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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 observe the short-term and long-term effects and adverse reactions of nimotuzumab combined with cisplatin concurrent chemotherapy in the treatment of locally advanced nasopharyngeal carcinoma. Methods: Seventy-two patients with locally advanced nasopharyngeal carcinoma (54 in stage Ⅲ and 18 in stage Ⅳa) admitted to our hospital from January 2010 to August 2011 were randomly divided into high-dose test group, low-dose test group and control group Group, 24 in each group, and all three groups received IMRT (cumulative prescription dose: GTVnx 70 Gy / 32 F, GTVnd 68 Gy / 32 F, CTV1 62 Gy / 32 F, CTV2 56 Gy / 32 F ; The cycle of radiotherapy was 6 weeks). The control group was treated with cisplatin monotherapy (40 mg / m2, iv, d1 ~ d3 every 21 days for 2 cycles) mg / time, intravenous drip, once a week, a total of 6 times) and low-dose test group (100 mg / time, intravenous drip, once a week, a total of 6 times) in the control group based on the treatment of simultaneous nimotonin Bead monoclonal antibody for treatment. The complete response, partial remission, stable disease and disease progression were evaluated in three groups. The adverse reactions were assessed by NCI-CTC. The follow-up time was 5 years. The median follow-up time, overall survival and relapse rate And accumulate the incidence of distant metastases. Results: There was no significant difference between the three groups (P> 0.05); the three groups did not appear to have died of toxic and side effects; the incidence of toxic adverse reactions in the three groups was basically the same (P> 0.05) Myelosuppression, gastrointestinal toxicity, abnormal liver function mainly. After a median follow-up of 5 years, the median follow-up time was (55.4 ± 3.77) months and (53.8 ± 4.12) months in the high-dose test group and the low-dose test group significantly higher than that in the control group (46.5 ± 7.62 months P <0.05). The overall survival rates of the high-dose and low-dose groups were 87.5% and 83.3%, respectively, significantly higher than those of the control group (62.5%, P <0.05). The recurrence rates and cumulative distant metastases (P> 0.05). There was no significant difference in the median follow-up time, overall survival rate, recurrence rate and cumulative distant metastasis between the high-dose and low-dose groups (P> 0.05). Conclusion: Nepalezizumab combined with cisplatin concurrent chemotherapy for the treatment of locally advanced nasopharyngeal carcinoma has obvious short-term curative effect and less toxic side effects, which can significantly improve the overall survival rate of patients with long-term curative effect.