Crizotinib: an orphan drug for treating non-small-cell lung cancer

Bibliography

• Christensen JG, Zou HY, Arango ME, et al. Cytoreductive antitumor activity of PF-2341066, a novel inhibitor of anaplastic lymphoma kinase and c-Met, in experimental models of anaplastic large-cell lymphoma. Mol Cancer Ther 2007;6:3314-22
   PubMed Web of Science ®Google Scholar
• Roskoski R. The preclinical profile of crizotinib for the treatment of non-small-cell lung cancer and other neoplastic disorders. Expert Opin Drug Discov 2013;8:1165-79
   PubMed Web of Science ®Google Scholar
• Kwak L, Camidge D, Clark J, et al. Clinical activity observed in a phase I dose escalation trial of an oral c-met and ALK inhibitor, PF-02341066. J Clin Oncol 2009;27:15s
   Web of Science ®Google Scholar
• Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-703
   PubMed Web of Science ®Google Scholar
• Available from: www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.htm [Last accessed 15 June, 2015]
   Google Scholar
• Pfizer. Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI® (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer. Available from: www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_u_s_fda_breakthrough_therapy_designation_for_xalkori_crizotinib_for_the_treatment_of_patients_with_ros1_positive_non_small_cell_lung_cancer [Last accessed 15 June 2015]
   Google Scholar
• Vaishnavi A, Capelletti M, Le AT, et al. Oncogenic and drug-sensitive NTRK1 rearrangements in lung cancer. Nat Med 2013;19:1469-72
   PubMed Web of Science ®Google Scholar
• Malik SM, Maher VE, Bijwaard KE, et al. U.S. Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive. Clin Cancer Res 2014;20:2029-34
   PubMed Web of Science ®Google Scholar
• Pfizer Crizotinib US Package Insert. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2011/202570s000lbl.pdf [Last accessed 15 June 2015]
   Google Scholar
• Kurzrock R, Kantarjian HM, Druker BJ, Talpaz M. Philadelphia chromosome-positive leukemias: from basic mechanisms to molecular therapeutics. Ann Intern Med 2003;138:819-30
   PubMed Web of Science ®Google Scholar
• Stransky N, Cerami E, Schalm S, et al. The landscape of kinase fusions in cancer. Nat Commun 2014;5:4846
   PubMed Web of Science ®Google Scholar
• Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 2007;448:561-6
   PubMed Web of Science ®Google Scholar
• Gainor JF, Shaw AT. Novel Targets in Non-Small Cell Lung Cancer: ROS1 and RET Fusions. Oncologist 2013;18:865-75
   PubMed Web of Science ®Google Scholar
• Fernandez-Cuesta L, Plenker D, Osada H, et al. CD74-NRG1 Fusions in Lung Adenocarcinoma. Cancer Discov 2014;4:415-22
   PubMed Web of Science ®Google Scholar
• Shaw AT, Solomon B. Targeting anaplastic lymphoma kinase in lung cancer. Clin Cancer Res 2011;17:2081-6
   PubMed Web of Science ®Google Scholar
• Martelli MP, Sozzi G, Hernandez L, et al. EML4-ALK rearrangement in non-small cell lung cancer and non-tumor lung tissues. Am J Pathol 2009;174:661-70
   PubMed Web of Science ®Google Scholar
• Roskoski R. Anaplastic lymphoma kinase (ALK): structure, oncogenic activation, and pharmacological inhibition. Pharmacol Res 2013;68:68-94
   PubMed Web of Science ®Google Scholar
• Network CGAR. Comprehensive molecular profiling of lung adenocarcinoma. Nature 2014;511:543-50
   PubMed Web of Science ®Google Scholar
• Kasprzycka M, Marzec M, Liu X, et al. Nucleophosmin/anaplastic lymphoma kinase (NPM/ALK) oncoprotein induces the T regulatory cell phenotype by activating STAT3. Proc Natl Acad Sci USA 2006;103:9964-9
   PubMed Web of Science ®Google Scholar
• Camidge DR, Doebele RC. Treating ALK-positive lung cancer–early successes and future challenges. Nat Rev Clin Oncol 2012;9:268-77
   PubMed Web of Science ®Google Scholar
• Shaw AT, Yeap BY, Mino-Kenudson M, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J Clin Oncol 2009;27:4247-53
   PubMed Web of Science ®Google Scholar
• Wong DW, Leung EL, So KK, et al. The EML4-ALK fusion gene is involved in various histologic types of lung cancers from nonsmokers with wild-type EGFR and KRAS. Cancer 2009;115:1723-33
   PubMed Web of Science ®Google Scholar
• Shaw AT, Varghese AM, Solomon BJ, et al. Pemetrexed-based chemotherapy in patients with advanced, ALK-positive non-small cell lung cancer. Ann Oncol 2013;24:59-66
