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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.

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机构: [1]Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China [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 [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
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关键词: afatinib NSCLC EGFR first-line Phase III Chinese patients

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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.

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出版当年[2018]版:
大类 | 3 区 医学
小类 | 3 区 生物工程与应用微生物 4 区 肿瘤学
最新[2023]版:
大类 | 4 区 医学
小类 | 3 区 生物工程与应用微生物 4 区 肿瘤学
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出版当年[2017]版:
Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Q3 ONCOLOGY
最新[2023]版:
Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Q3 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

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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
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