Gu Ai-qin, Han Bao-hui, Zhang Xue-yan, Shen Jie, Qi Da-jiang, Xiong Li-wen, Xin Yu, Song Yi-yi
Department of Pneumology, Shanghai Chest Hospital of Jiaotong Uniyersity, Shanghai 200030, China.
Zhonghua Zhong Liu Za Zhi. 2009 Apr;31(4):298-301.
To evaluate the efficacy, median time to progression (TTP), 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.
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 approximately 30 mg/m(2) i.v. on D1 and D8, cisplatin 70 approximately 80 mg/m(2) i.v. on D1 (NP regimen), and thalidomide 200 mg orally and daily from D1. The control group received vinorelbine and cisplatin as above described.
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 TTP 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).
NP regimen combined with thalidomide can significantly prolong the median time to tumor progression in patients with advanced NSCLC. Thalidomide may have a synergic activity with NP regimen without increased toxicities.
评估沙利度胺联合长春瑞滨和顺铂（NP方案）或单纯NP方案治疗晚期非小细胞肺癌（NSCLC）患者的疗效、疾病进展中位时间（TTP）、生活质量和毒性。
66例晚期NSCLC患者随机分为两组，即试验组和对照组。试验组在第1天和第8天静脉注射长春瑞滨25～30mg/m²，第1天静脉注射顺铂70～80mg/m²（NP方案），并从第1天起每日口服沙利度胺200mg。对照组接受上述长春瑞滨和顺铂治疗。
在66例可评估患者中，试验组的总缓解率为51.5%，对照组为36.4%（P = 0.22）。试验组的疾病进展中位时间为6.0个月，对照组为3.6个月（P < 0.001）。试验组的生活质量评分高于对照组，但两组间无显著差异（P > 0.05）。两组毒性无显著差异（P > 0.05）。
NP方案联合沙利度胺可显著延长晚期NSCLC患者的肿瘤进展中位时间。沙利度胺可能与NP方案具有协同活性且不增加毒性。
