Ⅲ期非小细胞肺癌同期减量放化疗与序贯放化疗的临床试验

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

背景与目的 同期放化疗是当前治疗非小细胞肺癌（non-smallcelllungcancer，NSCLC）的方向，但治疗方案多而乱，毒副反应也大于单纯放疗或单纯化疗。本研究的目的是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周期长春瑞滨（减半）＋顺铂（NP）方案化疗，于放疗第一天同期进行。放疗用6、10MVX线常规分割（每天1．8～2．0Gy／次，每周5次），开始0°、180°放疗40Gy／20-22次后改斜野避开脊髓放疗至总量60Gy／30～33次。同期放化疗结束后继续NP（全量）方案巩固化疗3周期，每28天为一个周期。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NP（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和白细胞减少发生率分别为47．5％、65．0％，明显高于B组的25．0％、42．5％（P〈0．05）；A、B组急性放射性肺炎发生率分别为32．5％和20．0％（P〉0．1）。结论 NP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。

Background and objective Concurrent chemotherapy plus radiotherapy is a trend in treatment of non-small cell lung cancer （NSCLC）, but the treatment program is rather complicated and the toxicity is more severe than chemotherapy or radiotherapy alone. The aim of this study is to evaluate the early response and toxicity of concurrent chemoradiotherapy. Methods Eighty unresectable stage Ⅲ A-Ⅲ B NSCLC patients pathologically proved were randomly divided into 2 groups. Group A： patients were treated with concurrent chemotherapy of vinorelhine （12.5 mg/m^2, on days 1.8, 29. 36） and cisplatin （40 mg/m^2, on days 1.8, 29, 36） （NP regimen） plus conventional radiotherapy. Patients were irradiated at 1.8--2.0 Gy/Fx daily, 5 days per week. The total dose was 60 Gy/30-33 Fx. After the radiation, 3 cycles of NP regimen were performed, hut the dose of vinorelhine was 25 mg/m^2. Group B： patients received sequential chemoradiotherapy. At first radiation was performed as same as group A. Then chemotherapy of NP （NVB 25 mg/m^2 , on days 1 and 8, DDP 80 mg/m^2 , on day 1） 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 and leukopenia were 47.5% and 65.0% in group A, and 25.0% and 42.5% in group B respectively （P〈0.05）. The acute radiation pneumonitis rate was 32.5% in group A and 20.0% in group B （P〉0.1）. Conclusion Concurrent chemoradiotherapy is well tolerated in most unresectable stage Ⅲ A-Ⅲ B NSCLC patients. Its early response is better than sequential chemoradiotherapy.