Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study

The Lancet Oncology

Volumn 17, Issue 12, 2016, Pages 1643-1652

  Goss, Glenwood ^a   Tsai, Chun Ming ^b   Shepherd, Frances A ^c   Bazhenova, Lyudmila ^d   Lee, Jong Seok ^e   Chang, Gee Chen ^b   Crino, Lucio ^f   Satouchi, Miyako ^g   Chu, Quincy ^h   Hida, Toyoaki ⁱ   Han, Ji Youn ^j   Juan, Oscar ^k   Dunphy, Frank ^l   Nishio, Makoto ^m   Kang, Jin Hyoung ⁿ   Majem, Margarita ^o   Mann, Helen ^p   Cantarini, Mireille ^p   Ghiorghiu, Serban ^p   Mitsudomi, Tetsuya ^q  

^a OTTAWA REGIONAL CANCER CENTRE   (Canada)

^b NATIONAL YANG MING UNIVERSITY   (Taiwan)

^c PRINCESS MARGARET HOSPITAL   (Canada)

^d UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^e Seoul National University Bundang Hospital   (South Korea)

^f UNIVERSITY OF PERUGIA   (Italy)

^g HYOGO CANCER CENTER   (Japan)

^h UNIVERSITY OF ALBERTA   (Canada)

ⁱ AICHI CANCER CENTER HOSPITAL   (Japan)

^j National Cancer Center   (South Korea)

^k HOSPITAL UNIVERSITARIO LA FE   (Spain)

^l DUKE UNIVERSITY MEDICAL CENTER   (United States)

^m CANCER INSTITUTE HOSPITAL   (Japan)

ⁿ The Catholic University of Korea   (South Korea)

^o HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^p ASTRAZENECA   (United Kingdom)

^q KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AFATINIB; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATINE KINASE; DACOMITINIB; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; GEFITINIB; METHIONINE; OSIMERTINIB; PLATINUM COMPLEX; THREONINE; ANTINEOPLASTIC AGENT; EGFR PROTEIN, HUMAN; PIPERAZINE DERIVATIVE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASPIRATION PNEUMONIA; BACKACHE; BRAIN INFARCTION; CREATINE KINASE BLOOD LEVEL; DEHYDRATION; DIARRHEA; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; EGFR GENE; FAILURE TO THRIVE; FEMALE; FEVER; GENE MUTATION; HUMAN; HYPONATREMIA; HYPOXIA; INTERSTITIAL LUNG DISEASE; JAUNDICE; LEUKOCYTE COUNT; LEUKOPENIA; LUNG EMBOLISM; LUNG INFECTION; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NECK PAIN; NEUTROPENIA; NEUTROPHIL COUNT; NON SMALL CELL LUNG CANCER; OPEN STUDY; PARONYCHIA; PHASE 2 CLINICAL TRIAL; PLEURISY; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; QT PROLONGATION; RASH; RECTUM HEMORRHAGE; SIDE EFFECT; SPLEEN INFARCTION; STEADY STATE; STOMATITIS; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TOXIC HEPATITIS; ANTAGONISTS AND INHIBITORS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; GENETICS; LUNG NEOPLASMS; MIDDLE AGED; MUTATION; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; MUTATION; PIPERAZINES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 85001697105     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(16)30508-3     Document Type: Article

References (30)

