학술논문
Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer
Document Type
Report
Author
Source
BMC Cancer. April 9, 2016, Vol. 16 Issue 265
Subject
Language
English
ISSN
1471-2407
Abstract
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.sup.2, day 1) and amrubicin (40 mg/m.sup.2, days 1-3) once every 21 days. EP-treated patients received cisplatin (80 mg/m.sup.2, day 1) and etoposide (100 mg/m.sup.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. Trial registration This trial was registered on 10 April 2008 (ClinicalTrials.gov NCT00660504). Keywords: Amrubicin, Cisplatin, Etoposide, ED-SCLC, Randomized clinical trial, Chinese
Author(s): Yan Sun[sup.1] , Ying Cheng[sup.2] , Xuezhi Hao[sup.1] , Jie Wang[sup.3] , Chengping Hu[sup.4] , Baohui Han[sup.5] , Xiaoqing Liu[sup.6] , Li Zhang[sup.7] , Huiping Wan[sup.8] , Zhongjun Xia[sup.9] [...]
Author(s): Yan Sun[sup.1] , Ying Cheng[sup.2] , Xuezhi Hao[sup.1] , Jie Wang[sup.3] , Chengping Hu[sup.4] , Baohui Han[sup.5] , Xiaoqing Liu[sup.6] , Li Zhang[sup.7] , Huiping Wan[sup.8] , Zhongjun Xia[sup.9] [...]