机构：[1]Department of Internal Medicine, Cancer Institute & Hospital, ChineseAcademy of Medical Sciences & Peking Union Medical College, Beijing,China[2]Department of Internal Medicine, Jilin Cancer Hospital, Jilin, China[3]Department of Medical Oncology, Beijing Cancer Hospital, Beijing, China[4]Department of Respiratory Medicine, Xiangya Hospital of Central-SouthUniversity, Hunan, China[5]Department of Pulmonary Medicine, ShanghaiChest Hospital, Shanghai, China[6]Department of Lung Cancer Medicine,307th Hospital of the Chinese People’s Liberation Army, Beijing, China[7]Department of Respiratory Medicine, Peking Union Medical CollegeHospital, Chinese Academy of Medical Sciences, Beijing, China[8]Departmentof Medical Oncology, Jiangxi Provincial People’s Hospital, Jiangxi, China[9]Department of Medical Oncology, Affiliated Cancer Hospital of Sun Yat-senUniversity, Guangdong, China[10]Department of Medical Oncology, The FirstHospital of China Medical University, Liaoning, China[11]Department ofMedical Oncology, The First Hospital of Jilin University, Jilin, China[12]Department of Medical Oncology, West China Hospital, Sichuan University,Sichuan, China四川大学华西医院[13]Department of Medical Oncology, Tangdu Hospital of theFourth Military Medical University, Shanxi, China[14]Department of RespiratoryMedicine, Shanghai Changzheng Hospital, Shanghai, China[15]Department ofMedical Oncology, Beijing Chest Hospital, Beijing, China[16]Department ofMedical Oncology, Jiangsu Cancer Hospital, Jiangsu, China[17]Department ofMedical Oncology, 81st Hospital of the Chinese People’s Liberation Army,Jiangsu, China[18]Medical Division, Sumitomo Pharmaceuticals (Suzhou) Co.,Ltd., Beijing, China
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.
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.
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.
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.
This trial was registered on 10 April 2008 (ClinicalTrials.gov NCT00660504).
第一作者机构：[1]Department of Internal Medicine, Cancer Institute & Hospital, ChineseAcademy of Medical Sciences & Peking Union Medical College, Beijing,China
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推荐引用方式(GB/T 7714)：
Yan Sun,Ying Cheng,Xuezhi Hao,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:doi:10.1186/s12885-016-2301-6.
APA：
Yan Sun,Ying Cheng,Xuezhi Hao,Jie Wang,Chengping Hu...&Xiaoyan Luo.(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：
Yan Sun,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)
医学