恩度联合多西紫杉醇和顺铂一线治疗晚期食管鳞癌的疗效  

Efficacy of YH-16/DOC/DDP Combination as First-line Regimen for Advanced Esophageal Squamous Cell Carcinoma

作　　者：刘莺[1] 刘文静[1] 王居峰[1] 樊青霞[2] 

机构地区：[1]河南省肿瘤医院内科,郑州450003 [2]郑州大学第一附属医院肿瘤科

出　　处：《肿瘤防治研究》2010年第12期1426-1429,共4页Cancer Research on Prevention and Treatment

摘　　要：目的观察恩度(YH-16)联合多西紫杉醇(DOC)和顺铂(DDP)一线治疗晚期食管鳞癌的疗效及不良反应。方法 27例经组织学证实的晚期食管鳞状细胞癌患者,其中16例接受DOC/DDP方案化疗,11例接受YH-16/DOC/DDP方案化疗。DOC/DDP组:DOC60mg/m2d11小时内静脉输注,DDP30mg/m2d1～32小时静脉输注,21天为一周期;YH-16/DOC/DDP组:DOC/DDP用法同上,YH-167.5mg/m2d1～143～4小时静脉输注,21天为一周期。每化疗2周期后按RECIST标准评价疗效,每1周期后根据CTCAE3.0进行不良反应分级。结果 DOC/DDP组,PR6例(37.5%),总有效率37.5%(CR+PR);中位至疾病进展时间(TTP)142天,中位生存时间(OS)310.5天。YH-16/DOC/DDP组CR1例(9%),PR4例(36.4%),总有效率45.4%(CR+PR);中位至疾病进展时间(TTP)210天,中位生存时间(OS)371天。两组比较TTP及OS差异均无统计学意义。DOC/DDP组和YH-16/DOC/DDP组3～4级血液系统不良反应包括:白细胞减少(44%vs.45%),中性粒细胞减少(38%vs.27%),中性粒细胞减少性发热(6%vs.9%);非血液系统不良反应主要为1～2级的恶心呕吐,其发生率分别为50%和45%。无治疗相关性死亡。结论恩度联合多西紫杉醇和顺铂一线治疗晚期食管鳞癌不延长TTP及OS。Objective To evaluate the efficacy and safety of combination therapy with YH-16,Docetaxel and Cisplatin in advanced esophageal squamous cell carcinoma as a first-line regimen.Methods Twenty-seven patients with histopathologically verified squamous cell carcinoma of the esophagus,with 16 patients receiving DOC/DDP combination chemotherapy and the other 11 patients receiving YH-16/DOC/DDP combination chemotherapy.In the DOC/DDP group patients received DOC 60mg/m2 1h infusion on day 1,DDP 30mg/m2 from day 1 to 3 2h infusion; YH-16/DOC/DDP group received DOC 60mg/m2 1h infusion on day 1,DDP 30mg/m2 from day 1 to day 3 2h infusion; YH-16 7.5 mg/m2 from day 1 to day 14 during 3~4h infusion.Treatment cycles were repeated every 3 weeks.Efficacy was evaluated every 2 circles according to patients RECIST standard,toxicities were assessed based on CTCAE3.0 after each circle.Results In DOC/DDP group,6 patients partial remission （PR）（37.5%）,the overall response rate was 37.5%（CR＋PR）.The median time to disease progress（TTP） was 142 days and median overall survival time（OS） was 310.5 days; while in YH-16/DOC/DDP group one patient was observed complete remission CR（9%）,4 patients partial remission （PR）（36.4%）,the overall response rate was 45.4%; The median time to disease progress（TTP） was 210days,and median overall survival time（OS） was 371 days.TTP and OS did not differ significantly between the two regimens.In DOC/DDP group and YH-16/DOC/DDP group there were grade 3~4 hematological toxicity：leucopenia（44% vs.45%）,neutropenia （38% vs.27%） and febrile neutropenia （6% vs.9%）.Nohematological toxicity consisted mainly of grade 1~2 nausea/vomiting（50% vs.45%）.Furthermore,no treatment-related deaths were observed.Conclusion YH-16/DOC/DDP combination as a first-line regimen for advanced esophageal squamous cell carcinoma did not improve TTP and OS.

关 键 词：恩度 多西紫杉醇 顺铂 食管鳞癌 一线治疗 

分 类 号：R730.53[医药卫生—肿瘤] R735.1[医药卫生—临床医学]