尼妥珠单抗联合顺铂同期化疗治疗局部晚期鼻咽癌疗效

Effects and safety of Nimotuzumab and Cisplatin in concurrent chemotherapy of locally advanced nasopharyngeal carcinoma

目的：观察尼妥珠单抗联合顺铂同期化疗治疗局部晚期鼻咽癌的近期、远期疗效以及毒性不良反应。方法：将我院于2010年1月至2011年8月收治的72例局部晚期鼻咽癌患者（Ⅲ期54例,Ⅳa期18例）随机分为高剂量试验组、低剂量试验组和对照组,每组均为24例,三组全程均给予调强放射治疗（累积处方剂量：GTVnx 70 Gy/32 F,GTVnd 68 Gy/32 F,CTV1 62 Gy/32 F,CTV2 56 Gy/32 F;放疗周期为6周）,对照组同时采用顺铂单药化疗（40 mg/m2,静滴,d1~d3,每21 d为一周期,化疗周期为2周期）,高剂量试验组（200 mg/次,静脉滴注,每周一次,共6次）和低剂量试验组（100 mg/次,静脉滴注,每周一次,共6次）在对照组的治疗基础上同期联合尼妥珠单抗进行治疗。以完全缓解、部分缓解、疾病稳定和疾病进展评价3组近期疗效,并采用NCI-CTC对毒性不良反应进行评定;随访时间为5年,比较3组中位随访时间、总生存率、复发率和累积远处转移发生率。结果：3组近期疗效基本相当,未见明显差异（P〉0.05）;3组未出现因毒副反应致死的情况发生;3组的毒性不良反应发生率基本相当（P〉0.05）,均为骨髓抑制、消化道毒性、肝功异常等为主。随访5年,高剂量试验组和低剂量试验组的中位随访时间分别为（55.4±3.77）个月和（53.8±4.12）个月,明显高于对照组的（46.5±7.62）个月（P〈0.05）;高剂量试验组和低剂量试验组的总生存率为87.5%和83.3%明显高于对照组的62.5%（P〈0.05）;3组复发率和累积远处转移发生率无明显差异（P〉0.05）;高剂量试验组和低剂量试验组的中位随访时间、总生存率、复发率和累积远处转移发生率比较差异均无统计学意义（P〉0.05）。结论：尼妥珠单抗联合顺铂同期化疗治疗局部晚期鼻咽癌近期疗效显著,毒副反应较小,可以明显提高患者的总生存率,远期疗效较佳。

Objective：To investigate the short-term and long-term effects and toxicity of Nimotuzumab and cisplatin chemotherapy in the concurrent chemotherapy of locally advanced nasopharyngeal carcinoma （NPC）. Methods： A total of 72 patients with locally advanced NPC （54 cases of stage Ⅲand 18 cases of stage Ⅳ a） , who were hospitalized in our hospital between January 2010 and August 2011, were randomly divided into the high-dose group, low-dose group and control group （ n = 24 each）. All groups were given modulated radiation therapy （Cumulative dose prescription： GTVnx 70 Gy/32 F,GTVnd 68 Gy/32 F,CTV1 62 Gy/32 F,CTV2 56 Gy/32 F ; with a radiotherapy cycle of 6 weeks）. The control group was treated with Cisplatin alone （40 mg/m2, intravenous infusion,d1-d3, one cycle every 21 d,2 cycles of chemotherapy）. The high-dose group （200 mg/ time,intravenous infusion, once a week, a total of 6 times） and low-dose group （100 mg/time, intravenous infusion, once a week,a total of 6 times） were given concurrent chemotherapy with Nimotuzumab on the basis of the treatment in the control group. The short-term effects of the three groups were evaluated with complete remission,partial remission, stable disease and disease progression. National Cancer Institute Common Toxicity Criteria （NCI-CTC） was used to evaluate the toxicity. The length of follow-up was 5 years. The median length of follow-up, overall survival rate, recurrence rate and cumulative incidence of distant metastasis between the three groups were compared. Results： The short-term effects in the three groups were similar, without significant differences （P〈0.05）. There was no mortality of toxic side effects in the three groups,and the incidence of toxicities in the three groups was similar （P〉0.05） ,which were mainly myelosuppression, gastrointestinal toxicity and liver function abnormality. At 5 years after the follow-up, the median length of follow-up in the high-dose and low-dose groups were （55.4±3.77） and （ 53.8 ± 4.12） months, respectively, which was significantly higher than （46.5±7.62） months in the control group; the overall survival rate in the high-dose and low-dose groups were 87.5% and 83.3%,respectively,which was significantly higher than that in the control group （P〈0.05）. There were no significant differences in the recurrence rate and cumulative incidence of distant metastasis between the three groups （P〉0.05）. There were no statistically significant differences in the median length of follow-up, overall survival rate, recurrence rate and cumulative incidence of distant metastasis between the high-dose group and low-dose group （P〉0.05）. Conclusion： The short-term effect of Nimotuzumab and Cisplatin in the treatment of locally advanced NPC is significant and its toxicity is less. It can significantly improve the overall survival rate of patients with better long-term effect.