Afatinib for the treatment of advanced non-small-cell lung cancer

Bibliography

• NCCN Clinical practice guidelines in oncology: non-small cell lung cancer. Version 2. 2013. Available from: http:/www.nccn.org/professionals/physician_gls/pdf/nscl.pdf [Accessed on 26 December 2013]
   Google Scholar
• Rosell R, Moran T, Queralt C, et al. Spanish Lung Cancer Group. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009;361(10):958-67
   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
• Chi A, Remick S, Tse W. EGFR inhibition in non-small cell lung cancer: current evidence and future directions. Biomark Res 2013;1(1):2
   PubMedGoogle Scholar
• Lee CK, Brown C, Gralla RJ, et al. Impact of EGFR inhibitor in non-small cell lung cancer in progression-free and overall survival: a meta-analysis. J Natl Cancer Inst 2013;105(9):595-605
   PubMed Web of Science ®Google Scholar
• Shi Y, Zhang L, Liu X, et al. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol 2013;14(10):953-61
   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
• Nakata A, Gotoh N. Recent understanding of the molecular mechanisms for the efficacy and resistance of EGF receptor-specific tyrosine kinase inhibitors in non-small cell lung cancer. Expert Opin Ther Targets 2012;16(8):771-81
   PubMed Web of Science ®Google Scholar
• Yun CH, Mengwasser KE, Toms AV, et al. The T790M mutation in EGFR kinase causes drug resistance by increasing the affinity for ATP. Proc Natl Acad Sci USA 2008;105(6):2070-5
   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
• Landi L, Cappuzzo F. HER2 and lung cancer. Expert Rev Anticancer Ther 2013;13(10):1219-28
   PubMed Web of Science ®Google Scholar
• Nelson V, Ziehr J, Agulnik M, Johnson M. Afatinib: emerging next-generation tyrosine kinase inhibitor for NSCLC. Onco Targets Ther 2013;6:135-43
   PubMed Web of Science ®Google Scholar
• Takezawa K, Pirazzoli V, Arcila ME, et al. HER2 amplification: a potential mechanism of acquired resistance to EGFR inhibition in EGFR-mutant lung cancers that lack the second-site EGFRt790m mutation. Cancer Discov 2012;2(10):922-33
   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
• Giaccone G, Wang Y. Strategies for overcoming resistance to EGFR family tyrosine kinase inhibitors. Cancer Treat Rev 2011;37(6):456-64
   PubMed Web of Science ®Google Scholar
• Sun JM, Ahn MJ, Choi YL, et al. Clinical implications of T790M mutation in patients with acquired resistance to EGFR tyrosine kinase inhibitors. Lung Cancer 2013;82(2):294-8
   PubMed Web of Science ®Google Scholar
• Stopfer P, Marzin K, Narjes J, et al. Afatinib pharmacokinetics and metabolism after oral administration to healthy male volunteers. Cancer Chemother Pharmacol 2012;69:1051-61
   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;52(12):1101-9
   PubMedGoogle 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
• Gordon MS, Mendelson DS, Gross M, et al. A phase I, open-label, dose-escalation study of continuous once-daily oral treatment with afatinib in patients with advanced solid tumors. Invest New Drugs 2013;31(2):409-16
   PubMed Web of Science ®Google Scholar
• Marshall J, Hwang J, Eskens FA, et al. A phase I, open-label, dose escalation study of afatinib, in a 3-week-on/1-week-off schedule in patients with advanced solid tumors. Invest New Drugs 2013;2:399-408
   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
• Yang JC, Reguart N, Barinoff J, et al. Diarrhea associated with afatinib: an oral ErbB family blocker. Expert Rev Anticancer Ther 2013;13(6):729-36
   PubMed Web of Science ®Google Scholar
• Lacouture ME, Schadendorf D, Chu CY, et al. Dermatologic adverse events associated with afatinib: an oral ErbB family blocker. Expert Rev Anticancer Ther 2013;13(6):721-8
   PubMed Web of Science ®Google Scholar
• Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s000lbl.pdf [Accessed on 29 December 2013]
