, feasible, and effective.