Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: A randomized, open-label study

摘要: Abstract Introduction This randomized, open-label study compared pemetrexed versus docetaxel as second-line therapy for Chinese patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary endpoint tested non-inferiority of overall survival (OS) on the combined data from these and those in global registration trial. Data current only (Chinese patients) were basis study's secondary objectives. Methods Patients stage IIIB/IV disease randomized (1:1) to receive (500mg/m 2 ; 107 randomized; 106 treated) (75mg/m 104 102 Day 1 each 21-day cycle. Treatment continued until progressive disease, unacceptable toxicity patient/investigator decision. All efficacy safety analyzed at pre-specified completion; supplementary OS analyses performed later, after additional events had been recorded. Results noninferiority was not met, lower CL P >0.025 (efficacy retained=97.9% [95% CLs: 47.1, 141.9]; =0.0276), population (pemetrexed: n =390, docetaxel: =392). Supplementary values 101.3% (95% 57.9, 148.8), =0.0186. For objectives, assessed =107, =104), median 11.7 12.2 months arms, respectively (HR CLs]: 1.14 [0.78, 1.68], =0.492). 11.4 11.5 months, 1.02 [0.74, 1.40], =0.926). Median PFS 2.8 3.1 1.05 [0.75, 1.46], =0.770) ORR 9.6% 4.1% (odds ratio 2.50 [0.76, 8.25], =0.133) docetaxel, respectively. Pemetrexed-treated significantly fewer drug-related grade 3–4 adverse 20.8%, 40.2%; =0.003). Few serious reported 5 patients, 8 patients). Conclusion comparable superior tolerability this supports use single-agent, non-squamous NSCLC patients. ClinicalTrials.gov: NCT00391274.