Phase Ⅱ Study of Intensity-Modulated Radiotherapy Combined with 5-Fluorouracil and Nedaplatin Chemotherapy in Recurrent Esophageal Carcinoma after Curative Operation

Objective To analyze the feasibility and safety of postoperative recurrent esophageal carcinoma patients treated by intensity-modulated radiotherapy combined with 5-Fluorouracil(5-Fu) and nedaplatin chemotherapy. Methods Forty-four esophageal carcinoma patients suffered recurrence after their definitive resection in our department from June 2009 to June 2010.Intensity-modulated radiotherapy combined with 5-Fu and nedaplatin chemotherapy was performed in the patients(gross tumor volume,GTV) of IMRT was prescribed to 60 Gy/30f，2.0 Gy/f and 5-Fu and nedaplatin concurrent chemotherapy was used by 5-Fu 750 mg/（m²·d），d1~5，nedaplatin 80 mg/（m²·d），d1 at week 1 and week 4.The primary endpoint was 1-year survival rate and the second endpoint was toxicity related to the treatment. Results The overall response rate (CR+PR) was 86%（38/44）.1- and 2-year overall survival rate was 72.7% and 60%,respectively.1- and 2-year progression-free survival rate was 63.6% and 36.6%,respectively.Univariate analysis outcome showed that only recurrent site was related with prognosis （χ²=22.848，P=0.000）.All the patients undergone this treatment smoothly.Grade Ⅰ,Ⅱ and Ⅲ leukocytopenia was observed in 16% (7/44)，50% (22/44)，and 34% (15/44) patients，respectively.Grade I,and II digestive tract toxicity was observed in 45% (20/44)，55% (24/44) patients，respectively.Grade Ⅰ,and Ⅱ liver/renal toxicity was observed in 77% (34/44)，and 23% (10/44) patients，respectively.Over grade 3 digestive tract and liver/renal toxicity were not found.All the toxicities were gone after corresponding therapy. Conclusion Concurrent chemotherapy with 5-Fu and nedaplatin plus intensity-modulated radiotherapy is an effective and feasible regimen and would be considered as a better option for postoperative recurrent esophageal carcinoma patients,which could be deserved to be applied to phase Ⅲ clinical trial.