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联合尼妥珠单抗治疗初治鼻咽癌临床安全性及近期疗效观察
Observation of the safety and the short term efficacy of nimotu-zumab combined with radio-chemotherapy in the treatment for the initial nasopharyngeal cancer
【Author】 He Xia~* Guo Wenjie Jiang Xuesong Wang Feijiang Zhu Xiangzhi Jiang Su Province Tumor Hospital,Department of Radiation(Nan Jing,China 210009 )
【机构】 江苏省肿瘤医院放疗科;
【摘要】 目的:探讨尼妥珠单抗在鼻咽癌综合治疗中的作用,初步观察尼妥珠单抗联合放化疗治疗初治鼻咽癌患者的耐受性及近期疗效。方法:自2009年2月至2010年7月在我院治疗的初治鼻咽癌患者27例。其中男性20例,女性7例。08分期:Ⅱ期1例,Ⅲ期6例,Ⅳ期20例,尼妥珠单抗与放疗或放化疗同时使用,第1周初始剂量为400 mg,以后每周维持剂量为200mg,共6-8周。放疗均实施调强放疗(IMRT),采用同期整合推量照射技术,按两进程分别给GTV1每日2.18 Gy×28次和2.24 Gy×4次,共约70Gy;GTV2每日2.05Gy×28次和2.15Gy×4次,共约66Gy;CTV1每日1.88 Gy×28次和1.84 Gy×4次,共60Gy;CTV2每日1.8 Gy×28次,共50.4Gy.化疗采用TP(紫杉醇+奈达铂)方案15例,DFP(多西他赛+氟尿嘧啶+奈达铂)方案4例,DP方案2例,FAP方案2例,FP方案2例,单药奈达铂周剂量增敏1例,未化疗1例,同步化疗两周期,间隔4周。结果:1例同步放化患者因Ⅲ度肝功能损害,延期2周化疗。1例因使用1次泰欣生出现心动过缓停用,余皆按计划完成全部治疗。治疗期间,出现Ⅲ度以上白细胞减少9例,Ⅲ度以上血小板减少2例,Ⅲ度肝功能损害1例,经对症处理均恢复。几乎所有病例均发生不同程度口腔粘膜反应,仅1例为Ⅳ度反应,经处理均好转。全组完全缓解18例(66.7%),部分缓解9例(33.3%),总有效率100%。中位随访11个月,所有患者随访期内均存活。结论:尼妥珠单抗联合放化疗治疗初治鼻咽癌安全有效,需扩大样本量进一步临床试验研究。
【Abstract】 Objective:To investigate the effect of nimotuzumab combined therapy in the initial treatment of nasopharyngeal carcinoma,to observe the tolerability and the short term efficacy of nimotuzumab combined with radio-chemotherapy in nasophaeyngeal cancer preliminarily.Methods:From February 2009 to July 2010,27 patients(male 20,female7;stageⅡ/Ⅲ/Ⅳ(08 staging:n=1/6/20)) with new diagnosed nasophaeyngeal carcinoma received treatment in our hospital.All received nimotuzumab(initial dose of 400 mg by subsequent weekly doses of nimotuzumab 200 mg for 6-8 weeks) and radiation or chemo-radiation concomitantly.Radiation used intensity modulation radiated therapy (IMRT ),dose of radiation with the technology of concurrent integration,according to the two processes were to GTV1 2.18 Gy daily×28 times and 2.24 Gy×4 times,a total of about 70Gy;GTV2 2.05Gy daily×28 times and 2.15Gy×4 times,a total of about 66Gy;CTV1 1.88 Gy daily×28 times and 1.84 Gy×4 times,a total of 60Gy;CTV2 1.8 Gy daily×28 times,a total of 50.4Gy.chemotherapy with TP(paclitaxel + nedaplatin) program in 15 cases,DFP(docetaxel + FU + nedaplatin ) program in 4 cases,DP program in 2 cases,FAP program in 2 cases,FP program in 2 cases,single nedaplatin sensitization in 1 case,without chemotherapy in 1 case,chemotherapy for two cycles,interval of 4 weeks. Results:1 case of synchronous chemoradiotherapy with liver damage due to gradeⅢextended 2 weeks chemotherapy.1 patient stopped using nimotuzmab in second time due to bradycardia,the rest patients received all the treatment basing on the plan.During treatment,leukopenia of gradeⅢ/aboveⅢ9 cases, thrombocytopenia ofⅢ2 cases,liver dysfunction of gradeⅢ1 case,all recovered after symptomatic treatment.Almost all cases,oral mucositis occurred in varying degrees,only 1 case of GradeⅣ,got better after treatment.The overall complete remission in 18 cases(66.7%),partial remission in 9 cases(33.3%), the overall response rate was 100%.The median follow-up is 11 months,all patients survived during the follow up.Conclusion:Nimotuzumab combined with radiotherapy in the initial treatment of nasopharyngeal carcinoma is safe and effective,need to increase the sample size for further clinical trials.
【Key words】 Nimotuzumab; Nasophaeyngeal neoplasma; Intensity Modulation Radiated Therapy(IMRT); chemotherapy;
- 【会议录名称】 第六届全国鼻咽癌学术大会论文汇编
- 【会议名称】第六届全国鼻咽癌学术大会
- 【会议时间】2010-12-09
- 【会议地点】中国福建福州
- 【分类号】R739.63
- 【主办单位】中华医学会放射肿瘤治疗学分会、中国抗癌协会肿瘤放射治疗专业委员会、中国抗癌协会鼻咽癌专业委员会、中国鼻咽癌临床分期工作委员会