Wu Yueming, Feng Jiang, Hu Weiwei, Luo Qingquan
Department of Thoracic Surgery, The People's Hospital of Dongyang City, 60 Wuning West Road, Dongyang City, Zhejiang Province 322100, China
Department of Thoracic Surgery, The People's Hospital of Dongyang City, 60 Wuning West Road, Dongyang City, Zhejiang Province 322100, China.
Biosci Rep. 2017 Jul 27;37(4). doi: 10.1042/BSR20170020. Print 2017 Aug 31.
We performed a randomized and placebo-controlled clinical study to investigate whether -paclitaxel can improve survival in patients with advanced non-small cell lung cancer (NSCLC) after unsuccessful first-line chemotherapy. Patients with stages III to IV advanced NSCLC after first-line platinum-based chemotherapy failure were randomly assigned in a 1:1 ratio to receive second-line treatment of -paclitaxel or placebo. Ninety two eligible patients were enrolled in the study. The median progression-free survival (PFS) was 4.6 months (95% confidence interval (CI): 3.4-6.7 months) for -paclitaxel, compared with 2.0 months (95% CI: 0.9-4.3 months) for placebo, representing a 56% reduction in disease progression (hazard ratio: 0.62; 95% CI: 0.33-0.81; <0.001). The median overall survival (OS) was 6.3 months (95% CI: 3.9-8.2 months) for -paclitaxel, compared with 4.9 months (95% CI: 2.1-5.9 months) for placebo, representing a 22% reduction in disease progression (hazard ratio: 0.71; 95% CI: 0.33-0.85; <0.001). Adverse events (AEs) were also observed for -paclitaxel. -paclitaxel can improve survival in patients with advanced NSCLC after unsuccessful first-line chemotherapy.
我们开展了一项随机、安慰剂对照的临床研究，以调查紫杉醇能否改善一线化疗失败后的晚期非小细胞肺癌（NSCLC）患者的生存率。一线铂类化疗失败后的Ⅲ至Ⅳ期晚期NSCLC患者按1:1比例随机分组，接受紫杉醇或安慰剂的二线治疗。92名符合条件的患者纳入该研究。紫杉醇组中位无进展生存期（PFS）为4.6个月（95%置信区间（CI）：3.4 - 6.7个月），而安慰剂组为2.0个月（95%CI：0.9 - 4.3个月），疾病进展降低了56%（风险比：0.62；95%CI：0.33 - 0.81；<0.001）。紫杉醇组中位总生存期（OS）为6.3个月（95%CI：3.9 - 8.2个月），安慰剂组为4.9个月（95%CI：2.1 - 5.9个月），疾病进展降低了22%（风险比：0.71；95%CI：0.33 - 0.85；<0.001）。紫杉醇也观察到了不良事件。紫杉醇可改善一线化疗失败后的晚期NSCLC患者的生存率。
