Efficacy of crizotinib inhibiting specific molecular pathways in non-small-cell lung carcinoma

References

• Ettinger DS, Bepler G, Bueno R, et al. Non-small cell lung cancer clinical practice guidelines in oncology. J Natl Compr Canc Netw 2006;4(6):548-82
   PubMedGoogle Scholar
• Brambilla E, Travis WD, Colby TV, et al. The new World Health Organization classification of lung tumours. Eur Respir J 2001;18(6):1059-68
   PubMed Web of Science ®Google Scholar
• Edwards BK, Brown ML, Wingo PA, et al. Annual report to the nation on the status of cancer, 1975-2002, featuring population-based trends in cancer treatment. J Natl Cancer Inst 2005;97(19):1407-27
   PubMed Web of Science ®Google Scholar
• McKay MM, Morrison DK. Integrating signals from RTKs to ERK/MAPK. Oncogene 2007;26(22):3113-21
   PubMed Web of Science ®Google Scholar
• Wasik MA, Zhang Q, Marzec M, et al. Anaplastic lymphoma kinase (ALK)-induced malignancies: novel mechanisms of cell transformation and potential therapeutic approaches. Semin Oncol 2009;36(2 Suppl 1):S27-35
   Google Scholar
• Chiarle R, Voena C, Ambrogio C, et al. The anaplastic lymphoma kinase in the pathogenesis of cancer. Nat Rev Cancer 2008;8(1):11-23
   PubMed Web of Science ®Google Scholar
• Morris SW, Kirstein MN, Valentine MB, et al. Fusion of a kinase gene, ALK, to a nucleolar protein gene, NPM, in non-Hodgkin’s lymphoma. Science 1994;263(5151):1281-4
   PubMed Web of Science ®Google Scholar
• Amin HM, Lai R. Pathobiology of ALK+ anaplastic large-cell lymphoma. Blood 2007;110(7):2259-67
   PubMed Web of Science ®Google Scholar
• Chen Y, Takita J, Choi YL, et al. Oncogenic mutations of ALK kinase in neuroblastoma. Nature 2008;455(7215):971-4
   PubMed Web of Science ®Google Scholar
• Sharma SV, Settleman J. Oncogene addiction: setting the stage for molecularly targeted cancer therapy. Genes Dev 2007;21(24):3214-31
   PubMed Web of Science ®Google Scholar
• Piva R, Chiarle R, Manazza AD, et al. Ablation of oncogenic ALK is a viable therapeutic approach for anaplastic large-cell lymphomas. Blood 2006;107(2):689-97
   PubMed Web of Science ®Google Scholar
• Houtman SH, Rutteman M, De Zeeuw CI, French PJ. Echinoderm microtubule-associated protein like protein 4, a member of the echinoderm microtubule-associated protein family, stabilizes microtubules. Neuroscience 2007;144(4):1373-82
   PubMedGoogle Scholar
• Choi YL, Takeuchi K, Soda M, et al. Identification of novel isoforms of the EML4-ALK transforming gene in non-small cell lung cancer. Cancer Res 2008;68(13):4971-6
   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(7153):561-6
   PubMed Web of Science ®Google Scholar
• Takeuchi K, Choi YL, Soda M, et al. Multiplex reverse transcription-PCR screening for EML4-ALK fusion transcripts. Clin Cancer Res 2008;14(20):6618-24
   PubMed Web of Science ®Google Scholar
• Takeuchi K, Choi YL, Togashi Y, et al. KIF5B-ALK, a novel fusion oncokinase identified by an immunohistochemistry-based diagnostic system for ALK-positive lung cancer. Clin Cancer Res 2009;15(9):3143-9
   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(8):1723-33
   PubMed Web of Science ®Google Scholar
• Perner S, Wagner PL, Demichelis F, et al. EML4-ALK fusion lung cancer: a rare acquired event. Neoplasia 2008;10(3):298-302
   PubMed Web of Science ®Google Scholar
• Inamura K, Takeuchi K, Togashi Y, et al. EML4-ALK fusion is linked to histological characteristics in a subset of lung cancers. J Thorac Oncol 2008;3(1):13-17
   PubMed Web of Science ®Google Scholar
• Shinmura K, Kageyama S, Tao H, et al. EML4-ALK fusion transcripts, but no NPM-, TPM3-, CLTC-, ATIC-, or TFG-ALK fusion transcripts, in non-small cell lung carcinomas. Lung Cancer 2008;61(2):163-9
   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(26):4247-53
   PubMed Web of Science ®Google Scholar
• Zhao N, Zheng SY, Yang JJ et. al. Lung adenocarcinoma harboring concomitant EGFR mutation and EML4-ALK fusion that benefits from three kinds of tyrosine kinase inhibitors: a case report and literature review. Clin Lung Cancer 2015;16(2):e5-9
