注射用奈达铂治疗头颈部鳞癌与食管癌及非小细胞肺癌Ⅱ期临床试验研究  

Phase Ⅱ clinical trial of nedaplatin in advanced head and neck squamous cell carcinoma,esophageal cancer, non-small cell lung cancer

作　　者：佟仲生[1] 李淑芬[1] 汪旭[1] 南克俊[2] 秦天洁[2] 黄诚[3] 张春[3] 潘良憙[4] 戴爱娣[4] 曾令源[5] 尹序德[5] 

机构地区：[1]天津医科大学附属肿瘤医院肿瘤内二科,天津300060 [2]西安交通大学附属第一医院肿瘤科,陕西西安710061 [3]福建省肿瘤医院肿瘤内科,福建福州350014 [4]江苏省肿瘤医院肿瘤内科,江苏南京210009 [5]四川省肿瘤医院肿瘤内科,四川成都610041

出　　处：《肿瘤防治杂志》2005年第23期1779-1784,共6页China Journal of Cancer Prevention and Treatment

摘　　要：目的:评价比较以奈达铂(NDP)为主的化疗方案与以顺铂(DDP)为主的化疗方案对头颈部鳞癌、食管癌和非小细胞肺癌(nonsmallcelllungcancer,NSCLC)的疗效及不良反应。方法:患者随机分为两组。试验组:头颈部鳞癌及食管癌,NDP联合5氟尿嘧啶(5FU)和四氢叶酸(CF);NSCLCNDP联合诺维本(NVB);对照组:以DDP替代NDP,两组其他用药均相同。所有患者均接受2个周期以上的化疗。结果:2002年5月～2003年11月共有194例患者入组,其中188例完成试验,6例出组。头颈部鳞癌60例,食管癌60例,NSCLC68例。头颈部鳞癌试验组有效率为46.67%,对照组有效率为46.67%,χ2=0.2820,P=1.0000;食管癌试验组有效率为35.48%,对照组有效率为13.79%,χ2=2.4506,P=0.7470;NSCLC试验组有效率为31.43%,对照组有效率为15.15%,χ2=1.4315,P=0.1553。试验组与对照组的不良反应比较,除恶心、呕吐的发生率差异有统计学意义(χ2=3.4124,P=0.0006),前者明显低于后者外,血常规、腹泻、便秘、乏力等不良反应发生率差异均无统计学意义。结论:以NDP为主的联合化疗方案治疗头颈部鳞癌、食管癌、NSCLC疗效肯定,不良反应中呕吐明显减少,轻中度骨髓抑制,其余不良反应可以耐受。OBJECTIVE： To observe the clinical effect and toxicity of Nedaplatin combining chemotherapy in advanced head and neck squamous cell carcinoma, esophageal cancer, non-small cell lung cancer （NSCLC）. METHODS： This is a multi-center phase 11 clinical trial. The chemnative patients with head and neck squamous cell carcinoma, esophageal cancer were randomized into two groups. The combination trial group was given with Nedapl atin ＋ 5-FU＋ CF regimen, and combination contral group was given with cisplatin ＋ 5-FU＋CF regimen, The chemnative patients with NSCLC were randomized into two groups. The combination trial group was given with Nedaplatin ＋ VDS regimen, and combination eontral group was given with cisplatin ＋ VDS regimen. RESULTS： Of 188 patients, 60 cases were head and neck squamous cell carcinoma, 60 eases were esophageal cancer, 68 cases were NSCLC. It had the same response rate, which were 46. 67% versus 46.67% in the trial and control groups in head and neck sqnamous cell carcinoma, X^2 = 0. 282 0, P = 1. 000 0. Response rate was 35. 48% for the combination trial group, or 13.79% for the combination control group in esophageal eaneer,x^2 =2. 450 6,P=0. 747 0. Response rate was 31.43% for the combination trial group, or 15.15%for the combination contral group in NSCLC, X^2 = 1. 431 5, P=0. 155 3. Nedaplatin had a possibility mild nausea and vomiting, The incidence rate of neutrpenia and anemia was similar in the two groups. CONCLUSIONS, Nedaplatin is an effective platinum drug in this clinical trial and has good clinical tolerance, and further evalua tion of these treatment regimens is recommended in such patients.

关 键 词：头颈部肿瘤/药物疗法 食管肿瘤j药物疗法 癌 非小细胞肺/药物疗法 临床试验 Ⅱ期 有机铂化合物/治疗应用 

分 类 号：R739.91[医药卫生—肿瘤]