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

作　　者：李苏宜[1] 万里新[2] 凌扬[3] 袁保兰[4] 顾明[5] 张丰林[6] 李醒亚[7] 童建东[8] 吴正东 刘琳[1] 徐建忠[3] 汪竹[8] 

机构地区：[1]东南大学附属中大医院临床肿瘤中心,南京210009 [2]河南省南阳市中心医院肿瘤科,南阳473000 [3]江苏省常州市肿瘤医院肿瘤内科,常州213000 [4]东南大学医学院附属徐州医院肿瘤科,徐州221000 [5]东南大学医学院附属盐城医院肿瘤科,盐城224000 [6]东南大学医学院附属马鞍山医院肿瘤科,马鞍山243000 [7]郑州大学第一附属医院肿瘤科,郑州450052 [8]东南大学医学院附属扬州医院肿瘤科,扬州225000 [9]江苏省泰州市第一人民医院肿瘤科,泰州225300

出　　处：《肿瘤》2008年第5期446-449,共4页Tumor

基　　金：2006年度江苏省卫生厅临床药学科研课题(编号:P200606)

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：NDP25mg／m^2，静脉滴注，PDD15mg／m^2，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：NDP40mg／m^2，静脉滴注，第1～2天。C组：PDD40mg／m^2，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，22d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。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/m^2 , iv） and PDD （ 15 mg/m^2 , iv） on day 1 and day 8 and continuously infused with 5-FU （300 mg/m^2 ） for 24 h on days 1-5 and days 8-12. Group B were given NDP （40 mg/m^2, iv） on days 1-2 and continuously infused with 5-FU （500 mg/m^2, iv） on days 1-5. Group C were administered PDD （40 mg/m^2, iv） on days 1-2 and infused with 5-FU （500 mg/m^2 , 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.

关 键 词：食管癌 药物疗法 联合 奈达铂 氟尿嘧啶 顺铂 

分 类 号：R730.53[医药卫生—肿瘤]