The role of afatinib in the management of non-small cell lung carcinoma

Bibliography

• National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: non-Small Cell Lung Cancer. 2012. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp
   Google Scholar
• Travis WD, Brambilla E, Riely GJ. New pathologic classification of lung cancer: relevance for clinical practice and clinical trials. J Clin Oncol 2013;31(8):992–1001
   PubMed Web of Science ®Google Scholar
• Ramalingam S, Belani C. Systemic chemotherapy for advanced non-small cell lung cancer: recent advances and future directions. Oncologist 2008;13(Suppl 1):5–13
   PubMed Web of Science ®Google Scholar
• Yap TA, Workman P. Exploiting the cancer genome: strategies for the discovery and clinical development of targeted molecular therapeutics. Annu Rev Pharmacol Toxicol 2012;52:549–73
   PubMed Web of Science ®Google Scholar
• Yap TA, Sandhu SK, Workman P, de Bono JS. Envisioning the future of early anticancer drug development. Nat Rev Cancer 2010;10(7):514–23
   PubMed Web of Science ®Google Scholar
• Pao W, Chmielecki J. Rational, biologically based treatment of EGFR-mutant non-small-cell lung cancer. Nat Rev Cancer 2010;10(11):760–74
   PubMed Web of Science ®Google Scholar
• Weinstein IB. Cancer. Addiction to oncogenes–the Achilles heal of cancer. Science 2002;297(5578):63–4
   PubMed Web of Science ®Google Scholar
• Weinstein IB, Joe AK. Mechanisms of disease: oncogene addiction–a rationale for molecular targeting in cancer therapy. Nat Clin Pract Oncol 2006;3(8):448–57
   PubMedGoogle Scholar
• Hynes NE, Lane HA. ERBB receptors and cancer: the complexity of targeted inhibitors. Nat Rev Cancer 2005;5(5):341–54
   PubMed Web of Science ®Google Scholar
• Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361(10):947–57
   PubMed Web of Science ®Google Scholar
• Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 2010;11(2):121–8
   PubMed Web of Science ®Google Scholar
• Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010;362(25):2380–8
   PubMed Web of Science ®Google Scholar
• Kobayashi S, Boggon TJ, Dayaram T, et al. EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. N Engl J Med 2005;352(8):786–92
   PubMed Web of Science ®Google Scholar
• Pao W, Miller VA, Politi KA, et al. Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med 2005;2(3):e73
   PubMed Web of Science ®Google Scholar
• Maheswaran S, Sequist LV, Nagrath S, et al. Detection of mutations in EGFR in circulating lung-cancer cells. N Engl J Med 2008;359(4):366–77
   PubMed Web of Science ®Google Scholar
• Oxnard GR, Arcila ME, Chmielecki J, et al. New strategies in overcoming acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in lung cancer. Clin Cancer Res 2011;17(17):5530–7
   PubMed Web of Science ®Google Scholar
• Johnson ML, Riely GJ, Rizvi NA, et al. Phase II trial of dasatinib for patients with acquired resistance to treatment with the epidermal growth factor receptor tyrosine kinase inhibitors erlotinib or gefitinib. J Thorac Oncol 2011;6(6):1128–31
   PubMed Web of Science ®Google Scholar
• Sequist LV, Besse B, Lynch TJ, et al. Neratinib, an irreversible pan-ErbB receptor tyrosine kinase inhibitor: results of a phase II trial in patients with advanced non-small-cell lung cancer. J Clin Oncol 2010;28(18):3076–83
   PubMed Web of Science ®Google Scholar
• Janjigian YY, Azzoli CG, Krug LM, et al. Phase I/II trial of cetuximab and erlotinib in patients with lung adenocarcinoma and acquired resistance to erlotinib. Clin Cancer Res 2011;17(8):2521–7
   PubMed Web of Science ®Google Scholar
• Riely GJ, Kris MG, Zhao B, et al. Prospective assessment of discontinuation and reinitiation of erlotinib or gefitinib in patients with acquired resistance to erlotinib or gefitinib followed by the addition of everolimus. Clin Cancer Res 2007;13(17):5150–5
   PubMed Web of Science ®Google Scholar
• Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther 2012;343(2):342–50
   PubMed Web of Science ®Google Scholar
• Li D, Ambrogio L, Shimamura T, et al. BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models. Oncogene 2008;27(34):4702–11
   PubMed Web of Science ®Google Scholar
• Bean J, Riely GJ, Balak M, et al. Acquired resistance to epidermal growth factor receptor kinase inhibitors associated with a novel T854A mutation in a patient with EGFR-mutant lung adenocarcinoma. Clin Cancer Res 2008;14(22):7519–25
   PubMed Web of Science ®Google Scholar
• Stopfer P, Marzin K, Narjes H, et al. Afatinib pharmacokinetics and metabolism after oral administration to healthy male volunteers. Cancer Chemother Pharmacol 2012;69(4):1051–61
   PubMed Web of Science ®Google Scholar
• Yap TA, Vidal L, Adam J, et al. Phase I trial of the irreversible EGFR and HER2 kinase inhibitor BIBW 2992 in patients with advanced solid tumors. J Clin Oncol 2010;28(25):3965–72
   PubMed Web of Science ®Google Scholar
