Gemcitabine and cisplatin treatment over a 3-week versus a 4-week dosing schedule： a randomized trial coducted in Chinese patients with nonsmall cell lung cancer  

作　　者：LIAO Mei-lin ZHU Yun-zhong LI Long-yun WAN Huan-ying YU Shi-ying Belinda HALL Teena WEST WANG Li 

机构地区：[1]Clinical Medical Centre of Lung Tumour, Shanghai ChestHospital, Shanghai 200030, China [2]Department of Oncology, Beijing Chest Tumour Hospital, Beijing 101149, China [3]Department of Pulmonary Medicine, Peking Union Hospital,Beijing 100730, China [4]Department of Pulmonary Medicine, Shanghai Ruijin Hospital,Shanghai 20025, China [5]Center of Oncology, Tongji Hospital, Wuhan 430030, China [6]Intercontinental Information Sciences, Eli Lilly Australia PtyLimited, Australia [7]Eli Lilly Asia, Shanghai Office, Shanghai 200021, China

出　　处：《Chinese Medical Journal》2008年第10期892-897,共6页中华医学杂志（英文版）

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 a 3-week versus a 4-week schedule of gemcitabine-cisplatin as first line treatment for Chinese patients with advanced NSCLC. Methods Patients were randomized to receive cisplatin 75 mg/m^2 on day 1 plus either gemcitabine 1250 mg/m^2 on days 1 and 8 of a 21-day cycle （3-week group） or gemcitabine 1000 mg/m2 on days 1,8 and 15 of a 28-day cycle （4-week group）. Results One hundred patients were enrolled in this study. The response rate was 24% （12/51 patients） in the 3-week group and 27% （13/49 patients） in the 4-week group. There were no statistically significant differences between the two treatment groups in survival （hazard ratio： 1.19; 95% CI： 0.68-2.09） with a median survival of 12.1 months and 13.8 months in the 3-week group and the 4-week group respectively. The rate of grade 3/4 toxicity in the 3-week group was 55% compared with 86% in the 4-week group （P=0.001）. The difference in the incidence of grade 3/4 haematological toxicities did not reach statistical significance （3-week： 37%, 4-week： 57%）, however grade 3/4 drug related neutropenia （3-week： 27%, 4-week： 51%） and thrombocytopenia （3-week： 8%, 4-week： 31%） were significantly lower in the 3-week group. Grade 3/4 nonhaematological toxicities were less in the 3-week group （33% cf 63%; P=0.005）. Conclusions The differences in the efficacy endpoints were all in favour of the 4-week schedule of gemcitabine plus cisplatin, however these differences did not reach statistical significance. Fewer grade 3/4 toxicities were observed in the 3-week group compared with the 4-week group.Background Gemcitabine plus cisplatin is a standard treatment for stages IIIB and IV nonsmall cell lung cancer （NSCLC）. This randomized phase Ⅱ study evaluated a 3-week versus a 4-week schedule of gemcitabine-cisplatin as first line treatment for Chinese patients with advanced NSCLC. Methods Patients were randomized to receive cisplatin 75 mg/m^2 on day 1 plus either gemcitabine 1250 mg/m^2 on days 1 and 8 of a 21-day cycle （3-week group） or gemcitabine 1000 mg/m2 on days 1,8 and 15 of a 28-day cycle （4-week group）. Results One hundred patients were enrolled in this study. The response rate was 24% （12/51 patients） in the 3-week group and 27% （13/49 patients） in the 4-week group. There were no statistically significant differences between the two treatment groups in survival （hazard ratio： 1.19; 95% CI： 0.68-2.09） with a median survival of 12.1 months and 13.8 months in the 3-week group and the 4-week group respectively. The rate of grade 3/4 toxicity in the 3-week group was 55% compared with 86% in the 4-week group （P=0.001）. The difference in the incidence of grade 3/4 haematological toxicities did not reach statistical significance （3-week： 37%, 4-week： 57%）, however grade 3/4 drug related neutropenia （3-week： 27%, 4-week： 51%） and thrombocytopenia （3-week： 8%, 4-week： 31%） were significantly lower in the 3-week group. Grade 3/4 nonhaematological toxicities were less in the 3-week group （33% cf 63%; P=0.005）. Conclusions The differences in the efficacy endpoints were all in favour of the 4-week schedule of gemcitabine plus cisplatin, however these differences did not reach statistical significance. Fewer grade 3/4 toxicities were observed in the 3-week group compared with the 4-week group.

关 键 词：CHEMOTHERAPY GEMCITABINE CISPLATIN carcinoma  nonsmall cell lung 

分 类 号：R734.2[医药卫生—肿瘤]