1. 1 Reck, M, Popat, S, Reinmuth, N, De Ruysscher, D, Kerr, KM, Peters, S, Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 25 (2014), 27–39.
2. 2 Keedy, VL, Temin, S, Somerfield, MR, et al. American Society of Clinical Oncology provisional clinical opinion: epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non-small-cell lung cancer considering first-line EGFR tyrosine kinase inhibitor therapy. J Clin Oncol 29 (2011), 2121–2127.
3. 3 Mok, TS, Wu, YL, Thongprasert, S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361 (2009), 947–957.
4. 4 Rosell, R, Carcereny, E, Gervais, R, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol 13 (2012), 239–246.
5. 5 Sequist, LV, Yang, JC, Yamamoto, N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 31 (2013), 3327–3334.
6. 6 Tan, DS, Yom, SS, Tsao, MS, et al. The International Association for the Study of Lung Cancer consensus statement on optimizing management of EGFR mutation-positive non-small cell lung cancer: status in 2016. J Thorac Oncol 11 (2016), 946–963.
7. 7 Arcila, ME, Oxnard, GR, Nafa, K, et al. Rebiopsy of lung cancer patients with acquired resistance to EGFR inhibitors and enhanced detection of the T790M mutation using a locked nucleic acid-based assay. Clin Cancer Res 17 (2011), 1169–1180.
8. 8 Kuiper, JL, Heideman, DA, Thunnissen, E, et al. Incidence of T790M mutation in (sequential) rebiopsies in EGFR-mutated NSCLC-patients. Lung Cancer 85 (2014), 19–24.
9. 9 Li, W, Ren, S, Li, J, et al. T790M mutation is associated with better efficacy of treatment beyond progression with EGFR-TKI in advanced NSCLC patients. Lung Cancer 84 (2014), 295–300.
10. 10 Oxnard, GR, Arcila, ME, Sima, CS, et al. Acquired resistance to EGFR tyrosine kinase inhibitors in EGFR-mutant lung cancer: distinct natural history of patients with tumors harboring the T790M mutation. Clin Cancer Res 17 (2011), 1616–1622.
11. 11 Sun, JM, Ahn, MJ, Choi, YL, Ahn, JS, Park, K, Clinical implications of T790M mutation in patients with acquired resistance to EGFR tyrosine kinase inhibitors. Lung Cancer 82 (2013), 294–298.
12. 12 Wu, SG, Liu, YN, Tsai, MF, et al. The mechanism of acquired resistance to irreversible EGFR tyrosine kinase inhibitor-afatinib in lung adenocarcinoma patients. Oncotarget 7 (2016), 12404–12413.
13. 13 Yu, HA, Arcila, ME, Rekhtman, N, et al. Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers. Clin Cancer Res 19 (2013), 2240–2247.
14. 14 Gridelli, C, Ciardiello, F, Gallo, C, et al. First-line erlotinib followed by second-line cisplatin-gemcitabine chemotherapy in advanced non-small-cell lung cancer: the TORCH randomized trial. J Clin Oncol 30 (2012), 3002–3011.
15. 15 Soria, JC, Wu, YL, Nakagawa, K, et al. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol 16 (2015), 990–998.
16. 16 Schuler, M, Yang, JC, Park, K, et al. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial. Ann Oncol 27 (2016), 417–423.
17. 17 National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology NSCLC (version 4.2016). http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf, 2016 (accessed April 4, 2016).
18. 18 Cross, DA, Ashton, SE, Ghiorghiu, S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov 4 (2014), 1046–1061.
19. 19 Jänne, PA, Yang, JC, Kim, DW, et al. AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med 372 (2015), 1689–1699.
20. 20 Jänne, PA, Ahn, M-J, Kim, D-W, et al. Phase I study of AZD9291 in patients with EGFR-TKI-resistant advanced NSCLC—updated progression free survival and duration of response data. Ann Oncol, 26, 2015, i60.
21. 21 Osoba, D, Rodrigues, G, Myles, J, Zee, B, Pater, J, Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16 (1998), 139–144.
22. 22 Fayers, PM, Aaronson, NK, Bjordal, K, Groenvold, M, Curran, D, Bottomley, A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual, 3rd edn., 2001, European Organisation for Research and Treatment of Cancer, Brussels.
23. 23 Jackman, DM, Yeap, BY, Sequist, LV, et al. Exon 19 deletion mutations of epidermal growth factor receptor are associated with prolonged survival in non-small cell lung cancer patients treated with gefitinib or erlotinib. Clin Cancer Res 12 (2006), 3908–3914.
24. 24 Ke, E, Zhang, Q, Zhou, Q, Wu, Y-L, Clinical characteristics of T790M in pre and post treatment with EGFR TKIs. Ann Oncol, 26, 2015, ix143.
25. 25 Tan, DS-W, Seto, T, Leighl, NB, et al. First-in-human phase I study of EGF816, a third generation, mutant-selective EGFR tyrosine kinase inhibitor, in advanced non-small cell lung cancer (NSCLC) harboring T790M. Proc Am Soc Clin Oncol, 33, 2015 Abstr 8013.
26. 26 Yu, HA, Oxnard, GR, Spira, AI, et al. Phase I dose escalation study of ASP8273, a mutant-selective irreversible EGFR inhibitor, in subjects with EGFR mutation positive NSCLC. Proc Am Soc Clin Oncol, 33, 2015 Abstr 8083.
27. 27 Park, K, Lee, JS, Han, JY, et al. 1300: Efficacy and safety of BI 1482694 (HM61713), an EGFR mutant-specific inhibitor, in T790M-positive NSCLC at the recommended phase II dose. J Thorac Oncol, 11, 2016, S113.
28. 28 Miller, VA, Hirsh, V, Cadranel, J, et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol 13 (2012), 528–538.
29. 29 Ellis, PM, Shepherd, FA, Millward, M, et al. Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): a double-blind, randomised, phase 3 trial. Lancet Oncol 15 (2014), 1379–1388.
30. 30 Soria, J, Kim, S, Wu, Y, et al. Gefitinib/chemotherapy vs chemotherapy in EGFR mutation-positive NSCLC resistant to first-line gefitinib: IMPRESS T790M subgroup analysis. J Thorac Oncol, 10, 2015, S207.