Background: A Phase II trial was conducted at the University of Michigan to determine the efficacy of a preoperative regimen of concurrent cisplatin, paclitaxel, and radiation for patients with locoregional esophageal carcinoma.
Methods: Sixty-nine patients with esophageal carcinoma were treated with cisplatin 75 mg/m(2) on Day 1, paclitaxel 60 mg/m(2) on Days 1, 8, 15, and 22, and radiation 1.5 Gray (Gy) twice per day on Days 1-5, 8-12, and 15-19, for a total dose of 45 Gy. Transhiatal esophagectomy was performed on approximately Day 50.
Results: The treatment regimen was well tolerated. Only 13% of patients developed Grade 3 or 4 neutropenia and 17% of patients required feeding tubes. Ninety percent of all patients had complete tumor resection at the time of surgery. Nineteen percent of patients achieved a complete histologic response in the resected specimen. The median survival period was 24 months. One-, 2-, and 3-year survival probabilities were 75%, 50%, and 34%, respectively.
Conclusions: This cisplatin-based preoperative regimen, which contained paclitaxel rather than 5-fluorouracil, was well tolerated. The survival data compared favorably with other previously reported combinations. This regimen is a reasonable preoperative approach for patients with localized esophageal carcinoma.
Copyright 2003 American Cancer Society.