   Google Scholar
• Fukuyoshi Y, Inoue H, Kita Y, et al. EML4-ALK fusion transcript is not found in gastrointestinal and breast cancers. Br J Cancer 2008;98(9):1536-9
   PubMedGoogle Scholar
• Shaw AT, Yeap B, Costa DB, et al. Prognostic versus predictive value of EML4-ALK translocation in metastatic non-small cell lung cancer. J Clin Oncol Meeting Abstracts 2010;28(15 suppl):7606
   Google Scholar
• Li R, Morris SW. Development of anaplastic lymphoma kinase (ALK) small-molecule inhibitors for cancer therapy. Med Res Rev 2008;28(3):372-412
   PubMed Web of Science ®Google Scholar
• Gunby RH, Ahmed S, Sottocornola R, et al. Structural insights into the ATP binding pocket of the anaplastic lymphoma kinase by site-directed mutagenesis, inhibitor binding analysis, and homology modeling. J Med Chem 2006;49(19):5759-68
   PubMedGoogle Scholar
• Zou HY, Li Q, Lee JH, et al. An orally available small-molecule inhibitor of c-Met, PF-2341066, exhibits cytoreductive antitumor efficacy through antiproliferative and antiangiogenic mechanisms. Cancer Res 2007;67(9):4408-17
   PubMed Web of Science ®Google Scholar
• 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(12 Pt 1):3314-22
   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(9):3389-95
   PubMed Web of Science ®Google Scholar
• Kwak EL, Camidge DR, 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 Meeting Abstracts 2009;27(15S):3509
   Google Scholar
• A Study Of Oral PF-02341066, A c-Met/hepatocyte growth factor tyrosine kinase inhibitor, in patients with advanced cancer. Available from: https://clinicaltrials.gov/ct2/results?term=NCT00585195&Search=Search
   Google Scholar
• An investigational drug, PF-02341066, is being studied in patients with advanced non-small cell lung cancer with a specific gene profile involving the anaplastic lymphoma kinase (ALK) Gene. Available from: https://clinicaltrials.gov/ct2/results?term=NCT00932451&Search=Search
   Google Scholar
• Bang Y, Kwak EL, Shaw AT, et al. Clinical activity of the oral ALK inhibitor PF-02341066 in ALK-positive patients with non-small cell lung cancer (NSCLC). J Clin Oncol Meeting Abstracts 2010;28(18 suppl):3
   PubMedGoogle 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(18):1693-703
   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(10):1011-19
   PubMed Web of Science ®Google Scholar
• Kim D-W, Ahn M-J, Shi Y, et al. Results of a global phase II study with crizotinib in advanced ALK-positive non-small celllung cancer (NSCLC). J Clin Oncol 2012;30(suppl):abstr 7533
   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(25):2385-94
   PubMed Web of Science ®Google Scholar
• An investigational drug, PF-02341066 is being studied versus standard of care in patients with advanced non-small cell lung cancer with a specific gene profile involving the anaplastic lymphoma kinase (ALK) Gene. Available from: https://clinicaltrials.gov/ct2/results?term=NCT00932893&Search=Search
   Google Scholar
• Shaw AT, Yeap BY, Solomon BJ, et al. Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis. Lancet Oncology 2011;12(11):1004-12
   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(23):2167-77
   PubMed Web of Science ®Google Scholar
• A clinical trial testing the efficacy of crizotinib versus standard chemotherapy pemetrexed plus cisplatin or carboplatin in patients with alk positive non squamous cancer of the lung. Available from: https://clinicaltrials.gov/ct2/results?term=NCT01154140&Search=Search
   Google Scholar
• Matsushime H, Wang LH, Shibuya M. Human c-ros-1 gene homologous to the v-ros sequence of UR2 sarcoma virus encodes for a transmembrane receptorlike molecule. Mol Cell Biol 1986;6(8):3000-4
   PubMed Web of Science ®Google Scholar
• Robinson DR, Wu YM, Lin SF. The protein tyrosine kinase family of the human genome. Oncogene 2000;19(49):5548-57
   PubMed Web of Science ®Google Scholar
• Acquaviva J, Wong R, Charest A. The multifaceted roles of the receptor tyrosine kinase ROS in development and cancer. Biochim Biophys Acta BBARev Cancer 2009;1795(1):37-52
