Ⅲ期非小细胞肺癌术前新辅助化疗的随机对照临床试验

A Randomized Clinical Trial of Preoperative Neoadjuvant Chemotherapy in the Treatment of Stage Ⅲ Non-small Cell Lung Cancer

  • 摘要: 目的:探讨术前新辅助化疗治疗Ⅲ期非小细胞肺癌的可行性和不良反应,同时评价其在病期下调率、提高手术切除率及患者生存率中的作用。方法:从1990年1月~2002年1月,对456例Ⅲ期非小细胞肺癌进行前瞻性随机对照试验,234例被随机分入术前新辅助化疗组(试验组),行术前化疗2个周期,其中47例行Gem+DDP方案,35例NVB+DDP方案,86例MVP方案,66例EP方案化疗。化疗结束后4周手术。另222例被随机分入对照组的患者则先行手术治疗。结果:试验组化疗总有效率为67.95%(159/234),病期下调率为35.04%(82/234)。手术切除率试验组为87.02%(181/208),对照组为83.78%(186/222)。两组手术并发症和手术死亡率无显著性差异(P>0.05)。新辅助化疗组术后1、3、5年生存率分别为76.07%、52.99%和34.18%,对照组分别为69.82%、41.44%和22.97%。试验组术后生存率显著高于对照组(P<0.01)。结论:术前新辅助化疗安全、有效,能降低Ⅲ期非小细胞肺癌的病期,提高手术切除率,改善患者术后长期生存率和生活质量。

     

    Abstract: Objective : To explore the feasibility and toxicity of preoperative neoadjuvant chemotherapy in the treatment of stage Ⅲ NSCLC and to evaluate its effects on tumor downstaging, resection rate and survival rate. Methods : From January 1990 to January 2002, 456 patients were randomly devided into group A (preoperative neoadjuvant chemotherapy group) and group B (control group,without neoadjuvant chemotherapy). Group A had 234 cases and group B had 222 cases. The patients in group A were gave 2 cycles of neoadjuvant chemotherapy, and operations were performed in 4 weeks after finishing the last chemotherapy. All 234 cases were gave intravenous chemotherapy. The regimens included Gem+DDP in 47 cases, NYB+DDP in 35 cases, MVP in 86 cases, and EP in 66 cases. The patients in group B were firstly operated. Results : The tumor response to induction chemotherapy was 67.95% (159/234) in group A. The tumor downstaging was 35.04% (82/234). The resection rate was 87.02% (181/208) in group A, and 83.78% (186/222) in group B. No significant differences of operative complications and mortality were observed between the group A and group B. The 1 -, 3- and 5-year survival rate were 76.07% 、52.99% and 34.18% in group A, and 69.82% 、41.44% and 22.97% in group B respectivelyK The long-term survival rate in group A was remarkably higher than that in group B (P<0.01). conclusion : The preoperative neoadjuvant chemotherapy is safe and effective. It is helpful to decrease the tumor staging, to increase the resection rate of the tumor, and to improve the long-term survival rate and life qualities of patients with stage Ⅲ NSCLC.

     

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