Abstract: Objective: To conduct a randomized comparative trial of pharmacokinetics, efficacy and toxicity profile treatment with 1 200 mg/m² gemcitabine using standard 30-min infusion or fixed dose rate (FDR) infusion [10 mg/(m²·min)] on days 1 and 8 plus carboplatin AUC (area under curve) 5 on day 1 in Chinese non-small-cell cancer patients. Twelve patients were enrolled in this study. Methods: Plasma gemcitabine concentrations were measured by ion-pair reversed phase high performance liquid chromatography. Antitumoral activity and toxicity of gemcitabine was assessed according to World Health Organization criteria. Results: The obtained mean parameters, such as T_1/2 (elimination half time), AUC, and CL (clearance), were consistent with those reported in literature. Qualified response rate in our study was 33.3% for standard arm and 50% for FDR arm. Additional 50% and 33.3% patients contracted stable disease (SD) in standard arm and FDR arm, respectively. The predominant toxicity was hematologic, and patients in the standard infusion arm experienced consistently more hematologic toxicity. Conclusion: Pharmacokinetic and clinical data in this trial support the continued evaluation of the FDR infusion strategy with gemcitabine.

Key words: Gemcitabine, Non-small-cell lung cancer, Pharmacokinetics, Qualified response, Safety

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