尼妥珠单抗联合三维适形放疗治疗复发性鼻咽癌的临床研究

目的 观察尼妥珠单抗联合三维适形放疗对复发性鼻咽癌的疗效和不良反应.方法 32例符合入选标准的复发性鼻咽癌患者按照随机的方法分为两组,对照组采用顺铂方案联合三维适形放射治疗,放疗剂量为60～70Gy/6-7W,2Gy/次,5次/W.在放疗期间予顺铂（20 mg/m2d 1-4）同期全身化疗2个疗程,每3周为一疗程.实验组采用尼妥珠单抗联合三维适形放疗,放疗第一天开始用尼妥珠单抗100 mg加生理盐水250 ml静脉滴注,输液时间不少于60分钟,每周1次,共6～7次.结果 16例接受三维适形放疗联合顺铂化疗的复发性鼻咽癌患者治疗结束后的有效率为43.75％,控制率为68.75％; 16例接受尼妥珠单抗联合三维适形放疗的复发性鼻咽癌患者治疗结束后的有效率和控制率分别为50％和75％,两组间差异无统计学意义.相关的不良反应中,尼妥珠单抗组骨髓抑制及消化道反应发生率较低,两组间差异有统计学意义.与尼妥珠单抗相关的不良反应主要是发热（25％）、血压下降（18.75％）、皮疹（18.75％）,以上不良反应均未影响治疗进程.结论 尼妥珠单抗联合三维适形放疗对于复发性鼻咽癌患者有较好的疗效,不良反应的发生率较低,是复发性鼻咽癌有效的治疗手段.

Clinical study of nimotuzumab and three dimensional conformal radiotherapy in the treatment of recurrent nasopharyngeal carcinoma

Objective To investigate efficacy and tolerability of nimotuzumab in combination with three dimensional conformal radiotherapy in recurrent nasopharyngeal carcinoma.Methods 32 cases of recurrent nasopharyngeal carcinoma were randomly divided into control group and experimental group,16 cases in each group.Control group was treated with conventional concomitant fractionated radiation （60-70 Gy in 2 Gy fractions） and 2 cycles of cisplatin 20 mg/m2 （d1-4） every 3 weeks.Nimotuzumab was added at a dose of 100 mg i.v.weekly for 6-7 weeks at the beginning of radiotherapy in experimental group.Results The response rate （RR） and the disease control rate （DCR） of control group were 43.75％ and 68.75％ respectively,while those of experimental group were 50％ and 75％ respectively,without significant differences between two groups.The most common reported adverse events were lymphopenia and gastrointestinal reactions,with significant difference between two groups.The most frequent nimotuzumab-related adverse events were fever （25％）,hypotension （18.75％） and rash （18.75％）,which didn＇ t disturb the therapy.Conclusion Nimotuzumab in combination with three dimensional conformal radiotherapy is well-tolerated and feasible for recurrent nasopharyngeal carcinoma,worthy of clinical application.