Neratinib: an oral, irreversible dual EGFR/HER2 inhibitor for breast and non-small cell lung cancer

Bibliography

• Pazdur R, Wagman LD, Camphausen KA, Hoskins WJ, editors, Cancer management: a multidisciplinary approach. 11th edition. CMP Medica; 2008
   Google Scholar
• Slamon DJ, Godolphin W, Jones LA, Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989;244:707-12
   PubMed Web of Science ®Google Scholar
• Romond EH, Perez EA, Bryant J, Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353:1673-84
   PubMed Web of Science ®Google Scholar
• Perez EA, Romond EH, Suman VJ, Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER2-positive breast cancer [abstract]. J Clin Oncol 2007;25:6s. Available from: www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD & vmview=abst_detail_view & confID=47 & abstractID=35229 [Last accessed 18 May 2009]
   PubMed Web of Science ®Google Scholar
• Cobleigh MA, Vogel CL, Tripathy D, Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999;17:2639-48
   PubMed Web of Science ®Google Scholar
• Seidman AD, Fornier MN, Esteva FJ, Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol 2001;19:2587-95
   PubMed Web of Science ®Google Scholar
• Mackey JR, Kaufman B, Clemens M, Trastuzumab prolongs progression-free survival in hormone-dependent and HER2-positive metastatic breast cancer [abstract]. Data presented at the 29th annual San Antonio Breast Cancer Symposium, December 14, 2006. Available from: www.abstracts2view.com/sabcs06/view.php?nu=SABCS06L_665 [Last accessed 18 May 2009]
   Google Scholar
• Geyer CE, Forster J, Lindquist D, Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355:2733-43
   PubMed Web of Science ®Google Scholar
• Landis SH, Murray T, Bolden S, Cancer Statistics 1999. CA Cancer J Clin 1999;49:8-31
   PubMed Web of Science ®Google Scholar
• Salomon DS, Brandt R, Ciardiello F, Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995;19:183-232
   PubMed Web of Science ®Google Scholar
• Silvestri GA, Rivera MP. Targeted therapy for the treatment of advanced non-small cell lung cancer. Chest 2005;128:3975-84
   PubMed Web of Science ®Google Scholar
• Bailey R, Kris M, Wolf M, Tumor EGFR membrane staining is not clinically relevant for predicting response in patients receiving gefitinib (‘Iressa’, ZD1839) monotherapy for pretreated advanced non-small-cell lung cancer: IDEAL 1 and 2. Proc Am Assoc Cancer Res 2003;44(2nd edition):1362
   Google Scholar
• Bailey LR, Janas M, Schmidt K, Evaluation of epidermal growth factor receptor (EGFR) as a predictive marker in patients with non-small-cell lung cancer (NSCLC) receiving first-line gefitinib combined with platinum-based chemotherapy. Proc Am Soc Clin Oncol 2004;23:618
   Google Scholar
• Lynch TJ, Bell DW, Sordella R, Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004;350:2129-39
   PubMed Web of Science ®Google Scholar
• Paez JG, Janne PA, Lee JC, EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497-500
   PubMed Web of Science ®Google Scholar
• Pao W, Miller V, Zakowski M, EGF receptor gene mutations are common in lung cancers from “never smokers” and are associated with sensitivity of tumors to gefitinib and erlotinib. Proc Natl Acad Sci USA 2004;101:13306-11
   PubMed Web of Science ®Google Scholar
• Shepherd FA, Pereira J, Ciuleanu TE, Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 2005;353:123-32
   PubMed Web of Science ®Google Scholar
• Harari PM, Allen GW, Bonner JA. Biology of interactions: antiepidermal growth factor receptor agents. J Clin Oncol 2007;25:4057-65
   PubMed Web of Science ®Google Scholar
• Bonner JA, Harari PM, Giralt J, Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 2006;354:567-78
   PubMed Web of Science ®Google Scholar
• Cunningham D, Humblet Y, Siena S, Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004;351:337-45
   PubMed Web of Science ®Google Scholar
• Van Cutsem E, Peeters M, Siena S, Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007;25(13):1658-64
   PubMed Web of Science ®Google Scholar
• Pirker R, Pereira JR, Szczesna A, Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label phase III randomized trial. Lancet 2009;373:1525-31
   Google Scholar
• Sequist LV. Second-generation epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer. Oncologist 2007;12:325-30
   PubMed Web of Science ®Google Scholar
• Ji H, Li D, Chen L, The impact of human EGFR kinase domain mutations on lung tumorigenesis and in vivo sensitivity to EGFR-targeted therapies. Cancer Cell 2006;9:485-95
   PubMed Web of Science ®Google Scholar
• Riley GJ. Second-generation epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer. J Thoracic Oncol 2008;3(6):S146-9
   PubMed Web of Science ®Google Scholar
• Yun C, Mengwasser KE, Toms AV, 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, Shimamura T, Ji H, Bronchial and peripheral murine lung carcinomas induced by T790M-L858R mutant EGFR respond to HKI-272 and rapamycin combination therapy. Cancer Cell 2007;12:81-93
   PubMed Web of Science ®Google Scholar
• Kwak EL, Sordella R, Bell DW, Irreversible inhibitors of the EGF receptor may circumvent acquired resistance to gefitinib. Proc Natl Acad Sci USA 2005;102(21):7665-70
