新辅助化疗加同步放化疗治疗局部晚期鼻咽癌的Ⅱ期临床研究

A phase Ⅱ study of neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma

目的:比较新辅助化疗加同步放化疗与单纯同步放化疗治疗局部晚期鼻咽癌的近期疗效和毒副作用。方法:2004年4月～2006年5月,83例Ⅲ～ⅣA期鼻咽癌初治患者采用随机数字表法分为试验组44例,对照组39例。两组患者均行相同的常规分割根治性二维放疗;试验组在放射治疗前接受2个周期新辅助化疗,采用PF方案:顺铂(DDP)80mg/m2,d1,氟尿嘧啶(5-FU)800mg/m2,d1～d5,21天为1周期。新辅助化疗结束后2周,行同步放化疗,对照组仅行同步放化疗。同步化疗方案:DDP 40mg/m2,1次/周,共6次。结果:中位随访期26.7个月,平均随访期(27.6±10.9)个月,两组患者基本特征具有可比性。试验组的口腔黏膜炎发生率高于对照组(P<0.05),其余各项急性毒副反应两组差异均无统计学意义(P>0.05)。试验组与对照组2年局部区域复发率分别为13.2%和19.4%(P=0.946),2年远处转移率分别为15.8%和22.2%(P=0.021),2年生存率分别为92.12%和89.16%(P=0.251)。结论:初步结果表明,国人局部晚期鼻咽癌采用新辅助化疗加同步放化疗急性毒副反应可以耐受,2年远处转移率较单纯同步放化疗降低,2年局部复发率和生存率相似,推荐行大样本的Ⅲ期临床研究以明确新辅助化疗对局部晚期鼻咽癌是否受益。

Objective：To study the efficacy of neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.Methods：From April 2004 to May 2006,83 eligible patients diagnosed as locally advanced nasopharyngeal carcinoma were enrolled in the study.The patients were treated with concurrent chemoradiotherapy（control group） or neoadjuvant chemotherapy followed by concurrent chemoradiotherapy（trial group）.Neoadjuvant chemotherapy regimens consisted of cisplatin（80mg/m^2,d1） and fluorouracil（800mg/m^2,d1-d 5） every 4 weeks for 2 cycles before concurrent hemoradiotherapy.Concurrent chemoradiotherapy regimens consisted of cisplatin（40mg/m^2,d1） weekly during radiotherapy.The toxicity of regimen and the patient response rate were evaluated.Locoregional failure-free survival rate,distant failure-free survival rate and the overall survival rate were compared.Results：The two groups were balanced in the distribution of all prognostic factors,the 2-year locoregional failure-free survival rate was 19.4%for the control group,and 13.2% for the trial group（P=0.946）.The 2-year distant metastasis-free rate was 22.2% for the control group,and 15.8% for the trial group（P=0.021）.The 2-year overall survival rate was 89.16% for the control group,compared with 92.12% for the trial group（χ^2=1.32,P=0.251）.Conclusion：For patients with locally advanced nasopharyngeal carcinoma in China,neoadjuvant chemotherapy followed by concurrent chemoradiotherapy is feasible and the toxicity of regimen is acceptable.A phase Ⅲ study to definitively test this strategy is warranted.