Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations.

Autor:	Mok TS; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Cheng Y; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Zhou X; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Lee KH; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Nakagawa K; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Niho S; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Lee M; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Linke R; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Rosell R; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Corral J; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Migliorino MR; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Pluzanski A; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Sbar EI; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Wang T; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., White JL; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT., Wu YL; 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 Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2018 Aug 01; Vol. 36 (22), pp. 2244-2250. Date of Electronic Publication: 2018 Jun 04.
DOI:	10.1200/JCO.2018.78.7994
Abstrakt:	Purpose 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. Patients and Methods 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. Results 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. Conclusion 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.
Databáze:	MEDLINE
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