   Google Scholar
• Molife LR, Rudman SM, Alam S, et al. Phase II, open-label trial to assess QTcF effects, pharmacokinetics and antitumor activity of afatinib in patients with relapsed or refractory solid tumors. Cancer Chemother Pharmacol 2013;72(6):1213-22
   PubMed Web of Science ®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
• Murakami H, Tamura T, Takahashi T, et al. Phase I study of continuous afatinib (BIBW 2992) in patients with advanced non-small cell lung cancer after prior chemotherapy/erlotinib/gefitinib (LUX-Lung 4). Cancer Chemother Pharmacol 2012;69(4):891-9
   PubMed Web of Science ®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;31(27):3335-41
   PubMed Web of Science ®Google Scholar
• LUX-Lung 8: a phase III trial of afatinib (BIBW 2992) versus erlotinib for the treatment of squamous cell lung cancer after at least one prior platinum based chemotherapy (NCT01523587). Available from: www.clinicaltrials.gov/ct2/show/NCT01523587
   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
• 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;31(27):3327-34
   PubMed Web of Science ®Google Scholar
• Shuler M, Yang JC, Sequist LV, et al. Efficacy of afatinib vs. chemotherapy in treatment-naïve patients with non-small cell lung cancer (NSCLC) harbouring activating EGFR mutations with or without metastatic brain disease. J Thorac Oncol 2013;8(Suppl):abstract MO07.13
   Google Scholar
• Yang JC, Hirsh V, Shuler 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;31(27):3342-50
   PubMed Web of Science ®Google Scholar
• Wu JL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol 2014;15(2):213-22
   PubMed Web of Science ®Google Scholar
• Geater SL, Zhou C, Hu CP, et al. LUX-Lung 6: patient-reported outcomes (PROs) from a randomized open-label, phase III study in first-line advanced NSCLC patients (pts) harboring epidermal growth factor receptor (EGFR) mutations. J Clin Oncol 2013;31(Suppl):abstract 8061
   Google Scholar
• Yang JC, Sequist LV, Geater SL, et al. Activity of afatinib in uncommon epidermal growth factor receptor (EGFR) mutations: findings from three trials of afatinib in EGFR mutation-positive lung cancer. J Thorac Oncol 2013;8(Suppl):abstract O03.05-Presented at the 15th World Conference on Lung Cancer; 27 October- 30 October 2013; Sidney
   Google Scholar
• LUX-Lung 7: a phase IIb trial of afatinib (BIBW2992) versus gefitinib for the treatment of 1st line EGFR mutation positive adenocarcinoma of the lung (NCT01466660). Available from: www.clinicaltrials.gov/ct2/show/NCT01466660
   Google Scholar
• Kwak EL, Shapiro GI, Cohen SM, et al. Phase 2 trial of afatinib, an ErbB family blocker, in solid tumors genetically screened for target activation. Cancer 2013;119(16):3043-51
   PubMedGoogle Scholar
• Finocchiaro G, Santoro A, Grossi F, et al. Phase II study of afatinib (BIBW 2992), an irreversible ErbB family blocker, in patients with EGFR FISH-positive advanced NSCLC. Eur J Cancer 2011;47(S1):621-2
   Google Scholar
• De Greve J, Moran T, Graas MP, et al. Phase II study of afatinib, an irreversible ErbB family blocker, in demographically and genotypically defined non-small cell lung cancer (NSCLC) patients. J Clin Oncol 2013;31(Suppl):abstract 8063
   Google Scholar
• Awada AH, Dumez H, Endlisz A, et al. Phase I study of pulsatile 3-day administration of afatinib (BIBW 2992) in combination with docetaxel in advanced solid tumors. Invest New Drugs 2013;31(3):734-41
   PubMed Web of Science ®Google Scholar
• Marshall J, Shapiro GI, Uttenreuther-Fischer M, et al. Phase I dose-escalation study of afatinib, an ErbB family blocker, plus docetaxel in patients with advanced cancer. Future Oncol 2013;9(2):271-81
   PubMed Web of Science ®Google Scholar
• Vermorken JB, Rottey S, Ehrnrooth E, et al. A phase Ib, open-label study to assess the safety of continuous oral treatment with afatinib in combination with two chemotherapy regimens: cisplatin plus paclitaxel and cisplatin plus 5-fluorouracil, in patients with advanced solid tumors. Ann Oncol 2013;24(5):1392-400
