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背景与目的:目前临床应用的抗表皮生长因子受体(epidermal growth factor receptor,EGFR)的单克隆抗体易产生人抗鼠抗体反应,影响治疗效果。本研究评估人源化的抗EGFR单克隆抗体h-R3联合放疗对局部晚期鼻咽癌的近、远期疗效及毒性反应。方法:将免疫组化证实有EGFR中、强度表达的Ⅲ～Ⅳb期(UICC1997)鼻咽癌初诊患者随机分为单纯放疗组(单放组)和放疗联合h-R3组(联合组),两组的放疗剂量和技术基本相同,联合组在放疗期间每周一次静脉滴注h-R3100mg。用WHO标准评价两组的近期疗效,用Kaplan-Meier法估计两组的生存率。结果:本研究共纳入35例,单放组和联合组分别为17例和18例,其中联合组有1例于治疗中途退组。联合组于治疗结束时、治疗后5周及治疗后17周时的总CR率分别为72.2%、83.3%和83.3%,而单放组分别为35.3%、41.2%和47.1%(P<0.05)。中位随访时间31.9个月(4.2～40.7个月),单放组的3年局部区域控制率、无远处转移生存率分别为和总生存率93.8%、100%和88.2%,联合组分别为100%、88.2%和94.4%,两组间的差异无统计学意义(P>0.05)。联合组除1例出现Ⅱ级呕吐外,均无任何药物不良反应发生,两组的急性放射反应差异也无统计学意义(P>0.05)。结论:h-R3是一种安全性良好的药物,有助于增强局部晚期鼻咽癌的放射灭瘤效应,但对远期疗效似乎无明显影响。
BACKGROUND & OBJECTIVE: Currently, the monoclonal antibodies against epidermal growth factor receptor (EGFR) are prone to produce human anti-mouse antibody responses and affect the therapeutic effect. This study evaluated the short-term and long-term efficacy and toxicity of humanized anti-EGFR monoclonal antibody h-R3 in combination with radiotherapy for locally advanced nasopharyngeal carcinoma. Methods: The newly diagnosed nasopharyngeal carcinoma of stage Ⅲ ~ Ⅳb (UICC1997) with EGFR and EGFR expression were randomly divided into radiotherapy group (radiotherapy alone group) and radiotherapy combined with h-R3 group (combination group) Group radiotherapy dose and technology are basically the same, the combined group during the radiotherapy weekly intravenous h-R3100mg. The WHO curative effect was evaluated in both groups, and Kaplan-Meier method was used to estimate the survival rate of the two groups. Results: A total of 35 cases were enrolled in this study. There were 17 cases in the radiotherapy group and 18 cases in the radiotherapy group. One of them in the combination group was retreated in the middle of treatment. The total CR rates in the combined group at the end of treatment, 5 weeks after treatment and 17 weeks after treatment were 72.2%, 83.3% and 83.3%, respectively, compared with 35.3%, 41.2% and 47.1%, respectively ). The median follow-up time was 31.9 months (ranged from 4.2 to 40.7 months). The three-year local control rate and no-distant-metastasis survival rate were 93.8%, 100% and 88.2% respectively in the single group and in the combined group 100%, 88.2% and 94.4% respectively. There was no significant difference between the two groups (P> 0.05). There was no adverse drug reaction in the combined group except one case of grade 2 vomiting. There was no significant difference in acute radiation response between the two groups (P> 0.05). Conclusion: h-R3 is a safe drug, which can help to enhance the radiation off tumor effect in locally advanced nasopharyngeal carcinoma. However, h-R3 seems to have no obvious effect on long-term efficacy.