Diminished dose nedaplatin combined with low-dose cisplatin as first-line therapy for advanced esophageal carcinoma:a randomized clinical trial

Objective: To investigate the safety and efficacy of the combination of diminished dose of nedaplatin(NDP) and low dose of cisplatin(PDD) for advanced esophageal carcinoma.Methods:The patients who had no indications for surgery or radiotherapy were recruited in our study.They were divided into the three groups randomly.Group A were given NDP(25 mg/m2,iv) and PDD(15 mg/m2,iv) on day 1 and day 8 and continuously infused with 5-FU(300 mg/m2) for 24 h on days 1-5 and days 8-12.Group B were given NDP(40 mg/m2,iv) on days 1-2 and continuously infused with 5-FU(500 mg/m2,iv) on days 1-5.Group C were administered PDD(40 mg/m2,iv) on days 1-2 and infused with 5-FU(500 mg/m2,iv) on days 1-5.All the patients were given folic acid tablet 60 mg/d following infusion of 5-FU.The therapeutic regimens were repeated every 22 days(one cycle).The effect was evaluated after two cycles.Results:The total response ratio(complete response and partial response) and median remission time were 60.00% and 5.5 months for group A,respectively;54.54% and 5.0 months for group B,respectively;41.18% and 3.0 months for group C,respectively.The difference was not significant between group A and group B(P0.05).The clinical efficacy in groups A and B was significantly different compared with group C(P0.05).The main toxicities included leucopenia and thrombocytopenia.The incidence rate of Ⅲ to Ⅳ grade leucopenia was 14.29%,27.27%,and 8.82% in groups A,B,and C,respectively;and that of thrombocytopenia was 11.43%,39.39%,and 5.88%,respectively.The difference was significant(P0.05).Conclusion:Diminished dose of NDP combined with low dose of cisplatin has definite effects on advanced esophageal carcinoma with less hematological toxicity.