   PubMed Web of Science ®Google Scholar
• Bahleda R, Soria J, Berge Y, et al. Phase I trial assessing safety and pharmacokinetics of afatinib (BIBW 2992) with intravenous weekly vinorelbine in advanced solid tumors. J Clin Oncol 2011;29(Suppl):abstract 2585
   Google Scholar
• Chu QS, Sangha RS, Hotte SJ, et al. A phase I, dose-escalation trial of continuous and pulsed-dose afatinib (A) combined with pemetrexed (P) in patients (pts) with advanced solid tumors: final analysis. J Clin Oncol 2013;31(Suppl):abstract 2523
   Google Scholar
• Shuler M, Planchard D, Yang JC, 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
• Kim JH, Grossi F, De Marinis F, et al. Afatinib monotherapy in patients with metastatic squamous cell carcinoma of the lung progressing after erlotinib/gefitinib (E/G) and chemotherapy: interim subset analysis from a phase III trial. J Clin Oncol 2012;30(Suppl):abstract 7558
   Google Scholar
• Regales L, Gong Y, Shen R, et al. Dual targeting of EGFR can overcome a major drug resistance mutation in mouse models of EGFR mutant lung cancer. The J Clin Invest 2009;119(10):3000-10
   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 2011;29(Suppl):abstract 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. Ann Oncol 2012;23(Suppl):abstract 12270
   Google Scholar
• Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_product_information/human/00280/WC500152392.pdf [Accessed on 29 December 2013]
   Google Scholar
• Available from: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/regist/reg_innov_dr-eng.pdf [Accessed on 16 February 2014]
   Google Scholar
• Grossi F, Gridelli C, Aita M, De Marinis F. Identifying an optimum treatment strategy for patients with advanced non-small cell lung cancer. Crit Rev Oncol Hematol 2008;67(1):16-26
   PubMedGoogle Scholar
• Grossi F, Rijavec E, Dal Bello MG, et al. The administration of gefitinib in patients with advanced non-small-cell lung cancer after the failure of erlotinib. Cancer Chemother Pharmacol 2012;69(6):1407-12
   PubMedGoogle Scholar
• Vasile E, Tibaldi C, Chella A, Falcone A. Erlotinib after failure of gefitinib in patients with advanced non-small cell lung cancer previously responding to gefitinib. J Thorac Oncol 2008;3(8):912-14
   PubMed Web of Science ®Google Scholar
• Genova C, Rijavec E, Truini A, et al. Pemetrexed for the treatment of non-small cell lung cancer. Expert Opin Pharmacother 2013;14(11):1545-58
   PubMed Web of Science ®Google Scholar
• Yang JC, Sequist L, O'Byrne K, et al. Epidermal growth factor receptor (EGFR)-mediated adverse events (AEs) in patients (pts) with EGFR mutation positive (EGFR M+) non-small cell lung cancer treated with afatinib. Eur J Cancer 2013;49(Suppl):abstract S190-Presented at the 38th Annual Congress of the European Society for Medical Oncology (ESMO); 27 September- 1 October2013; Amsterdam
   Google Scholar
• Takimoto T, Kijima T, Otani Y, et al. Polymorphisms of CYP2D6 gene and gefitinib-induced hepatotoxicity. Clin Lung Cancer 2013;14(5):502-7
   PubMed Web of Science ®Google Scholar
• Grossi F, Dal Bello G, Rijavec E, et al. Pretreatment evaluation of the T790M mutation and its correlation with the response to tyrosine kinase inhibitors (TKIS) or chemotherapy in advanced non-small cell lung cancer (NSCLC) patients with activated EGFR mutations. J Thorac Oncol 2013;8(Suppl):abstract O21.02-Presented at the 15th World Conference on Lung Cancer.; 27 October- 30 October 2013; Sidney
   Google Scholar
• Lopez-Rios F, Angulo B, Gomez B, et al. Comparison of molecular testing methods for the detection of EGFR-mutations in formalin-fixed paraffin-embedded tissue specimens of non-small cell lung cancer. J Clin Pathol 2013;66(5):381-5
   PubMed Web of Science ®Google Scholar