Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non–Small-Cell Lung Cancer and <i>EGFR</i>-Activating Mutations
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- Tony S. Mok
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Ying Cheng
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Xiangdong Zhou
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Ki Hyeong Lee
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Kazuhiko Nakagawa
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Seiji Niho
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Min Lee
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Rolf Linke
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Rafael Rosell
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Jesus Corral
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Maria Rita Migliorino
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Adam Pluzanski
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Eric I. Sbar
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Tao Wang
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Jane Liang White
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
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- Yi-Long Wu
- Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko...
Description
<jats:sec><jats:title>Purpose</jats:title><jats:p> ARCHER 1050, a randomized, open-label, phase III study of dacomitinib versus gefitinib in treatment-naïve patients with advanced non–small-cell lung cancer (NSCLC) and activating mutations in EGFR, reported significant improvement in progression-free survival with dacomitinib. The mature overall survival (OS) analysis for the intention-to-treat population is presented here. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> In this multinational, multicenter study, patients age 18 years or older (≥ 20 years in Japan and Korea) who had an Eastern Cooperative Oncology Group performance status of 0 or 1 and newly diagnosed NSCLC with activating mutations in EGFR (exon 19 deletion or exon 21 L858R) were enrolled and randomly assigned in a 1:1 manner to dacomitinib (n = 227) or gefitinib (n = 225). Random assignment was stratified by race (Japanese, Chinese, other East Asian, or non-Asian) and EGFR mutation type. The final OS analysis was conducted with a data cutoff date of February 17, 2017; at that time 220 deaths (48.7%) were observed. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> During a median follow-up time of 31.3 months, 103 (45.4%) and 117 (52.0%) deaths occurred in the dacomitinib and gefitinib arms, respectively. The estimated hazard ratio for OS was 0.760 (95% CI, 0.582 to 0.993; two-sided P = .044). The median OS was 34.1 months with dacomitinib versus 26.8 months with gefitinib. The OS probabilities at 30 months were 56.2% and 46.3% with dacomitinib and gefitinib, respectively. Preliminary subgroup analyses for OS that are based on baseline characteristics were consistent with the primary OS analysis. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> In patients with advanced NSCLC and EGFR activating mutations, dacomitinib is the first second-generation epidermal growth factor receptor tyrosine kinase inhibitor (TKI) to show significant improvement in OS in a phase III randomized study compared with a standard-of-care TKI. Dacomitinib should be considered one of the standard treatment options for these patients. </jats:p></jats:sec>
Journal
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 36 (22), 2244-2250, 2018-08-01
American Society of Clinical Oncology (ASCO)
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Details 詳細情報について
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- CRID
- 1363951796024993024
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- ISSN
- 15277755
- 0732183X
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- Data Source
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- Crossref