抗表皮生长因子受体单克隆抗体h—R3联合放疗治疗晚期鼻咽癌的Ⅱ期临床研究  

Multi-center phase Ⅱ clinical trial of humanized anti-epidermal factor receptor monoclonal antibody h-R3 combined with radiotherapy for Iocoregionally advanced nasopharyngeal carcinoma

作　　者：黄晓东[1] 易俊林[1] 高黎[1] 徐国镇[1] 金晶[1] 杨伟志[1] 卢泰祥[2] 吴少雄[2] 吴仁瑞[2] 胡伟汉[2] 谢伟长[2] 韩非[2] 高远红[2] 高剑铭[2] 潘建基[3] 陈传本[3] 朗锦义[4] 李涛[4] 董昱[4] 付玉彬[4] 樊林[4] 李柏森[4] 黎静[5] 王晓怀[5] 陈炳旭[5] 高献书[6] 张萍[6] 吴湘玮[7] 胡炳强[7] 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤研究所肿瘤医院放射治疗科,北京100021 [2]中山大学肿瘤防治中心放疗科 [3]福建省肿瘤医院放疗科 [4]四川省肿瘤医院放疗科 [5]广州军区广州总医院放疗科 [6]河北医科大学附属第四医院放疗科 [7]湖南省肿瘤医院放疗科

出　　处：《中华肿瘤杂志》2007年第3期197-201,共5页Chinese Journal of Oncology

摘　　要：目的 观察h-R3与放疗联合治疗晚期鼻咽癌的疗效和不良反应。方法 采用随机对照设计，共7个治疗中心参加了这项研究。符合入组标准的晚期鼻咽癌患者随机分为单放组和联合治疗组，两组患者均接受单纯根治性放射治疗，总剂量70～76Gy，联合治疗组同时给予h-R3治疗，剂量为100mg／次，静脉滴注，每周给药1次。结果 共137例患者入组，其中单放组67例，联合治疗组70例。联合治疗组治疗结束、治疗后第5周和第17周时的肿瘤完全缓解（CR）率，在全分析集（ITT集）分别为65．63％、87．50％和90．63％，在符合方案集（PP集）分别为67．21％、90．16％和93．44％，均显著高于单放组。联合治疗组治疗后第17周时，在ITT集和PP集的有效率均为100．00％，均显著高于单放组（90．91％和92．31％）。治疗前后两组间Karnofsky评分差异无统计学意义，联合治疗组患者体重恢复情况明显好于单放组。与h-R3相关的主要不良反应是发热（4．28％）、血压下降（2．86％）、恶心（1．43％）、头晕（2．86％）、皮疹（1．43％）。h-R3对血常规和生化指标无显著影响，并且未增加放疗的副作用。结论 h-R3联合放疗可显著提高晚期鼻咽鳞癌患者的疗效，药物不良反应轻微，对治疗晚期鼻咽癌有很高的临床应用价值。Objective To evaluate the efficacy and safty of the humanized anti-epidermal factor receptor monoclonal antibody h-R3 in combination with radiotherapy for locoregionally advanced nasopharyngeal carcinoma. Methods Totally, 137 patients from 7 medical center around China were randomly divided into combined therapy group or control group. There was no difference in Karnofsky performance score between two groups. All patients in both groups received radical conventionally fractionated radiotherapy to the total dose of DT 70-76 Gy. For the combined therapy group, h-R3 was added at a dose of 100 mg i.v. weekly for 8 weeks started at the beginning of radiotherapy. Results Of the 137 eligilbe patients, 70 were in the combined therapy group treated by h-R3 plus radiotherapy and 67 in the control group by radiotherapy alone. The intent-to-treat （1TY） population consisted of 130 patients, while the per-protocol （PP） population was composed of 126 patients. The efficacy was assessed respectively at three point of time： the end of treatment, the 5th- and 17th-week after treatment. The complete response （CR） of the combined therapy group was significantly higher than that of the control group in both ITT and PP （ITr： 65.63%, 87.50%, 90.63% versus 27.27%, 42.42%, 51.52%; PP： 67.21%, 90.16%, 93.44% versus 27.69%, 43.08%, 52.31% ; P 〈0.05, respectively）. The most common h-R3-related adverse reactions were fever（4.3% ）, hypotension（2.9% ）, nausea（ 1.4% ）, dizziness （2.9%） and rash （ 1.4% ）, which could be reversible if treated properly. Radiotherapy combined with 100 nag h-R3 i. v. weekly was tolerable and did not aggravate the side effects of radiation. The quality of life in the combined therapy group was comparable to that in the control group. Conclusion This phase IT multicenter clinical trial shows that h-R3 in combination with radiotherapy is effective and well-tolerated for the treatment of locoregionally advanced nasopharyngeal carcinoma.

关 键 词：鼻咽肿瘤 生物疗法 放射治疗 h-R3 

分 类 号：R686[医药卫生—骨科学]