Results of neoadjuvant chemoradiotherapy with docetaxel, cisplatin, and 5-fuluorouracil for advanced esophageal cancer.

Abstract

171 Background: We previously reported a phase I study of neoadjuvant chemoradiotherapy (CRT ) with docetaxel, cisplatin, and 5-fuluorouracil (DCF) for advanced esophageal cancer. After that, we continued to conduct neoadjuvant CRT with DCF as phase II study and here, we report the results of this study including phase I. Methods: We performed neoadjuvant CRT with DCF chemotherapy and concurrent radiation therapy (40Gy including irradiation field) in patients with advanced esophageal squamous cell carcinoma. Dose of chemotherapy were as follows: docetaxel 25mg/m2 (level 1 n=17), or 30mg/m2 (level 2 n=4) on day 1,15,29 and 43 and cisplatin 70mg/m2 on day 1,29 and 5-fuluorouracil on day 1-4 and 29-32. The tumors were resected during weeks 10-13. Results: From Dec 2009 to Aug 2012, 21patients were enrolled and 19 patients underwent thoracic surgery. There were 17 male and four female subjects of ages ranging from 38 to 72 years (median, 61 years). Of these, 6 patients had stage IIIA esophageal cancer and two had stage IIIB esophageal cancer. All the patients had squamous cell carcinoma. Pathological complete response of primary tumor was achieved in 12 patients (63%) and complete pathological response of both primary tumor and lymph node was seen in eight patients (42%). During CRT, the most common grade 3/4 non-hematological toxicity were anorexia (29%) and esophagitis (29%). During CRT, septic shock caused by infection via catheter was observed and re-operation was performed in one patient with reconstructed gastric tube necrosis.One patient developed recurrent gastric tube ulcer in the anastomotic part 4years after esophagectomy. 10 patients are alive more than 5 years and 5-year overall survival is 47.6% and three of them were level II cases. Conclusions: This preoperative CRT regimen using triplets result in favorite prognosis, but treatment plan should be reconsidered because of relative high toxicity. Because high complete response rate of primary tumor were observed and long-term survival has been obtained at a high rate in the case of level II, we planned new phase I/II study of CRT with DCF without preventive irradiation field. Clinical trial information: R000002555.