   PubMed Web of Science ®Google Scholar
• Davies KD, Doebele RC. Molecular pathways: ROS1 fusion proteins in cancer. Clin Cancer Res 2013;19(15):4040-5
   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(8):863-70
   PubMed Web of Science ®Google Scholar
• Shaw AT, Solomon BJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med 2015;372(7):683-4
   PubMedGoogle Scholar
• Porter J. Small molecule c-Met kinase inhibitors: a review of recent patents. Expert Opin Ther Pat 2010;20(2):159-77
   PubMed Web of Science ®Google Scholar
• Tanizaki J, Okamoto I, Okamoto K, et al. MET tyrosine kinase inhibitor crizotinib (PF-02341066) shows differential antitumor effects in non-small cell lung cancer according to MET alterations. J Thorac Oncol 2011;6(10):1624-31
   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(5):942-6
   PubMed Web of Science ®Google Scholar
• Schwab R, Petak I, Kollar M, et al. Major partial response to crizotinib, a dual MET/ALK inhibitor, in a squamous cell lung (SCC) carcinoma patient with de novo c-MET amplification in the absence of ALK rearrangement. Lung Cancer 2014;83(1):109-11
   PubMed Web of Science ®Google Scholar
• Camidge DR, Ou SI, Otterson GA, 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):Abstract # 8001
   Google Scholar
• Djalalov S, Beca J, Hoch JS, et al. Cost effectiveness of EML4-ALK fusion testing and first-line crizotinib treatment for patients with advanced ALK-positive non-small-cell lung cancer. J Clin Oncol 2014;32(10):1012-19
   PubMed Web of Science ®Google Scholar
• Atherly AJ, Camidge DR. The cost-effectiveness of screening lung cancer patients for targeted drug sensitivity markers. Br J Cancer 2012;106(6):1100-6
   PubMed Web of Science ®Google Scholar
• FDA. 2013
   Google Scholar
• UMA, European Medicine Agency, Committee for Medicinal Products for Human Use (CHMP). CHMP assessment report :Xalkori. International non-proprietary name: crizotinib. Procedure no. EMEA/H/C/002489. 2012
   Google Scholar
• NCCN, National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines): non-small cell lung cancer. 2013 (Version 2)
   Google Scholar
• Reck M, Popat S, Reinmuth N, et al. Metastatic non-sma ll-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up Ann Oncol 2014;25(Suppl 3):iii27-39
   PubMed Web of Science ®Google Scholar
• Leighl NB, Rekhtman N, Biermann WA, et al. Molecular testing for selection of patients with lung cancer for epidermal growth factor receptor and anaplastic lymphoma kinase tyrosine kinase inhibitors: American society of clinical oncology endorsement of the college of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Guideline. J Clin Oncol 2014;32: 32 3673-9
   PubMed Web of Science ®Google Scholar
• Nitta H, Tsuta K, Yoshida A, et al. New methods for ALK status diagnosis in non-small-cell lung cancer: an improved ALK immunohistochemical assay and a new, Brightfield, dual ALK IHC-in situ hybridization assay. J Thorac Oncol 2013;8(8):1019-31
   PubMed Web of Science ®Google Scholar
• Sholl LM, Weremowicz S, Gray SW, et al. Combined use of ALK immunohistochemistry and FISH for optimal detection of ALK-rearranged lung adenocarcinomas. J Thorac Oncol 2013;8(3):322-8
   PubMed Web of Science ®Google Scholar
• Jurmeister P, Lenze D, Berg E, et al. Parallel screening for ALK, MET and ROS1 alterations in non-small cell lung cancer with implications for daily routine testing. Lung Cancer 2015;87(2):122-9
   PubMedGoogle Scholar
• Gambacorti Passerini C, Farina F, Stasia A, et al. Crizotinib in advanced, chemoresistant anaplastic lymphoma kinase-positive lymphoma patients. J Natl Cancer Inst 2014;106(2):djt378
   PubMedGoogle Scholar
• Puig de la Bellacasa R, Karachaliou N, Estrada-Tejedor R, et al. ALK and ROS1 as a joint target for the treatment of lung cancer. a review. Transl Lung Cancer 2013;2:72-86
   PubMedGoogle 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(6):662-73
   PubMed Web of Science ®Google Scholar
