Clinical study of nedaplatin in the treatment of advanced esophageal carcinoma

Objective To observe the efficacy and toxicity of nedaplatin (NDP) for the patients with advanced esophageal carcinoma. Methods 25 chemotherapy-naive patients were enrolled randomly in two groups, 12 cases in treatment group were administrated with NDP combined with 5-FU, 80mg/m~2 of NDP was infused intravenously on day 1 and 500mg/m~2 of 5-FU was infused intravenously on day 1 to 5, while 13 cases in control group were cisplatin (DDP) combined with 5-FU, 40mg of DDP was infused intravenously on day 1 to 3 and 500mg/m~2 of 5-FU was infused intravenously on day 1 to 5. 20 patients failure to DDP were administrated with NDP alone, 100mg/m~2 of NDP was infused intravenously on day 1. The regimens were repeated every 4 weeks and the efficacy was evaluated using WHO standard after 2 cycles of treatment.Results All of the 45 cases were eligible for clinical response evaluation. The response rate (RR) of patients failure to DDP was 25%, the RRs of treatment group and control group were 50% and 46.2%, respectively. The occurrence rate of thrombocytopenia in treatment group were higher than that in control group. The occurrence rate of nausea and vomiting in control group were higher than that in treatment group.Conclusions The RR of NDP in patients with advanced esophageal carcinoma is similar to DDP, and do has efficacy to the patients failure to PDD. Its major side effect is bone suppression.