BACKGROUND: The phase 3 ICOGEN trial established the non-inferiority of @entity41059 to @entity4562 in terms of progression-free survival (PFS) in @entity1149 ( @entity1149 ) @entity1 , and this led to the approval of @entity41059 for @entity1149 by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of @entity41059 in a broad range of @entity1 with advanced @entity1149 across China. METHODS: This study retrospectively analyzed data from unresectable, recurrent, and/or advanced @entity1149 @entity1 who received oral @entity41059 125mg 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 @entity1 with an @entity470 mutation and elderly @entity1 . RESULTS: Between August, 2011 and August, 2012, a total of 6087 advanced @entity1149 @entity1 were registered in this study, of which 5549 were evaluable for safety and @entity5 response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) @entity1 were over the age of 70. The majority of @entity1 were non-smokers, and had @entity420 and @entity5 . The overall incidence of @entity137 ( @entity137 ) of any grade was 31.5%. The most common @entity137 included @entity1910 (17.4%) and @entity294 (8.5%), and three @entity1 experienced @entity401 ( @entity401 ). 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 @entity470 -mutated @entity1 who were evaluable for @entity5 response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively. CONCLUSIONS: The data from over 6000 @entity1 was consistent with the results of the ICOGEN study. @entity41059 demonstrated a favorable @entity137 profile and efficacy in the routine clinical setting.

A single-arm, multicenter, safety-monitoring, phase IV study of @entity41059 in treating advanced @entity1149 ( XXXX ).

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'adverse drug reactions', 'ADRs'] @entity4562 :: ('MESH:C419708', 'Chemical') :: ['gefitinib'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity470 :: ('1956', 'Gene') :: ['EGFR'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'stage IV disease'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small cell lung cancer'] @entity41059 :: ('MESH:C531470', 'Chemical') :: ['icotinib', 'Icotinib'] @entity401 :: ('MESH:D017563', 'Disease') :: ['ILD', 'interstitial lung disease'] @entity420 :: ('MESH:D000230', 'Disease') :: ['adenocarcinoma']
@entity1149 :: (MESH:D002289,Disease) :: ['NSCLC']
