Abstract | INTRODUCTION: CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT01121393. MATERIALS AND METHODS: Previously untreated patients with EGFR mutation-positive stage IIIB/IV lung adenocarcinoma were randomized 2:1 to receive afatinib or ≤6 cycles of gemcitabine/ cisplatin. The key outcomes were progression-free survival (PFS; primary), objective response rate, disease control rate, overall survival (OS), duration of response and disease control, patient-reported outcomes, and safety. Three hundred and twenty-seven patients from mainland China were treated (89.8% of overall LUX-Lung 6 population; afatinib 217, gemcitabine/ cisplatin 110). RESULTS: PFS was significantly longer with afatinib than gemcitabine/ cisplatin (median 11.0 versus 5.6 months; hazard ratio [HR], 0.30 [95% CI, 0.21, 0.43]; P,0.0001). Overall, there was no significant difference in OS between treatment arms; however, in a subgroup analysis, afatinib significantly improved OS versus gemcitabine/ cisplatin in patients with an EGFR Del19 mutation (median 31.6 versus 16.3 months; HR, 0.61 [95% CI, 0.41, 0.91]; P=0.0146). Afatinib was well tolerated, with most treatment-related adverse events (TRAEs) being of grade 1 or 2 severity. The most common grade 3/4 TRAEs with afatinib were rash/ acne (15.9%/0.5%), stomatitis (6.1%/0%), and diarrhea (5.6%/0%). TRAEs leading to permanent discontinuation were reported in 12 patients (5.6%) receiving afatinib and 43 (41.7%) receiving gemcitabine/ cisplatin. Afatinib significantly improved PFS compared with standard first-line chemotherapy in Chinese patients with EGFR mutation-positive NSCLC and demonstrated a manageable safety profile. CONCLUSION: The findings support the rationale for using afatinib as a first-line treatment option for this patient population.
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Authors | Yi-Long Wu, Chong-Rui Xu, Cheng-Ping Hu, Jifeng Feng, Shun Lu, Yunchao Huang, Wei Li, Mei Hou, Jian Hua Shi, Angela Märten, Jean Fan, Barbara Peil, Caicun Zhou |
Journal | OncoTargets and therapy
(Onco Targets Ther)
Vol. 11
Pg. 8575-8587
( 2018)
ISSN: 1178-6930 [Print] New Zealand |
PMID | 30584317
(Publication Type: Journal Article)
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