Mulcenters clinical trial on the treatment of advanced esophageal carcinoma with combination of nedaplatin and cisplatin

Objective To explore the safety and efficacy of the combination of moderate-dose nedaplatin(NDP),low-dose cisplatin(PDD) plus continuous infusion(CIV)of 5-FU in advanced esophageal carcinoma.Methods To be eligible for study entry,all patients were the stageⅢ,Ⅳor recurrent esophageal cancer,and were no indicated for operative or radiotherapy.Patients were to receive NDP 25 mg·m-2,i.v.,on days 1,8;PDD 15 mg·m-2,i.v.,on days 1,8;5-FU 300 mg·m-2·d-1,24 h CIV on days 1-5,8-12.Folic acid tablet 60 mg·d-1 were used following simultaneous use of 5-FU.Repeated on day 22(one cycle).The effect was evaluated after two cycles.Patients were allowed a maximum of six cycles,and patients considered to have intolerable toxicity were withdrawn from study immediately.Results 49 eligible patients were enrolled onto this study and all could be assessable for toxicity,response to chemotherapy.The median number of courses was 5.The number of complete response(CR) was 11 of 49;partial response(PR) was 19 of 49,and the response rate(CR+PR)was 61.2%(30/49).The median remission time was 5.5 months.The main toxicities(grade Ⅲ,Ⅳ)consisted in nausea and vomiting 18.37%(9/49),leucopenia 16.33%(8/49)and thrombocytopenia 12.24%(6/49).Conclusion The regimen combining moderate-dose NDP,low-dose PDD plus CIV of 5-FU was active against advanced esophageal carcinoma and secure.