Abstract: Objective To evaluate the efficacy and side effects of elemene injection combined with radiotherapy compared to TP regime（paclitaxel+nedaplatin） combined with radiotherapy in the treatment of esophageal cancer.
MethodsOne hundred and twentyfive patients diagnosed as esophageal cancer from December 2006 to December 2009 were randomly divided into three groups: radiotherapy group（RT group， n=45）， radiotherapy combined with elemene injection group（RT+E group， n=42） and radiotherapy combined with TP regimen group（RT+TP group， n=38）. Conventional radiotherapy and threedimensional conformal radiotherapy were applied for patients， and the protocol was 2.0Gy／f, 5f/week， DT 60-66Gy. Chemotherapy drugs were taken as follow： elemene injection 400mg／d iv d₁-d₂₁， paclitaxel 150mg／m² iv d₁； nedaplatin 50mg／d iv d₁-d₃. The patients of RT+TP group received a course of TP regimen chemotherapy primarily， then started to receive radiotherapy after relevant examinations. The number of white blood cell（WBC） of the patients was detected and the change of WBC was analyzed every week within the first four weeks in the process of radiotherapy. The side effects and shortterm efficacy of each group were evaluated after radiotherapy. The patients were followed up， then we calculated the survival rate of 1-3 year and drew the KaplanMeier survival curve. Results The response rate of RT group, RT+E group and RT+TP group were 84.4％， 90.5％ and 92.1％, respectively. The incidence rates of the radiation esophagitis were 66.7％， 61.9％ and 60.5％, respectively. The incidence rates of the radiation pneumonitis were 24.4％， 31.0％ and 28.9％, respectively. The incidence rate of the myelosuppression in three groups was 100.0%. There were no significant differences in shortterm efficacy and side effects including radiation esophagitis， radiation pneumonitis and myelosuppression， when three groups compared with each other（P＞0.05）. There was significant increase in the change of WBC when RT+E group compared with the other two groups from the first week to the fourth week in the progress of radiotherapy（P＜0.05）. The oneyear survival rates of the RT group, RT+E group and RT+TP group were 60.0％， 73.8％ and 78.9％； two-year survival rates were 40.0％， 54.8％ and 60.5％； three-year survival rates were 28.9％， 33.3％ and 44.7％, respectively. There were no siginificant differences on the survival rates among 3 groups（P＞0.05）. Conclusion The two combination regimens have similar shortterm efficacy and don't increase the side effects of radiotherapy. In the process of radiotherapy， elemene injection has prominent role on the maintainence of WBC level of patients.