长春瑞滨和奥沙利铂方案同步放化疗治疗Ⅲ期非小细胞肺癌随机对照临床观察

A randomized comparative clinical study of concurrent chemoradiotherapy plus adjuvant and neoadjuvant chemotherapy with NO regimen for stage-Ⅲ NSCLC

目的观察长春瑞滨、奥沙利铂方案同步放化疗治疗非手术选择的局部晚期(Ⅲ期)非小细胞肺癌的可行性及患者的耐受性,并比较同步放化疗前后联合诱导化疗或辅助化疗不同化疗时序对疗效及毒副反应的影响。方法49例经病理或细胞学确诊的局部晚期非小细胞肺癌患者随机分为A、B两组。A组24例予长春瑞滨联合奥沙利铂方案诱导化疗2周期后,从第3周期第1天开始施行同步放化疗,放疗期间继续原方案化疗2周期。B组25例于长春瑞滨联合奥沙利铂方案第1周期化疗第1天开始实行放疗,放疗期间化疗2周期,同步放化疗结束后即第3周期开始予原方案巩固2周期。两组化疗方案均采用长春瑞滨联合奥沙利铂方案化疗(长春瑞滨25 mg/m2,第1天及第8天;奥沙利铂130 mg/m2,第1天)。放疗采用6MV X射线,三维适形放疗技术,常规剂量分割,DT40 Gy后缩野,追加剂量至DT60 Gy。结果所有患者均顺利完成治疗。A组有效率62.5%(CR 2例,PR 13例),1,2年生存率分别为62.5%和41.7%;B组有效率64.0%(CR 3例,PR 13例),1,2年生存率分别为64.0%和44.0%,两组间差异无显著性。毒副反应主要是白细胞减少,周围神经感觉异常,恶心、呕吐,放射性食道炎及肺炎。发生率以诱导化疗组高,但差异无显著性,严重毒副反应少。结论长春瑞滨联合奥沙利铂方案同步放化疗治疗局部晚期非小细胞肺癌近期疗效较理想,毒副反应轻,患者能耐受。同步放化疗前后诱导与巩固化疗时序对疗效及毒副反应影响不大。

Objective To evaluate the clinical efficacy and toxicity of concurrent chemoradiotherapy plus adjuvant chemotherapy or neoadjuvant chemotherapy with vinorelbine （NVB） and oxaliplatin （OXA） regimen in treatment of stage-Ⅲ NSCLC. Methods A total of 49 patients with locally advanced unresectable stage-Ⅲ NSCLC were enrolled into this study. All patients were randomly divided into neoadjuvant group （group A ,24 cases） and adjuvant group （group B ,25 cases ）. Group A received concurrent ehemoradiotherapy after two cycles of neoadjuvant chemotherapy and group B received concurrent chemoradiotherapy before two cycles of adjuvant chemotherapy. Both groups were given 6MV-X ray for three-dimensional conformal radiotherapy at routine dose fraction, with a total dose of 60 Gy. The two groups were given two cycles of NVB ＋ OXA （vinorelbine 25 mg/m^2 on the 1st and 8th days,oxaliplatin 130 mg/m^2 on the 1st day）while radiotherapy. Results The overall response rate was 62.5 % in group A versus 64.0% in group B,with no statistically significant difference（ P 〉 0.05 ）. The 1 -and 2-year survival rates in group A were also similar to those in group B （62.5 % and 41.7% vs 60.0% and 44.0% ,P 〉 0.05 ）. The main toxic reactions were leucopenia,peripheral neuritis, nausea/vomiting, radiation esophagitis and pneumonitis. The total incidence of side reactions in group A was higher than that in group B, but without statistical difference between the two groups. Conclusion Concurrent chemoradiotherapy plus neoadjuvant or adjuvant chemotherapy with regimen of vinorelbine/oxaliplatin was effective and safe in the treatment of un-resectable stage- Ⅲ NSCLC. The efficacy and toxicity of the two groups were similar. These treatment methods may be worthy of further clinical investigation.