   PubMed Web of Science ®Google Scholar
• Buccoliero AM, Ghionzoli M, Castiglione F, et al. Inflammatory myofibroblastic tumor: clinical, morphological, immunohistochemical and molecular features of a pediatric case. Pathol Res Pract 2014;210:1152-5
   PubMed Web of Science ®Google Scholar
• Aisner DL, Nguyen TT, Paskulin DD, et al. ROS1 and ALK fusions in colorectal cancer, with evidence of intratumoral heterogeneity for molecular drivers. Mol Cancer Res 2014;12:111-18
   PubMed Web of Science ®Google Scholar
• Drexler HG, Gignac SM, von Wasielewski R, et al. Pathobiology of NPM-ALK and variant fusion genes in anaplastic large cell lymphoma and other lymphomas. Leukemia 2000;14:1533-59
   PubMed Web of Science ®Google Scholar
• Schönherr C, Ruuth K, Yamazaki Y, et al. Activating ALK mutations found in neuroblastoma are inhibited by Crizotinib and NVP-TAE684. Biochem J 2011;440:405-13
   PubMed Web of Science ®Google Scholar
• Di Renzo MF, Narsimhan RP, Olivero M, et al. Expression of the Met/HGF receptor in normal and neoplastic human tissues. Oncogene 1991;6:1997-2003
   PubMed Web of Science ®Google Scholar
• Sonnenberg E, Weidner KM, Birchmeier C. Expression of the met-receptor and its ligand, HGF-SF during mouse embryogenesis. EXS 1993;65:381-94
   PubMedGoogle Scholar
• Camidge DR, Pao W, Sequist LV. Acquired resistance to TKIs in solid tumours: learning from lung cancer. Nat Rev Clin Oncol 2014;11:473-81
   PubMed Web of Science ®Google Scholar
• Ou SH, Tan J, Yen Y, Soo RA. ROS1 as a ‘druggable’ receptor tyrosine kinase: lessons learned from inhibiting the ALK pathway. Expert Rev Anticancer Ther 2012;12:447-56
   PubMed Web of Science ®Google Scholar
• Stumpfova M, Jänne PA. Zeroing in on ROS1 rearrangements in non-small cell lung cancer. Clin Cancer Res 2012;18:4222-4
   PubMed Web of Science ®Google Scholar
• Bergethon K, Shaw AT, Ou SH, et al. ROS1 rearrangements define a unique molecular class of lung cancers. J Clin Oncol 2012;30:863-70
   PubMed Web of Science ®Google Scholar
• Camidge DR, Bang YJ, Kwak EL, et al. Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol 2012;13:1011-19
   PubMed Web of Science ®Google Scholar
• Kim D, Ahn M, Shi Y, et al. Results of a global phase II study with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC). J Clin Oncol 2012;30
   Web of Science ®Google Scholar
• Ou SH, Jänne PA, Bartlett CH, et al. Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC. Ann Oncol 2014;25:415-22
   PubMed Web of Science ®Google Scholar
• Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013;368:2385-94
   PubMed Web of Science ®Google Scholar
• Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 2014;371:2167-77
   PubMed Web of Science ®Google Scholar
• McDermott U, Iafrate AJ, Gray NS, et al. Genomic alterations of anaplastic lymphoma kinase may sensitize tumors to anaplastic lymphoma kinase inhibitors. Cancer Res 2008;68:3389-95
   PubMed Web of Science ®Google Scholar
• Mazières J, Zalcman G, Crinò L, et al. Crizotinib therapy for advanced lung adenocarcinoma and a ROS1 rearrangement: results from the EUROS1 cohort. J Clin Oncol 2015;33:992-9
   PubMed Web of Science ®Google Scholar
• Shaw AT, Ou SH, Bang YJ, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med 2014;371:1963-71
   PubMed Web of Science ®Google Scholar
• Ou SH, Kwak EL, Siwak-Tapp C, et al. Activity of crizotinib (PF02341066), a dual mesenchymal-epithelial transition (MET) and anaplastic lymphoma kinase (ALK) inhibitor, in a non-small cell lung cancer patient with de novo MET amplification. J Thorac Oncol 2011;6:942-6
   PubMed Web of Science ®Google Scholar
• Camidge DR, Ou SHI, Shapiro G, et al. Efficacy and safety of crizotinib in patients with advanced c-MET-amplified non-small cell lung cancer (NSCLC). J Clin Oncol 2014;32:5s
   PubMed Web of Science ®Google Scholar
• Waqar SN, Morgensztern D, Sehn J. MET Mutation Associated with Responsiveness to Crizotinib. J Thorac Oncol 2015;10:e29-31
   PubMed Web of Science ®Google Scholar
• Goździk-Spychalska J, Szyszka-Barth K, Spychalski L, et al. C-MET inhibitors in the treatment of lung cancer. Curr Treat Options Oncol 2014;15:670-82
   PubMed Web of Science ®Google Scholar
