同期减量放化疗与序贯放化疗治疗Ⅲ期非小细胞肺癌的临床试验

Clinical trial of concurrent low - dose chemotherapy plus radiation vs sequential chemoradiotherapy for unresectable stage Ⅲ non - small cell lung cancer

目的探讨和比较同期减量放化疗与序贯放化疗治疗不能手术的Ⅲ期NSCLC的毒副反应和近期疗效。方法病理证实为Ⅲa，Ⅲb期（非恶性胸腔积液）不能手术的初治NSCLC患者80例随机分为2组。同期放化疗组（A）：2周期紫杉醇（减半量）＋顺铂（11P）方案化疗，于放疗第一天同期进行。放疗用三维适形放疗，放疗至总量60Gy-70Gy。同期放化疗结束后继续Te（全量）方案巩固化疗3周期。序贯放化疗组（B）：入组后先行放疗，放疗方案同A组，放疗结束后行Te（全量）方案化疗4—5周期。采用WHO近期疗效评价标准和放化疗毒副反应分级标准进行评定。结果A组近期有效率为80．0％，B组为57．5％（x^2=4．71，P〈0．05），A组Ⅲ，Ⅳ度急性放射性食管炎，白细胞减少，恶心呕吐和皮肤反应发生率分别为47．5％，42．5％，52．5％和57．5％明显高于B组的25．0％，17．5％，30．0％和17．5％（P〈0．05）；A，B组Ⅲ，Ⅳ度急性放射性肺炎，脱发发生率分别为32．5％，7．5％和20．0％，27．5％（P〉0．05）。结论TP方案减量同期放化疗治疗不能手术的Ⅲ期NSCLC，近期疗效较序贯放化疗组高，副反应经积极对症治疗可以耐受。

Objective Evaluate the early response and toxicity of concurrent chemoradiotherapy. Methods Eighty unresectable stage Ⅲa- Ⅲb NSCLC patients pathologically proved were randomly divided into 2 groups. Group A ： patients were treated with concurrent chemotherapy of paclitaxe[ （ 100 mg/m^2, on day2. ） and cisplatin （30 mg/m^2, on days 2 -6 ） （TP regimen）plus 3 - dimensional conformal radiotherapy. The total dose was 60 Gy -70 Gy. After the radiation,3 cycles of TP regimen were performed,but the dose of paclitaxel was 200 mg/ m^2. Group B： patients received sequential chemoradiotherapy. First radiation was performed as same as group A. Then chemotherapy of TP（ paclitaxel 200 mg/m^2, on day 2, DDP 30 mg/m^2, on days 2 -6）was followed for 4 -5 cycles. Results The overall response rate in concurrent and sequential groups was 80.0% and 57.5% respectively （ x^2 = 4.71, P 〈 0.05 ）. Incidences of grade Ⅲ- Ⅳ acute radiation esophagitis, leukopenia, nausea/vomiting and skin reaction were 47.5% ,42.5% ,52.5% and 57.5% in group A,and 25.0% ,17.5% ,30.0% and 17.5% in group B respectively（P 〈 0.05 ）. Incidences of grade Ⅲ- Ⅳ acute radiation pneumonitis and lose hair rate was 32.5% ,7.5 % in group A and 20.0% ,27.5% in group B respectively （ P 〉 0. 1 ）. Conclusion Concurrent chemoradiotherapy is weU tolerated in most unresectable stage Ⅲa- Ⅲb NSCLC patients. Its early response is better than sequential chemoradiotherapy.