帕尼单抗联合化疗治疗晚期头颈部肿瘤的研究  

Study on the efficacy of combined chemotherapy based on cisplatin and fluorouracil with or without panitumumab in treatment of advanced malignant tumor in head and neck

作　　者：郭兵[1] 

机构地区：[1]上海交通大学医学院附属第三人民医院口腔颌面肿瘤科,上海201900

出　　处：《临床和实验医学杂志》2013年第22期1811-1814,共4页Journal of Clinical and Experimental Medicine

摘　　要：目的探讨帕尼单抗联合顺铂和氟尿嘧啶作为转移性头颈部恶性肿瘤患者一线治疗的临床疗效和不良反应。方法将79例临床确诊的头颈部恶性肿瘤患者随机的分为试验组和对照组，其中试验组40例，对照组39例。两组患者均接受4个周期的静脉注射顺铂（每周期第1天100mg／m^2）和氟尿嘧啶（每周期第1—4天1000mg／m^2）治疗，每个周期持续3周；试验组在此基础上再给予静脉注射帕尼单抗（每周期第1天9mg／kg）。观察两组患者疗效及不良反应。结果40例试验组患者中总有效为16例（40．0％），完全缓解2例（5．0％），部分缓解14例（35．0％），无变化18例（45．0％），进展6例（15．0％）；而39例对照组患者中总有效为11例（28．21％），完全有效2例（5．13％），部分缓解9例（23．08％），与试验组的有效率有统计学差异（P〈0．05）。试验组Ⅲ级及Ⅲ级以上不良反应事件的发生要多于对照组，给予相应的治疗可以控制；无化疗相关死亡病例发生。结论帕尼单抗联合顺铂和氟尿嘧啶对晚期头颈部恶性肿瘤患者具有较好的疗效，并且其不良反应大多数患者可以耐受。Objective To evaluate the efficacy and safety of panitumumab combined with cisplatin and fluorouracil as first - line treatment for patients with metastatic neoplasm in head and neck. Methods A total of 79 patients with advanced head and neck neoplasm were randomly as- signed to experimental group with 40 patients and control group with 39 patients. Patients in both groups received four courses of 3 - weeks of intra- venous application of cisplatin （100 mg/m2 on day 1 of each course） and fluoreuracil （1 000 mg/m2 on days 1 -4 of each course） ; those in ex- perimental group also received intravenous panitumumab （9 mg/kg on day 1 of each course）. This study was performed to evaluate the efficacy and toxicity of combined chemotherapy. Results The overall response rate in 40 patients of experimental group was 40.0%, with complete response in 2 （5.0%）, partial response in 14 （35.0%）, stable response in 18 （45.0%）, and progress of disease in 6 （ 15.0% ）. For patients in control group, 2 （5.13%） of them got complete response, and 9 （23.08%） of them got partial response. The difference between these 2 groups was sta- tistically significant（ P 〈 0.05 ）. Several adverse events with grade 3 or 4 were more frequently seen in panitumumab group than those in control group. All these adverse reactions were clinically manageable and no death related to chemotherapy had been occurred. Conclusion The applica- tion of panitumumab combined with cisplatin and fluorouracil is an effective regimen in treatment of patients with advanced carcinoma in head and neck, and it had an acceptable toxicity profile.

关 键 词：头颈部肿瘤 帕尼单抗 顺铂 氟尿嘧啶 疗效 毒性 

分 类 号：R739.91[医药卫生—肿瘤]