• Ou S. Safety and efficacy analysis of RO5424802/CH5424802 in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) patients who have failed crizotinib in a dose-finding phase I study (AF-002JG, NCT01588028). Eur Cancer Cong 2013;abstract 44 LBA
   Google Scholar
• Seto T, Kiura K, Nishio M, et al. CH5424802 (RO5424802) for patients with ALK-rearranged advanced non-small-cell lung cancer (AF-001JP study): a single-arm, open-label, phase 1-2 study. Lancet Oncol 2013;14(7):590-8
   PubMed Web of Science ®Google Scholar
• Camidge DR, Bazhenova L, Salgia R, et al. Updated results of a first-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies. Eur Soc Med Oncol Cong 2013;abstract 3401
   Google Scholar
• Zhang S, Wang F, Keats J, et al. AP26113, a potent ALK inhibitor, overcomes mutations in EML4-ALK that confer resistance to PF-02341066 (PF1066). Proc Am Assoc Cancer Res 2010;51:Abstract LB-298
   Google Scholar
• Mori M, Ueno Y, Konagai S, et al. The selective anaplastic lymphoma receptor tyrosine kinase inhibitor ASP3026 Induces tumor regression and prolongs survival in non-small cell lung cancer model mice. Mol Cancer Ther 2014;13(2):329-40
   PubMed Web of Science ®Google Scholar
• Weiss G, Sachdev JC, Infante JR, et al. TSR-011: A potent inhibitor of ALK with activity in crizotinib-resistant tumor models in phase 1-2 development for ALK+ NSCLC. Eur Soc Med Oncol Cong 2013;abstract P417
   Google Scholar
• De Braud FG, Pilla L, Niger M, et al. Phase l open label, dose escalation study of RXDX101, an oral pan-trk, ROS1, and ALK inhibitor, in patients with advanced solid tumors with relevant molecular altration. J Clin Oncol 2014;32(15 suppl):ASCO Abstract 2502
   Google Scholar
• Lovly CM, Heuckmann JM, de Stanchina E, et al. Insights into ALK-Driven cancers revealed through development of novel ALK tyrosine kinase inhibitors. Cancer Res 2011;71(14):4920-31
   PubMed Web of Science ®Google Scholar
• Horn L, Infante JR, Blumenschein GR, et al. A phase I/II trial of X-396, a novel ALK inhibitor, in patients with advanced solid tumors. J Clin Oncol 2014;32(15 suppl):ASCO abstract 8030
   Google Scholar
• LDK378 versus chemotherapy in previously untreated patients with alk rearranged non-small cell lung cancer. Available from: https://clinicaltrials.gov/ct2/results?term=NCT01828099&Search=Search
   Google Scholar
• LDK378 versus chemotherapy in alk rearranged (alk positive) patients previously treated with chemotherapy (platinum doublet) and crizotinib. Available from: https://clinicaltrials.gov/ct2/results?term=NCT01828112&Search=Search
   Google Scholar
• Okimoto RA, Bivona TG. Recent advances in personalized lung cancer medicine. Per Med 2014;11(3):309-21
   PubMedGoogle Scholar
• A Study of CH5424802/RO5424802 in patients with alk-rearranged non-small cell lung cancer. Available from: https://clinicaltrials.gov/ct2/results?term=NCT01871805&Search=Search
   Google Scholar
• Crizotinib in treating young patients with relapsed or refractory solid tumors or anaplastic large cell lymphoma. Available from: https://clinicaltrials.gov/ct2/results?term=NCT00939770&Search=Search
   Google Scholar
• Crizotinib in combination with enzalutamide in metastatic castration-resistant prostate cancer. Available from: https://clinicaltrials.gov/ct2/results?term=NCT02207504&Search=Search
   Google Scholar
• Adjuvant crizotinib in high-risk uveal melanoma following definitive therapy. Available from: https://clinicaltrials.gov/ct2/results?term=NCT02223819&Search=Search
   Google Scholar
• Study to evaluate safety and activity of crizotinib with temozolomide and radiotherapy in newly diagnosed glioblastoma. Available from: https://clinicaltrials.gov/ct2/results?term=NCT02270034&Search=Search
   Google Scholar
• Study of the combination of crizotinib and dasatinib in pediatric research participants with diffuse pontine glioma (DIPG) and high-grade glioma (HGG). Available from: https://clinicaltrials.gov/ct2/results?term=NCT01644773&Search=Search
   Google Scholar