Osimertinib in Pretreated T790M-Positive Advanced Non–Small-Cell Lung Cancer: AURA Study Phase II Extension Component
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- James Chih-Hsin Yang
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Myung-Ju Ahn
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Dong-Wan Kim
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Suresh S. Ramalingam
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Lecia V. Sequist
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Wu-Chou Su
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Sang-We Kim
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Joo-Hang Kim
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- David Planchard
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Enriqueta Felip
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Fiona Blackhall
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Daniel Haggstrom
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Kiyotaka Yoh
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Silvia Novello
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Kathryn Gold
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Tomonori Hirashima
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Chia-Chi Lin
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Helen Mann
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Mireille Cantarini
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Serban Ghiorghiu
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
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- Pasi A. Jänne
- James Chih-Hsin Yang and Chia-Chi Lin, National Taiwan University Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan, Republic of China; Myung-Ju Ahn, Sungkyunkwan University; Dong-Wan Kim, Seoul National University Hospital; Sang-We Kim, Asan Medical Center, Seoul; Joo-Hang Kim, CHA University, Gyeonggi-do, Republic of Korea; Suresh S. Ramalingam, Emory University School of Medicine, Atlanta, GA; Lecia V. Sequist, Massachusetts General Hospital; Pasi A. Jänne, Dana...
説明
<jats:sec><jats:title>Purpose</jats:title><jats:p> Osimertinib is an irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) selective for both EGFR-TKI sensitizing ( EGFRm) and T790M resistance mutations. AURA (NCT01802632) is a phase I/II clinical trial to determine the dose, safety, and efficacy of osimertinib. This article reports the results from the phase II extension component. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients with EGFR-TKI–pretreated EGFRm- and T790M-positive advanced non–small-cell lung cancer (NSCLC) received once-daily osimertinib 80 mg. T790M status was confirmed by central testing from a tumor sample taken after the most recent disease progression. Patients with asymptomatic, stable CNS metastases that did not require corticosteroids were allowed to enroll. The primary end point was objective response rate (ORR) by independent radiology assessment. Secondary end points were disease control rate, duration of response, progression-free survival (PFS), and safety. Patient-reported outcomes comprised an exploratory objective. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In total, 201 patients received treatment, with a median treatment duration of 13.2 months at the time of data cutoff (November 1, 2015). In evaluable patients (n = 198), ORR was 62% (95% CI, 54% to 68%), and the disease control rate was 90% (95% CI, 85 to 94). Median duration of response in 122 responding patients was 15.2 months (95% CI, 11.3 to not calculable). Median PFS was 12.3 months (95% CI, 9.5 to 13.8). The most common possibly causally related adverse events (investigator assessed) were diarrhea (43%; grade ≥ 3, < 1%) and rash (grouped terms; 40%; grade ≥ 3, < 1%). Interstitial lung disease (grouped terms) was reported in eight patients (4%; grade 1, n = 2; grade 3, n = 3; grade 5, n = 3). </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> In patients with EGFRm T790M advanced NSCLC who progress after EGFR-TKI treatment, osimertinib provides a high ORR, encouraging PFS, and durable response. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 35 (12), 1288-1296, 2017-04-20
American Society of Clinical Oncology (ASCO)