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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

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【作者】 李苏宜万里新凌扬袁保兰顾明张丰林李醒亚童建东吴正东刘琳徐建忠汪竹

【Author】 LI Su-yi1,WAN Li-xin2,LING Yang3,YUAN Bao-lan4,GU Ming5,ZHANG Feng-lin6,LI Xing-ya7,TONG Jian-dong8,WU Zheng-dong9,LIU Lin1,XU Jian-zhong3,WANG Zhu8(1.Clinical Oncology Center,ZhongDa Hospital of Southeast University,Nanjing 210009,China;2.Department of Oncology,Central Hospital of Nanyang,Nanyang 473000,China;3.Department of Oncology,Changzhou Cancer Hospital,Changzhou 213000,China;4.Department of Oncology,Xuzhou Hospital of Southeast University,Xuzhou 221000,China;5.Department of Oncology,Yancheng Hospital of Southeast University,Yancheng 224000,China;6.Department of Oncology,Maanshan Hospital of Southeast University,Maanshan 243000,China;7.Department of Oncology,First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;8.Department of Oncology,Yangzhou Hospital of Southeast University,Yangzhou 225000,China;9.Department of Oncology,First Hospital of Taizhou,Taizhou 225300,China)

【机构】 东南大学附属中大医院临床肿瘤中心河南省南阳市中心医院肿瘤科江苏省常州市肿瘤医院肿瘤内科东南大学医学院附属徐州医院肿瘤科东南大学医学院附属盐城医院肿瘤科东南大学医学院附属马鞍山医院肿瘤科郑州大学第一附属医院肿瘤科东南大学医学院附属扬州医院肿瘤科江苏省泰州市第一人民医院肿瘤科东南大学医学院附属扬州医院肿瘤科 南京210009南阳473000常州213000徐州221000盐城224000马鞍山243000郑州450052扬州225000泰州225300南京210009

【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.

【基金】 2006年度江苏省卫生厅临床药学科研课题(编号:P200606)
  • 【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
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