Abstract
Abstract OBJECTIVES: To estimate the response of Chinese medicine “cocktail” LQ in patients with advanced non-small cells lung cancer, a phase II multicenter, double-blind, randomized clinical trial was conducted. Patients with IIIB/IV stage received LQ and natural product control Spirulina. The end points for this study included overall survival (OS), progression free survival (PFS), safety of the regimen, disease control rate (DCR) and other criteria. METHODS: Patients with stage IIIB/IV advanced NSCLC cancer received LQ treatment and Spirulina. Toxicity was assessed. Quality of life was assessed. The primary objective was overall survival. RESULTS: A hundred and twenty patients were enrolled and 80 were treated. Median age was 60 years (range, 42-75). The median overall survival rate in LQ group and Spirulina group is 10.9 months vs 7.4 months respectively (p<0.0001). Median progression survival free survival is 3.84 months vs 1.97 months in LQ and Spirulina group (p<0.01). There is no side effect were found in there. There were 42 patients with stable disease with the disease control rate of 59.15% in LQ treatment group, Compare with Spirulina group, there were only 4 standard disease, for disease control rate of 11.76% (p<0.001). There are no notable toxicities were found in LQ treatment group. CONCLUSIONS: This first-in-human phase II study of Chinese medicine cocktail LQ used as first-line therapy in patients with advanced NSCLC. LQ, a promising new drug, provides a safer and high effective therapy for late-stage lung cancer patients. Citation Format: Lei Zhang, Chengyu Wu. Results from a phase II clinical study in Chinese population: treatment with Chinese medicine cocktail LQ for patients with stage IIIB/IV advanced non-small cell lung cancer. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr CT127.
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