TY - JOUR
T1 - A single-arm, multicenter, safety-monitoring, phase IV study of icotinib in treating advanced non-small cell lung cancer (NSCLC)
AU - Hu, Xingsheng
AU - Han, Baohui
AU - Gu, Aiqin
AU - Zhang, Yiping
AU - Jiao, Shun Chang
AU - Wang, Chang li
AU - He, Jintao
AU - Jia, Xueke
AU - Zhang, Li
AU - Peng, Jiewen
AU - Wu, Meina
AU - Ying, Kejing
AU - Wang, Junye
AU - Ma, Kewei
AU - Zhang, Shucai
AU - You, Changxuan
AU - Tan, Fenlai
AU - Wang, Yinxiang
AU - Ding, Lieming
AU - Sun, Yan
N1 - Funding Information:
The authors would like to thank all participating physicians and registered patients. This research was supported by Betta Pharmaceuticals Co., Ltd and partly supported by the Chinese Government through grants from the Key Special Program for Innovative Drugs ( 2008ZX09101 ). No writing assistance was involved in this article.
Publisher Copyright:
© 2014 Elsevier Ireland Ltd.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - Background: The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China. Methods: This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLC patients who received oral icotinib 125. mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients. Results: Between August, 2011 and August, 2012, a total of 6087 advanced NSCLC patients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively. Conclusions: The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting.
AB - Background: The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China. Methods: This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLC patients who received oral icotinib 125. mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients. Results: Between August, 2011 and August, 2012, a total of 6087 advanced NSCLC patients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively. Conclusions: The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting.
KW - EGFR TKIs
KW - Efficacy
KW - Icotinib
KW - Non-small-cell lung cancer
KW - Phase IV
KW - Real-world study
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=84908453682&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2014.08.014
DO - 10.1016/j.lungcan.2014.08.014
M3 - Article
C2 - 25261231
AN - SCOPUS:84908453682
SN - 0169-5002
VL - 86
SP - 207
EP - 212
JO - Lung Cancer
JF - Lung Cancer
IS - 2
ER -