奈达铂联合顺铂治疗晚期食管癌多中心临床研究  

Mulcenters clinical trial on the treatment of advanced esophageal carcinoma with combination of nedaplatin and cisplatin

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

机构地区：[1]东南大学附属中大医院,江苏南京210009 [2]常州市肿瘤医院,江苏常州213001 [3]东南大学医学院附属徐州医院,江苏徐州221009 [4]东南大学医学院附属盐城医院,江苏盐城224001 [5]东南大学医学院附属马鞍山医院,安徽马鞍山243000 [6]东南大学医学院附属扬州医院,江苏扬州225001 [7]泰州市第一人民医院,江苏泰州225300

出　　处：《东南大学学报（医学版）》2008年第2期113-115,共3页Journal of Southeast University(Medical Science Edition)

基　　金：2006年度江苏省卫生厅临床药学科研课题资助项目(No.P200606)

摘　　要：目的：探索减量的奈达铂（NDP）联合小剂量顺铂（PDD）及5-氟尿嘧啶（5-FU）持续静脉点滴治疗中晚期食管癌的疗效及毒性反应。方法：非手术、放疗适应证，Ⅲ、Ⅳ期及复发食管癌患者，NDP25mg·m^-2、PDD15mg·m^-2，静脉点滴，第1、8天；5-FU 300mg·m^-2·d^-1，24h持续静脉点滴，第1～5天和第8～12天，与5-FU同步应用叶酸片20mg·次^-1，3次·d^-1口服，21 d为1个周期，2个周期结束后评价疗效。疗程内6个治疗周期或出现不可耐受毒性为止。结果：治疗周期中位值为5。可评价49例，完全缓解（CR）11例，部分缓解（PR）19例，有效（CR＋PR）率61．2％（30／49），中位缓解期5．5个月。Ⅲ、Ⅳ度副反应发生率：恶心呕吐18．37％（9／49），中性粒细胞减少16．33％（8／49），血小板计数减少12．24％（6／49）。结论：减量NDP（减少幅度37．5％）联合小剂量PDD、5-FU／叶酸治疗晚期食管癌疗效确切，安全性较好。Objective To explore the safety and efficacy of the combination of moderate-dose nedaplatin （ NDP）, low-dose cisplatin（PDD） plus continuous infusion （CIV）of 5-FU in advanced esophageal carcinoma. Methods To be eligible for study entry, all patients were the stage Ⅲ, Ⅳ or recurrent esophageal cancer, and were no indicated for operative or radiotherapy. Patients were to receive NDP 25 mg·m^-2 ,i. v. ,on days 1,8 ;PDD 15 mg·m^-2,i. v. ,on days 1,8 ; 5-FU 300 mg·m^-2·d^-1 ,24 h CIV on days 1 -5,8 - 12 .Folic acid tablet 60 mg·d^-1 were used following simultaneous use of 5-FU . Repeated on day 22（ one cycle）. The effect was evaluated after two cycles. Patients were allowed a maximum of six cycles, and patients considered to have intolerable toxicity were withdrawn from study immediately. Results 49 eligible patients were enrolled onto this study and all could be assessable for toxicity, response to chemotherapy. The median number of courses was 5. The number of complete response（CR） was 11 of 49 ; partial response （PR） was 19 of 49 , and the response rate （CR ＋ PR）was 61.2% （30/49）. The median remission time was 5.5 months. The main toxicities （ grade Ⅲ, Ⅳ ） consisted in nausea and vomiting 18.37% （ 9/49 ）, leucopenia 16.33% （ 8/49 ） and thrombocytopenia 12. 24% （6/49）. Conclusion The regimen combining moderate-dose NDP, low-dose PDD plus CIV of 5-FU was active against advanced esophageal carcinoma and secure.

关 键 词：奈达铂 顺铂 化学治疗 晚期食管癌 氟尿嘧啶 

分 类 号：R735.1[医药卫生—肿瘤] R453.9[医药卫生—临床医学]