• Sequist LV, von Pawel J, Garmey EG, et al. Randomized phase II study of erlotinib plus tivantinib versus erlotinib plus placebo in previously treated non-small-cell lung cancer. J Clin Oncol 2011;29:3307-15
   PubMed Web of Science ®Google Scholar
• Rolfo C, Van Der Steen N, Pauwels P, Cappuzzo F. Onartuzumab in lung cancer: the fall of Icarus? Expert Rev Anticancer Ther 2015;15:487-9
   PubMed Web of Science ®Google Scholar
• Tong W, Azada M, Ou S. Should crizotinib be dosed to sinus bradycardia (SB) (HR < 55)- A single institution, retrospective analysis of heart rate (HR) changes and tumor response in crizotinib treated NSCLC patients. J Clin Oncol 2012;30:suppl; abstr e18140
   Google Scholar
• Weickhardt AJ, Rothman MS, Salian-Mehta S, et al. Rapid-onset hypogonadism secondary to crizotinib use in men with metastatic nonsmall cell lung cancer. Cancer 2012;118:5302-9
   PubMed Web of Science ®Google Scholar
• Roberts PJ. Clinical use of crizotinib for the treatment of non-small cell lung cancer. Biologics 2013;7:91-101
   PubMedGoogle Scholar
• Choi YL, Soda M, Yamashita Y, et al. EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors. N Engl J Med 2010;363:1734-9
   PubMed Web of Science ®Google Scholar
• Katayama R, Shaw AT, Khan TM, et al. Mechanisms of acquired crizotinib resistance in ALK-rearranged lung Cancers. Sci Transl Med 2012;4:120ra17
   PubMed Web of Science ®Google Scholar
• Shaw AT, Engelman JA. ALK in lung cancer: past, present, and future. J Clin Oncol 2013;31:1105-11
   PubMed Web of Science ®Google Scholar
• Sasaki T, Koivunen J, Ogino A, et al. A novel ALK secondary mutation and EGFR signaling cause resistance to ALK kinase inhibitors. Cancer Res 2011;71:6051-60
   PubMed Web of Science ®Google Scholar
• Doebele RC, Pilling AB, Aisner DL, et al. Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer. Clin Cancer Res 2012;18:1472-82
   PubMed Web of Science ®Google Scholar
• Sakamoto H, Tsukaguchi T, Hiroshima S, et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell 2011;19:679-90
   PubMed Web of Science ®Google Scholar
• Friboulet L, Li N, Katayama R, et al. The ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. Cancer Discov 2014;4:662-73
   PubMed Web of Science ®Google Scholar
• Shaw AT, Kim DW, Mehra R, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med 2014;370:1189-97
   PubMed Web of Science ®Google Scholar
• Gadgeel SM, Gandhi L, Riely GJ, et al. Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol 2014;15:1119-28
   PubMed Web of Science ®Google Scholar
• Mossé YP, Lim MS, Voss SD, et al. Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: a Children’s Oncology Group phase 1 consortium study. Lancet Oncol 2013;14:472-80
   PubMed Web of Science ®Google Scholar
• Lennerz JK, Kwak EL, Ackerman A, et al. MET amplification identifies a small and aggressive subgroup of esophagogastric adenocarcinoma with evidence of responsiveness to crizotinib. J Clin Oncol 2011;29:4803-10
   PubMed Web of Science ®Google Scholar
• Zhou Y, Zhao C, Gery S, et al. Off-target effects of c-MET inhibitors on thyroid cancer cells. Mol Cancer Ther 2014;13:134-43
   PubMed Web of Science ®Google Scholar
• Bresler SC, Wood AC, Haglund EA, et al. Differential inhibitor sensitivity of anaplastic lymphoma kinase variants found in neuroblastoma. Sci Transl Med 2011;3:108ra14
   Web of Science ®Google Scholar
• Iyer G, Hanrahan AJ, Milowsky MI, et al. Genome sequencing identifies a basis for everolimus sensitivity. Science 2012;338:221
   PubMed Web of Science ®Google Scholar
• Devarakonda S, Morgensztern D, Govindan R. Molecularly Targeted Therapies in Locally Advanced Non-Small-Cell Lung Cancer. Clin Lung Cancer 2013. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med 2015; Epub ahaead of print
   PubMed Web of Science ®Google Scholar
• Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 2015;372:2018-28
   PubMed Web of Science ®Google Scholar
• Spranger S, Bao R, Gajewski TF. Melanoma-intrinsic β-catenin signalling prevents anti-tumour immunity. Nature 2015; Epub ahead of print
   PubMed Web of Science ®Google Scholar
• Kim D, Ahn M, Yang P. Updated results of a global phase II study with crizotinib in ALK-positive non-small cell lung cancer (NSCLC). Ann Oncol 2012;23(Supppl 9:ix400-ix446
   Google Scholar