Afatinib versus gemcitabine/cisplatin for first-line treatment of Chinese patients with advanced non-small-cell lung cancer harboring EGFR mutations: subgroup analysis of the LUX-Lung 6 trial.
机构：[1]Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China广东省人民医院[2]Department of Pulmonary Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China[3]Department of Internal Medicine, Jiangsu Provincial Tumor Hospital, Nanjing, Jiangsu, China[4]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China[5]Department of Thoracic Surgery, Yunnan Tumor Hospital (The Third Affiliated Hospital of Kunming Medical University), Kunming, Yunnan, China[6]Department of Hematology & Oncology, Cancer Center, First Hospital of Jilin University, Changchun, Jilin, China[7]Lung Cancer Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, China四川大学华西医院[8]Department of Oncology, Lin Yi Tumor Hospital, Linyi, Shandong, China[9]Department of Oncology, Boehringer Ingelheim GmbH, Ingelheim, Germany[10]Department of Oncology, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA[11]Department of Oncology, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany[12]Department of Medical Oncology, Shanghai Pulmonary Hospital, Yangpu District, Shanghai, China
Non-small-cell lung cancer (NSCLC) is the leading cause of cancer death in China. Four epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitors - afatinib, erlotinib, icotinib, and gefitinib - are available for first-line treatment of NSCLC in China; however, there are few data to guide treatment choice. The Phase III LUX-Lung 6 trial compared afatinib with platinum-based chemotherapy for first-line treatment of patients from Southeast Asia with EGFR mutation-positive advanced NSCLC. This post hoc analysis assessed the findings from LUX-Lung 6 in Chinese patients.
ClinicalTrials.gov: NCT01121393.
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).
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.
The findings support the rationale for using afatinib as a first-line treatment option for this patient population.
第一作者机构：[1]Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China[*1]Guangdong Lung Cancer Institute, Guangdong
通讯作者：
通讯机构：[1]Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China[*1]Guangdong Lung Cancer Institute, Guangdong
推荐引用方式(GB/T 7714)：
Wu Yi-Long,Xu Chong-Rui,Hu Cheng-Ping,et al.Afatinib versus gemcitabine/cisplatin for first-line treatment of Chinese patients with advanced non-small-cell lung cancer harboring EGFR mutations: subgroup analysis of the LUX-Lung 6 trial.[J].ONCOTARGETS AND THERAPY.2018,11:8575-8587.doi:10.2147/OTT.S160358.
APA：
Wu Yi-Long,Xu Chong-Rui,Hu Cheng-Ping,Feng Jifeng,Lu Shun...&Zhou Caicun.(2018).Afatinib versus gemcitabine/cisplatin for first-line treatment of Chinese patients with advanced non-small-cell lung cancer harboring EGFR mutations: subgroup analysis of the LUX-Lung 6 trial..ONCOTARGETS AND THERAPY,11,
MLA：
Wu Yi-Long,et al."Afatinib versus gemcitabine/cisplatin for first-line treatment of Chinese patients with advanced non-small-cell lung cancer harboring EGFR mutations: subgroup analysis of the LUX-Lung 6 trial.".ONCOTARGETS AND THERAPY 11.(2018):8575-8587
