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目的:评价长疗程尼妥珠单抗(nimotuzumab)联合调强放疗和化疗治疗局部晚期鼻咽癌有效性和安全性。方法:分析从2008年11月至2014年3月在浙江省肿瘤医院39例确诊为Ⅲ-Ⅳ期鼻咽癌患者,其中男性29例,女性10例;Ⅲ期20例,Ⅳa期14例,Ⅳb期5例。患者接受长疗程尼妥珠单抗联合调强放、化疗,尼妥珠单抗200 mg/次,1次/周,所有患者治疗9~18周。观察长疗程尼妥珠单抗联合调强放、化疗的疗效及毒副作用,参考RTOG标准分析患者急、慢性毒副作用;采用Kaplan-Meier方法、Log-rank法检验分析生存情况。结果:所有患者接受9周期以上尼妥珠单抗联合调强放、化疗的治疗后,中位随访时间46月(22~86个月),3年无局部复发生存率(LRFS)、无区域复发生存率(RRFS)、无远处转移生存率(DMFS)、PFS和OS分别为92.1%、89.7%、82.5%、77.6%和86.8%。单因素分析显示临床分期和新辅助化疗周期对生存率重要影响(3年DMFSⅢ、Ⅳ期分别为100.0%和63.2%(P<0.01);3年LRFS 1~2周期、3~4周期分别为75.0%和96.8%(P<0.05)。结论:长疗程尼妥珠单抗联合调强放疗、化疗提高局部晚期鼻咽癌的疗效,并不增加毒、副作用,其远期疗效有待于长期随访结果。
OBJECTIVE: To evaluate the efficacy and safety of long-course nimotuzumab in combination with intensity modulated radiotherapy and chemotherapy in the treatment of locally advanced nasopharyngeal carcinoma. Methods: From November 2008 to March 2014, 39 patients diagnosed as stage Ⅲ-Ⅳ nasopharyngeal carcinoma in Zhejiang Cancer Hospital were enrolled. Among them, 29 were males and 10 were females; 20 were in stage Ⅲ, 14 were in stage Ⅳa, Ⅳ b period in 5 cases. Patients received a long course of nimotuzumab combined with intensity modulated, chemotherapy, nimotuzumab 200 mg / time, 1 / week, all patients treated for 9 to 18 weeks. Observed the long course of nimotuzumab combined with transfer, the curative effect of chemotherapy and toxic side effects, reference RTOG standard analysis of patients with acute and chronic side effects; using Kaplan-Meier method, Log-rank test analysis of survival. RESULTS: All patients received more than 9 cycles of nimotuzumab in combination with intensity modulation. After chemotherapy, the median follow-up time was 46 months (range 22-86 months), 3 years of no local recurrence (LRFS), no regional RRFS, DMFS, PFS and OS were 92.1%, 89.7%, 82.5%, 77.6% and 86.8%, respectively. Univariate analysis showed that the clinical stage and the neoadjuvant chemotherapy cycle had a significant impact on the survival rate (three-year DMFS Ⅲ and Ⅳ stages were 100.0% and 63.2%, respectively; P <0.01); 3-year LRFS 1 to 2 cycles and 3 to 4 cycles were 75.0% and 96.8%, respectively (P <0.05) .Conclusion: Long-course nimotuzumab combined with intensity-modulated radiotherapy and chemotherapy can improve the efficacy of locally advanced nasopharyngeal carcinoma without increasing the toxicity and side effects, and the long-term follow- result.