顺铂不同给药方案同期放化疗治疗鼻咽癌的耐受性研究

Tolerability Study of Concurrent Chemoradiotherapy with Different Dose Regimens of Cisplatin for Nasopharyngeal Carcinoma

目的:评价顺铂不同给药方案同期放化疗治疗鼻咽癌的急性毒副反应及耐受性。方法:2012年3月-10月共160例患者进入本研究,按顺铂不同给药方案随机分为八组(A组、DDP100mg/m^2,d1,q4w;B组、DDP100mg/m^2,分三天用,q4w;C组、DDP80mg/m^2,d1,q4w;D组、DDP80mg/m^2,分三天用,q4w;E组、DDP100mg/m^2,d1,q3w;F组、DDP100mg/m^2,分三天用,q3w;G组、DDP80mg/m^2,d1,q3w;H组、DDP80mg/m^2,分三天用,q3w),均行2周期化疗。各组放疗方案相同,采用常规放疗或调强适形放疗,原发肿瘤和阳性淋巴结总剂量为62~78Gy。结果:主要的急性毒副反应包括:白细胞减少(A组:85%,B组:90%,C组:95%,D组:90%,E组:95%,F组:90%,G组:95%,H组:90%;χ~2=5.312,P=0.622),贫血(A组:95%,B组:85%,C组:90%,D组:85%,E组:100%,F组:95%,G组:80%,H组:100%;χ~2=13.543,P=0.060),呕吐(A组:100%,B组:100%,C组:100%,D组:100%,E组:100%,F组:100%,G组:90%,H组:90%;χ~2=22.534,P=0.068),体重下降(A组:100%,B组:100%,C组:95%,D组:95%,E组:100%,F组:95%,G组:95%,H组:100%;χ~2=9.150,P=0.821),皮肤反应、粘膜反应、口干各组发生率均为100%。各组急性毒副反应发生率无显著差异,所有的并发症经对症支持治疗后均能恢复。结论:顺铂100mg/m^2与80mg/m^2及不同的剂量分割和间隔时间同步化疗治疗鼻咽癌的急性毒副反应发生率无显著差异,患者均能耐受。

Objective： To evaluate the tolerability of concurrent chemoradiotherapy with different dosage of cisplatin for patients with nasopharyngeal carcinoma （NPC）. Methods： A total of 160 patients were randomized into 8 groups with 20 cases per group from Mar. 2012 to Oct. 2012. Fifty-eight patients accepted conventional radiotherapy,and 102 patients re- ceived intensity modulated radiotherapy. Radical radiotherapy with total close of 62 -78Gy was offered to all patients. Pa- tients in group A were given cisplatin 100mg/m2 for 1 day every four weeks, group B cisplatin 100mg/m2 in 3 clays every four weeks, group C eisplatin 80mg/m2 for 1 day every four weeks, group D cisplatin 80mg/m2 in 3 days every four weeks, group E cisplatin 100mg/m2 for 1 day every three weeks,group F cisplatin 100mg/m2 in 3 days every three weeks,group G cisplatin 80mg/m2 for 1 day every three weeks, group H cisplatin 80mg/m2 in 3 days every three weeks, all for two cycles. Results： The acute toxieities consisted of neutropenia（ A：85%, B：90%, C：95%, D：90%, E：95%, F：90%, G：95%, H：90%;X2 =5.312,P=0.622）, anemia（ A：95%, B：85%, C：90%, D：85%, E：100%, F：95%, G：80%,H： 100% ; X2 = 13. 543, P = 0. 060 ）, vomitting （ A ： 100% , B ： 100% , C ： 100% , D ： 100% , E ： 100% , F ： 100% , G ： 90% , H ： 90% ; x2 = 22. 534, P = 0. 068 ）, weight loss （ A ： 100% , B ： 100% , C ：95 %, D ：95 % , E ： 100% , F ： 95 % , G ：95 %, H ： 100% ; X2 =9. 150,P =0. 821 ）. The incidence of dermoreaction,mucositis, and dry mouth in each group were 100%. There were no significant differences on the toxicities and side effects among every group. After active treatments, all complications could be recovered. Concuision： The incidence of acute tox- ic reactions in patients with NPC treated by concurrent che- moradiotherapy is not significantly different between different cisplatin groups （ 100mg/m2 or 80mg/m2 ） and the groups received different administration segmentation and time interval. The adverse reactions arc tolerable.