Abstract

Objective To compare the efficacy and safety of domestic-made Paclitaxel liposomes with Paclitaxel in the treatment of NSCLC.Methods 82 patients with advanced NSCLC were prospectively randomized into two groups,experimental group were given Paclitaxel liposome at 135 mg/ m2 each cycle,and control group were given Paclitaxel at 135 mg/ m2.Both groups combined with DDP at 75 mg/ m2 per cycle every three weeks.The efficacy and safety were evaluated after two cycles.Results 82 patients were enrolled into this study.40 and 42 patients were enrolled into the experimental and control respectively.Of 82 cases,81 were eligible for analysis of side effects and overall response rate.The overall response rate was 27.5 % in experimental group and 24.4 % in control group.There was no significant difference between two groups.Though there was no significant difference in hematological toxicity and most of non-hematological toxicity between the two groups,peripheral neuropathy and the toxicity from the mixed solvent of polyethoxylated castor oil and ethanol were significantly lower in experimental group than those in control group.Conclusion Paclitaxel liposome combined with DDP in the treatment of advanced NSCLC can significantly reduce the incidence of peripheral neuritis and serious hypersensitive reactions with the similar response rate as that of Paclitaxel.

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