Gemcitabine and cisplatin treatment over a 3-week versus a 4-week dosing schedule: a randomized trial conducted in Chinese patients with nonsmall cell lung cancer.
作者： Mei-lin LIAO , Yun-zhong ZHU , Long-yun LI , Huan-ying WAN , Shi-ying YU
DOI: 10.1097/00029330-200805020-00006
关键词: Statistical significance 、 Phases of clinical research 、 Oncology 、 Internal medicine 、 Standard treatment 、 Randomized controlled trial 、 Hazard ratio 、 Gemcitabine 、 Chemotherapy 、 Gastroenterology 、 Neutropenia 、 Medicine
摘要: Background Gemcitabine plus cisplatin is a standard treatment for stages IIIB and IV nonsmall cell lung cancer (NSCLC). This randomized phase II study evaluated 3-week versus 4-week schedule of gemcitabine-cisplatin as first line Chinese patients with advanced NSCLC. Methods Patients were to receive 75 mg/m(2) on day 1 either gemcitabine 1250 days 8 21-day cycle (3-week group) or 1000 1, 15 28-day (4-week group). Results One hundred enrolled in this study. The response rate was 24% (12/51 patients) the group 27% (13/49 group. There no statistically significant differences between two groups survival (hazard ratio: 1.19; 95% CI: 0.68 - 2.09) median 12.1 months 13.8 respectively. grade 3/4 toxicity 55% compared 86% (P = 0.001). difference incidence haematological toxicities did not reach statistical significance (3-week: 37%, 4-week: 57%), however drug related neutropenia 27%, 51%) thrombocytopenia 8%, 31%) significantly lower Grade nonhaematological less (33% cf 63%; P 0.005). Conclusions efficacy endpoints all favour cisplatin, these significance. Fewer observed
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