title: A randomized placebo-controlled clinical study ofnab-paclitaxel as second-line chemotherapy for patients with advanced non-small cell lung cancer in China.
abstract: We performed a randomized and placebo-controlled clinical study to investigate whethernab-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 ofnab-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) fornab-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;P<0.001). The median overall survival (OS) was 6.3 months (95% CI: 3.9-8.2 months) fornab-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;P<0.001). Adverse events (AEs) were also observed fornab-paclitaxel.Nab-paclitaxel can improve survival in patients with advanced NSCLC after unsuccessful first-line chemotherapy.
authors.affiliation: Department of Thoracic Surgery, The People's Hospital of Dongyang City, 60 Wuning West Road, Dongyang City, Zhejiang Province 322100, China julyaris244@yeah.net.
authors.forename: Yueming
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Department of Thoracic Surgery, The People's Hospital of Dongyang City, 60 Wuning West Road, Dongyang City, Zhejiang Province 322100, China.
authors.forename: Jiang
authors.initials: J
authors.lastname: Feng
authors.affiliation: Department of Thoracic Surgery, The People's Hospital of Dongyang City, 60 Wuning West Road, Dongyang City, Zhejiang Province 322100, China.
authors.forename: Weiwei
authors.initials: W
authors.lastname: Hu
authors.affiliation: Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai JiaoTong Universty, Shanghai 200030, China.
authors.forename: Qingquan
authors.initials: Q
authors.lastname: Luo
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D015996:Survival Rate
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D017239:Paclitaxel
keywords: NSCLC; OS; PFS; nab-paclitaxel; second-line