   PubMed Web of Science ®Google Scholar
• Ji H, Zhao X, Yuza Y, Epidermal growth factor receptor variant III mutations in lung tumorigenesis and sensitivity to tyrosine kinase inhibitors. Proc Natl Acad Sci USA 2006;103(20):7817-22
   PubMed Web of Science ®Google Scholar
• Shigematsu H, Takahashi T, Nomura M, Somatic mutations of the HER2 kinase domain in lung adenocarcinomas. Cancer Res 2005;65:1642-6
   PubMed Web of Science ®Google Scholar
• Stephens P, Hunter C, Bignell G, Lung cancer: intragenic ERBB2 kinase mutations in tumors. Nature 2004;431:525-6
   PubMed Web of Science ®Google Scholar
• Minami Y, Shimamura T, Shah K, The major lung cancer-derived mutants of ERBB2 are oncogenic and are associated with sensitivity to the irreversible EGFR/ERBB2 inhibitor HKI-272. Oncogene 2007;26:5023-7
   PubMed Web of Science ®Google Scholar
• Slamon DJ, Clark GM, Wong SG, Human breast cancer: correlation of relapse and survival with amplification of the HER2/neu oncogene. Science 1987;235:177-82
   PubMed Web of Science ®Google Scholar
• Bilancia D, Rosati G, Dinota A, Lapatinib in breast cancer. Ann Oncol 2007;18(S6):vi26-30
   PubMedGoogle Scholar
• Pal SK, Pegram M. HER2 targeted therapy in breast cancer beyond herceptin. Rev Endocr Metab Disord 2007;8:269-77
   PubMed Web of Science ®Google Scholar
• Vogel CL, Cobleigh MA, Tripathy D, Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002;20:719-26
   PubMed Web of Science ®Google Scholar
• Valabrega G, Montemurro F, Aglietta M. Trastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancer. Ann Oncol 2007;18:977-84
   PubMed Web of Science ®Google Scholar
• Xia W, Liu LH, Ho P, Truncated ErbB2 receptor (p95ErbB2) is regulated by heregulin through heterodimer formation with ErbB3 yet remains sensitive to the dual EGFR/ErbB2 kinase inhibitor GW572016. Oncogene 2004;23:646-53
   PubMed Web of Science ®Google Scholar
• Rabindran SK, Discafani CM, Rosfjord EC, Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase. Cancer Res 2004;64:3958-65
   PubMed Web of Science ®Google Scholar
• Wissner A, Mansour TS. The development of HKI-272 and related compounds for the treatment of cancer. Arch Pharm Chem Life Sci 2008;341:465-77
   PubMed Web of Science ®Google Scholar
• Tsou H, Elsebe GO, Hallett WA, Optimization of 6,7-disubstituted-4-(arylamino) quinoline-3-carbonitriles as orally active, irreversible inhibitors of human epidermal growth factor receptor-2 kinase activity. J Med Chem 2005;48:1107-31
   PubMed Web of Science ®Google Scholar
• Wissner A, Overbeek E, Reich MF, Synthesis and structure-activity relationships of 6,7-disubstituted 4-anilino-quinoline-3-carbonitriles. The design of orally active irreversible inhibitor of the tyrosine kinase activity of the epidermal growth factor receptor (EGFR) and the human epidermal growth factor receptor-2 (HER-2). J Med Chem 2003;46:49-63
   PubMed Web of Science ®Google Scholar
• Wong KK, Francasso PM, Bukowski RM, A phase I study with neratinib (HKI-272), an irreversible Pan ErbB receptor tyrosine kinase inhibitor, in patients with solid tumors. Clin Cancer Res 2009;15(7):2552-8
   PubMed Web of Science ®Google Scholar
• Ito Y, Hatake K, Takahashi S, Tolerability and safety of oral neratinib (HKI-272) in Japanese patients with advanced solid tumors. J Clin Oncol 2009;27(Suppl): abstract e14505
   Google Scholar
• Burstein H, Awada A, Badwe R, HKI-272, an irreversible pan erbB receptor tyrosine kinase inhibitor: preliminary phase II results in patients with advanced breast cancer. Presented at the 2007 San Antonio Breast Cancer Symposium; poster 6061
   Google Scholar
• Burstein HJ, Sun Y, Tan AR, Neratinib (HKI-272), an irreversible pan erbB receptor tyrosine kinase inhibitor: phase 2 results in patients with advanced HER2+ breast cancer. Presented at the 2008 San Antonio Breast Cancer Symposium; abstract 37
   Google Scholar
• Chow L, Jiang Z, Epstein R, Safety and efficacy of neratinib (HKI-272) in combination with paclitaxel in patients with solid tumors. J Clin Oncol 2009;27(15s): abstract 3557
   Google Scholar
• Limentani SA, Awada A, Dirix L, Safety and efficacy of neratinib (HKI-272) in combination with vinorelbine in patients with solid tumors. J Clin Oncol 2009;27(Suppl): abstract e14554
   PubMedGoogle Scholar
• Swaby R, Blackwell K, Jiang Z, Neratinib in combination with trastuzumab for the treatment of advanced breast cancer: A phase I/II study. J Clin Oncol 2009;27(15s): abstract 1004
   Google Scholar
• Herbst RS, Sun Y, Korfee S, Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small cell lung cancer (NSCLC): A randomized, double-blind phase III trial (ZODIAC). J Clin Oncol 2009;27(18s): abstract CRA8003
   Google Scholar
• Gelmon KA, Fumoleau P, Verma S, Results of a phase II trial of trastuzumab (H) and pertuzumab (P) in patients (pts) with HER2-positive metastatic breast cancer (MBC) who had progressed during trastuzumab therapy. J Clin Oncol 2008;26(Suppl): abstract 1026
   Google Scholar
• Cortes J, Baselga J, Petrella T, Pertuzumab monotherapy following trastuzumab-based treatment: Activity and tolerability in patients with advanced HER2-positive breast cancer. J Clin Oncol 2009;27(15s): abstract 1022
   Google Scholar