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目的 评价血管生成抑制剂沙利度胺联合化疗治疗晚期非小细胞肺癌(NSCLC)的临床疗效及不良反应.方法 66例NSCLC随机分为治疗组和对照组.治疗组采用NP方案+沙利度胺治疗,长春瑞滨25～30 mg/m2,静滴,第1、8天;顺铂70～80 nc,/m2,静滴,第1天;沙利度胺200 mg/d,口服,第1天起连续给药.对照组采用NP方案化疗,剂量、方法与治疗组相同.结果 治疗组和对照组的有效率分别为51.5%和36.4%,差异无统计学意义(P>0.05).治疗组和对照组的中位疾病进展时间(TTP)分别为6.0个月和3.6个月,治疗组的中位TTP显著延长(P=0.0005).治疗组和对照组间毒副反应发生率比较,差异无统计学意义(P>0.05);治疗组患者治疗后生活质量评分较对照组有提高,但差异无统计学意义(P>0.05).结论 沙利度胺与NP方案具有协同作用,联合应用能显著提高晚期NSCLC患者的中位TTP,且不增加治疗后不良反应的发生率.

Objective To evaluate the efficacy, median time to progression (TIP), quality of life and toxicity in the patients with advanced non-small cell lung cancer(NSCLC), treated with thalidomide plus vinorelbine and cisplatin (NP) or NP alone. Methods Sixty six patients with advanced NSCLC were divided randomly into two groups, the trial and control groups. The trial group was treated with vinorelbine 25～30 mg/m2 I.v. On D1 and D8, cisplatin 70～80 mg/m2 I.v. On D1 (NP regimen), and thalidomise 200 nag orally and daily from D1. The control group received vinorelbine and eisplatin as above described. Results Of 66 assessable patients, the overall response rate was 51.5% in the trial group and 36.4% in the control group (P=0.22). The median TIP was 6.0 months for the trial group, and 3.6 months for the control group (P<0.001). The score of quality of life in trial group was higher than that in the control group, but no significant difference was observed between the two groups (P>0.05). There were no significant differences in toxicities between the two groups (P>0.05). Conclusion NP regimen combined with thalidomide can significantly prolong the median time to tumor progression in patients with advanced NSCLC. Thalidomide may have a synergie activity with NP regimen without increased toxicities.