• Wind S, Schmid M, Erhardt J, et al. Pharmacokinetics of afatinib, a selective irreversible ErbB family blocker, in patients with advanced solid tumours. Clin Pharmacokinet 2013; Epub ahead of print
   PubMed Web of Science ®Google Scholar
• Eskens FA, Mom CH, Planting AS, et al. A phase I dose escalation study of BIBW 2992, an irreversible dual inhibitor of epidermal growth factor receptor 1 (EGFR) and 2 (HER2) tyrosine kinase in a 2-week on, 2-week off schedule in patients with advanced solid tumours. Br J Cancer 2008;98(1):80–5
   PubMed Web of Science ®Google Scholar
• Lewis N, Marshall J, Amelsberg A, et al. A phase I dose escalation study of BIBW 2992, an irreversible dual EGFR/HER2 receptor tyrosine kinase inhibitor, in a 3 week on 1 week off schedule in patients with advanced solid tumours. 2006 ASCO Annual Meeting Proceedings Part I. J Clin Oncol, 2006. 24(18s June 20 Suppl):abstract 3091
   Google Scholar
• Agus DB, Terlizzi E, Stopfer P, et al. A phase I dose escalation study of BIBW 2992, an irreversible dual EGFR/HER2 receptor tyrosine kinase inhibitor, in a continuous schedule in patients with advanced solid tumours. 2006 ASCO Annual Meeting Proceedings Part I. J Clin Oncol 2006. 24(18s June 20 Suppl):abstract 2074
   Google Scholar
• 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 2012;13(5):528–38
   PubMed Web of Science ®Google Scholar
• Hirsh V, Cadranel J, Cong XJ, et al. Symptom and quality of life benefit of afatinib in advanced non-small-cell lung cancer patients previously treated with erlotinib or gefitinib: results of a randomized phase IIb/III trial (LUX-Lung 1). J Thorac Oncol 2013;8(2):229–37
   PubMed Web of Science ®Google Scholar
• Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353(2):123–32
   PubMed Web of Science ®Google Scholar
• Pazdur R. Endpoints for assessing drug activity in clinical trials. Oncologist 2008;13(Suppl 2):19–21
   PubMed Web of Science ®Google Scholar
• Jackman D, Pao W, Riely GJ, et al. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol 2010;28(2):357–60
   PubMed Web of Science ®Google Scholar
• Yang JC, Shih JY, Su WC, et al. Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial. Lancet Oncol 2012;13(5):539–48
   PubMed Web of Science ®Google Scholar
• Metro G, Crino L. The LUX-Lung clinical trial program of afatinib for non-small-cell lung cancer. Expert Rev Anticancer Ther 2011;11(5):673–82
   PubMed Web of Science ®Google Scholar
• 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 2013; Epub ahead of print
   Google Scholar
• Yang JC, Hirsh V, Schuler M, et al. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013; Epub ahead of print
   Google Scholar
• Katakami N, Atagi S, Goto K, et al. LUX-Lung 4: a phase II trial of afatinib in patients with advanced non-small-cell lung cancer who progressed during prior treatment with erlotinib, gefitinib, or both. J Clin Oncol 2013; Epub ahead of print
   PubMedGoogle Scholar
• Schuler MH, Planchard D, Yang JCH, et al. Interim analysis of afatinib monotherapy in patients with metastatic NSCLC progressing after chemotherapy and erlotinib/gefitinib (E/G) in a trial of afatinib plus paclitaxel versus investigator's choice chemotherapy following progression on afatinib monotherapy. J Clin Oncol 2012;30(Suppl):abstract 7557
   Google Scholar
• Available from: www.clinicaltrials.gov
   Google Scholar
• Wu YL, Zhou C, Hu CP, et al. LUX-Lung 6: a randomized, open-label, phase III study of afatinib (A) versus gemcitabine/cisplatin (GC) as first-line treatment for Asian patients (pts) with EGFR mutation-positive (EGFR M+) advanced adenocarcinoma of the lung. J Clin Oncol 2013;31(Suppl):abstract 8016
   Google Scholar
• Ramalingam SS, Blackhall F, Krzakowski M, et al. Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer. J Clin Oncol 2012;30(27):3337–44
   PubMed Web of Science ®Google Scholar
• Janjigian YY, Groen HJ, Horn L, et al. Activity and tolerability of afatinib (BIBW 2992) and cetuximab in NSCLC patients with acquired resistance to erlotinib or gefitinib. J Clin Oncol (Meeting Abstracts) 2011;29(15_Suppl):7525
   Google Scholar
• Janjigian YY, Smit EF, Horn L, et al. Activity of afatinib/cetuximab in patients (pts) with EGFR mutant non-small cell lung cancer (NSCLC) and acquired resistance (AR) to EGFR inhibitors [abstract 1289]. ESMO 2012 Congress; 2012
   Google Scholar
• Nelson V, Ziehr J, Agulnik M, Johnson M. Afatinib: emerging next-generation tyrosine kinase inhibitor for NSCLC. Oncol Targets Ther 2013;6:135–43
   PubMed Web of Science ®Google Scholar
• Cortot AB, Repellin CE, Shimamura T, et al. Resistance to irreversible EGF receptor tyrosine kinase inhibitors through a multistep mechanism involving the IGF1R pathway. Cancer Res 2013;73(2):834–43
   PubMed Web of Science ®Google Scholar
• Walter AO, Tjin R, Haringsma H, et al. CO-1686, a novel mutant-selective EGFR inhibitor, overcomes T790M mediated resistance in non-small cell lung cancer (NSCLC). Cancer Res 2012;72(8 Suppl):1791
   Google Scholar