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减量奈达铂联合顺铂一线治疗晚期食管癌
Diminished dose nedaplatin combined with low-dose cisplatin as first-line therapy for advanced esophageal carcinoma:a randomized clinical trial
【摘要】 目的:观察减量奈达铂(nedaplatin,NDP)加顺铂(cisplatin,PDD)治疗食管癌的疗效及不良反应。方法:不适合手术、放疗患者,随机分组。A组:NDP 25mg/m2,静脉滴注,PDD 15 mg/m2,静脉滴注,第1、8天;5-氟尿嘧啶(5-FU)300mg·m-2·d-1,24h持续静脉滴注,第1~5天、第8~12天。B组:NDP 40mg/m2,静脉滴注,第1~2天。C组:PDD 40mg/m2,静脉滴注,第1~2天。后2组5-FU500mg·m-2·d-1,静脉滴注,第1~5天。3组方案均与5-FU同步口服叶酸,22 d重复。结果:A组有效率(完全缓解+部分缓解)和中位缓解时间为60.00%和5.5个月,B组为54.54%和5.0个月,C组为41.18%和3.0个月。A、B组间差异无统计学意义(P>0.05),A、C组间和B、C组间差异均有统计学意义(P<0.05)。Ⅲ、Ⅳ度骨髓抑制发生率方面,A、B和C组的粒细胞缺乏达14.29%、27.27%和8.82%,血小板减少达11.43%、39.39%和5.88%,差异均有统计学意义(P<0.05)。结论:减量NDP联合小剂量DDP治疗晚期食管癌疗效确切,血液学不良反应明显减缓。
【Abstract】 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(P>0.05).The clinical efficacy in groups A and B was significantly different compared with group C(P<0.05).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(P<0.05).Conclusion:Diminished dose of NDP combined with low dose of cisplatin has definite effects on advanced esophageal carcinoma with less hematological toxicity.
【Key words】 Esophageal neoplasms; Drug therapy,combination; Nedaplatin; Fluorouracil; Cisplatin;
- 【文献出处】 肿瘤 ,Tumor , 编辑部邮箱 ,2008年05期
- 【分类号】R735.1
- 【被引频次】11
- 【下载频次】119