调强适形放射治疗与常规放疗联合化疗治疗局部区域晚期鼻咽癌的随机对照临床研究

A randomized clinical study of intensity-modulated radiotherapy vs conventional radiotherapy combined with chemotherapy in treating local/regional advanced nasopharyngeal carcinoma

目的:本研究旨在比较调强适形放射治疗(intensity modulated radiation therapy,IMRT)与常规放疗(radiation therapy,RT)联合化疗(chemotherapy,CT)治疗局部区域晚期鼻咽癌的临床疗效、急性反应和晚期损伤。方法:2005年1月—2007年9月,80例初治鼻咽癌患者(按92福州分期,Ⅲ期50例,ⅣA期30例)随机接受RT+CT(40例)和IMRT+CT(40例)。CT方案为顺铂为主的方案,包括放疗期间同步化疗以及放疗结束后的辅助化疗。按放射反应评分标准(RTOG/EORTC)评价急性和晚期放射损伤。采用Kaplan-Meier法评估1和2年局部区域控制率、无远处转移生存率和总生存率。结果:RT+CT组的1和2年局部区域控制率、无远处转移生存率和总生存率分别为87.5%、90.0%和87.5%以及80.0%、82.5%和80.0%;IMRT+CT组则分别为100.0%、97.5%和97.5%以及97.5%、95.0%和97.5%。2组的2年局部区域控制率和总生存率差异有统计学意义(P<0.05)。全组患者的急性放射损伤多为2～3级,晚期放射损伤多为1～2级。RT+CT组的口咽黏膜急性不良反应发生率较高;放疗后1年,RT+CT组中重度口干发生率为82.5%,而IMRT+CT组仅表现为轻度口干。结论:IMRT联合化疗治疗局部区域晚期鼻咽癌患者可获得较好的局部区域控制率和总生存率,且IMRT可明显减轻放疗引起的口干。

Objective：To investigate the differences in efficacy,survival outcomes,and acute and late toxicities for patients with local/regional advanced nasopharyngeal carcinoma（NPC） treated by intensity-modulated radiation therapy（IMRT） combined with chemotherapy（CT） vs conventional radiation therapy（RT） combined with CT.Methods：Eighty newly diagnosed local/regional advanced NPC patients were randomized to be treated by IMRT combined with CT（IMRT＋CT）（n=40） or RT combined with CT（RT＋CT）（n=40） between January 2005 and September 2007.CT（cisplatin administered） protocol included concurrent CT during radiation therapy and adjuvant CT after radiation therapy.The distributions of clinical stage according to Fuzhou 92 staging system were 50 of Ⅲ stage and 30 of ⅣA stage.The acute and late radiation toxicities were evaluated by toxicity criteria of the Radiation Therapy Oncology Group（RTOG） and the European Organization for Research and Treatment of Cancer（EORTC）.One-and two-year local/regional control rates,distant metastasis-free survivals and overall survivals were analyzed by the Kaplan-Meier method.Results：The one-and two-year local/regional control rates,distant metastasis-free survivals and the overall survivals in RT＋CT group were 87.5%,90.0% and 87.5%,and 80.0%,82.5% and 80.0%,respectively,which in IMRT＋CT group were 100.0%,97.5% and 97.5%,and 97.5%,95.0%and 97.5%,respectively.The two-year local/regional control rate and the overall survival in IMRT＋CT group were higher than those in RT＋CT group（P0.05）.Most patients had grade 2-3 acute radiation toxicities and grade 1-2 late radiation toxicities.The rates of oral and oropharyngeal mucosa toxicities were high in RT＋CT group,and the rate of severe xerostomia was 82.5% one year after radiation therapy;however,the xerostomia severity in IMRT＋CT group was mild.Conclusion：The potential advantages of IMRT＋CT over RT＋CT in treating local/regional advanced NPC patients might occur in local/regional control and overall survival,and the IMRT-induced xerostomia is mild.