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cisplatin as first-line treatment for extensive small-cell lung cancer 期刊论文

编号：

816e8e8e-4606-4a92-86b0-98713d77ef67
作者：

Sun, Yan(孙燕)#*^[1,2]Cheng, Ying(程颖)#^[3]Hao, Xuezhi^[1,2];Wang, Jie^[4];Hu, Chengping^[5];Han, Baohui^[6];Liu, Xiaoqing^[7];Zhang, Li^[8];Wan, Huiping^[9];Xia, Zhongjun^[10];Liu, Yunpeng^[11];Li, Wei(李薇)^[12]Hou, Mei^[13];Zhang, Helong^[14];Xiu, Qingyu^[15];Zhu, Yunzhong^[16];Feng, Jifeng^[17];Qin, Shukui^[18];Luo, Xiaoyan^[19];
语种：

英文
期刊：

BMC CANCER ISSN：1471-2407 2016 年 16 卷 ; APR 9
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关键词：

Amrubicin Cisplatin Etoposide ED-SCLC Randomized clinical trial Chinese
摘要：

Background: Extensive-disease small-cell lung cancer (ED-SCLC) is characterized by rapid progression and relapse, despite high initial response rates to chemotherapy. The primary objective of this trial was to demonstrate the non-inferiority of amrubicin and cisplatin (AP) combination therapy compared with the standard first-line regimen of etoposide and cisplatin (EP) for previously untreated ED-SCLC in a Chinese population. When non-inferiority was verified, the objective was switched from non-inferiority to superiority.
Methods: From June 2008 to July 2010, 300 patients were enrolled and randomly assigned at a 1: 1 ratio to AP and EP groups. AP-treated patients received cisplatin (60 mg/m(2), day 1) and amrubicin (40 mg/m(2), days 1-3) once every 21 days. EP-treated patients received cisplatin (80 mg/m(2), day 1) and etoposide (100 mg/m(2), days 1-3) once every 21 days. Treatment was continued for four to six cycles, except in cases of progressive disease or toxicity, and patient refusal.
Results: Median overall survival (OS) for AP vs. EP treatment was 11.8 vs. 10.3 months (p = 0.08), respectively, demonstrating non-inferiority of AP to EP (AP group: 95 % confidence interval for hazard ratio 0.63-1.03 months). Median progression-free survival and overall response rates for AP vs. EP groups were 6.8 vs. 5.7 months (p = 0.35) and 69.8 % vs. 57.3 %, respectively. Drug-related adverse events in both groups were similar, with neutropenia being the most frequent (AP 54.4 %; EP 44.0 %). Leukopenia, pyrexia, and fatigue were more prevalent in the AP group, but all were clinically reversible and manageable.
Conclusions: AP therapy demonstrated non-inferiority to EP therapy, prolonging OS for 1.5 months, but this difference was not statistically significant; thus we propose AP as a promising treatment option for ED-SCLC in China.
推荐引用方式
GB/T 7714：

Sun Yan,Cheng Ying,Hao Xuezhi, et al. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer [J].BMC CANCER,2016,16.
APA：

Sun Yan,Cheng Ying,Hao Xuezhi,Wang Jie,&Luo Xiaoyan.(2016).Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer .BMC CANCER,16.
MLA：

Sun Yan, et al. "Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer" .BMC CANCER 16(2016).
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