The emerging role of ALK inhibitors in the treatment of advanced non-small cell lung cancer

Expert Opinion on Therapeutic Targets

Volumn 16, Issue SUPPL.2, 2012, Pages

  Galetta, Domenico ^a   Rossi, Antonio ^b   Pisconti, Salvatore ^b   Colucci, Giuseppe ^a  

^a NATIONAL CANCER INSTITUTE GIOVANNI PAOLO II   (Italy)

^b S G MOSCATI HOSPITAL   (Italy)

Author keywords

ALK translocation; crizotinib; target therapies

Indexed keywords

ANTINEOPLASTIC AGENT; ASP 3026; CARBOPLATIN; CEP 28122; CEP 37440; CH 5424802; CISPLATIN; CRIZOTINIB; DOCETAXEL; GANETESPIB; LDK 378; NMSE 628; NUCLEOPHOSMIN; PEMETREXED; TAE 684; UNCLASSIFIED DRUG; XL 228;

ADVANCED CANCER; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER PROGNOSIS; CANCER RESISTANCE; DIAGNOSTIC TEST; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; FATIGUE; HUMAN; LARGE CELL LYMPHOMA; LUNG NON SMALL CELL CANCER; NAUSEA; NONHUMAN; PATHOGENESIS; PERSONALIZED MEDICINE; PREDICTIVE VALUE; PREVALENCE; VISUAL DISORDER;

ANIMALS; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; DRUG RESISTANCE, NEOPLASM; HUMANS; ONCOGENE PROTEINS, FUSION; PROTEIN KINASE INHIBITORS; RECEPTOR PROTEIN-TYROSINE KINASES;

EID: 84858952799     PISSN: 14728222     EISSN: 17447631     Source Type: Journal    
DOI: 10.1517/14728222.2011.642372     Document Type: Article

References (56)

1. Jemal A, Center MM, Desantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev 2010;19:1893-907
2. NSCLC Meta-Analyses Collaborative Group. Chemotherapy in addition to supportive care improves survival in advanced non-small-cell lung cancer: a systematic review and meta-analysis of individual patient data from 16 randomized controlled trials. J Clin Oncol 2008;26:4617-25 The most recent meta-analysis regarding the role of chemotherapy based on individual data.
3. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002;346:92-8 This is the first randomized trial, to our knowledge, with 1200 patients that showed an equivalence between the different chemotherapies.
4. Lynch TJ, Bell DW, Sordella R, et al. 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 This reference and [5] present the first clinical evidence, to our knowledge, of correlation between EGFR activating mutations and sensitivity to gefitinib.
5. Paez JG, Janne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497-500 This reference and [4] present the first clinical evidence, to our knowledge, of correlation between EGFR activating mutations and sensitivity to gefitinib.
6. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361:947-57 The first, to our knowledge, clinical Phase III trial showing a strong progression-free survival advantage for patients harboring EGFR activating mutation in comparison with chemotherapy.
7. Zhou C, Wu YL, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2011;12:735-42
8. Rikova K, Guo A, Zeng Q, et al. Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell 2007;131:1190-203 (Pubitemid 350235027)
9. 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 The first report, to our knowledge, on the identification of EML4-ALK translocation as a new target for NSCLC.
10. Palmer RH, Vernersson E, Grabbe C, Hallberg B. Anaplastic lymphoma kinase: signaling in development and disease. Biochem J 2009;420:345-61
11. Mosse YP, Wood A, Maris JM. Inhibition of ALK signaling for cancer therapy. Clin Cancer Res 2009;15:5609-14
12. 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;263:1281-4 (Pubitemid 24107549)
13. Wan W, Albom MS, Lu L, et al. Anaplastic lymphoma kinase activity is essential for the proliferation and survival of anaplastic large cell lymphoma cells. Blood 2006;107:1617-23 (Pubitemid 43242400)
14. Piva R, Chiarle R, Manazza AD, et al. Ablation of oncogenic ALK is a viable therapeutic approach for anaplastic large-cell lymphomas. Blood 2006;107:689-97 (Pubitemid 43076395)
15. 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;15:3143-9
16. Koivunen JP, Mermel C, Zejnullahu K, et al. EML4-ALK fusion gene and efficacy of an ALK kinase inhibitor in lung cancer. Clin Cancer Res 2008;14:4275-83
17. Perner S, Wagner PL, Demichelis F, et al. EML4-ALK fusion lung cancer: a rare acquired event. Neoplasia 2008;10:298-302 (Pubitemid 351328588)
18. 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
19. 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;68:4971-6 The first identification, to our knowledge, of novel isoforms of EML4-ALK transforming gene.
20. Soda M, Takada S, Takeuchi K, et al. A mouse model for EML4-ALK-positive lung cancer. Proc Natl Acad Sci USA 2008;105:19893-7
21. 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 The first clinical evidence, to our knowledge, of crizotinib activity in patients with EML4-ALK translocation.
22. Weinstein IB, Joe A. Oncogene addiction. Cancer Res 2008;68:3077-80
23. Camidge DR, Kono SA, Flacco A, et al. Optimizing the detection of lung cancer patients harboring anaplastic lymphoma kinase (ALK) gene rearrangements potentially suitable for ALK inhibitor treatment. Clin Cancer Res 2010;16:5581-90
24. Rodig SJ, Mino-Kenudson M, Dacic S, et al. Unique clinicopathologic features characterize ALK-rearranged lung adenocarcinoma in the western population. Clin Cancer Res 2009;15:5216-23
25. Yi ES, Boland JM, Maleszewski JJ, et al. Correlation of IHC and FISH for ALK gene rearrangement in non-small cell lung carcinoma. IHC score algorithm for FISH. J Thorac Oncol 2011;6:459-65 This paper is important for its description of the possibility of using IHC instead of FISH test searching for the ALK translocation.
26. Paik JH, Choe G, Kim H, et al. Screening of anaplastic lymphoma kinase rearrangement by immunohistochemistry in non-small cell lung cancer. correlationwith fluorescence in situ hybridization. J Thorac Oncol 2011;6:466-72
27. Camidge DR, Hirsch FR, Varella-Garcia M, Franklin WA. Finding ALK-positive lung cancer what are we really looking for? J Thorac Oncol 2011;6:411-13 A recent editorial written by the authors who have most studied the translocation of ALK.
28. 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
29. Camidge DR, Bang Y, Kwak EL, et al. Progression-free survival (PFS) from a phase I study of crizotinib (PF-02341066) in patients with ALK-positive non-small cell lung cancer (NSCLC). J Clin Oncol 2011;29(Suppl 1):abstract 2501
30. Hallberg B, Palmer RH. Crizotinib - Latest champion in the cancer wars? N Engl J Med 2010;363:1760-2 A recent editorial regarding the actual clinical role and perspectives of crizotinib.
31. Riely GJ, Kim DW, Crino L, et al. Phase II data for crizotinib (PF 02341066) in ALK-Positive Advanced Non-small cell lung cancer (NSCLC):PROFILE 1005 [abstract O31.05]. J Thorac Oncol 2011;6(Suppl 6):S411
32. 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;49:5759-68 (Pubitemid 44423712)
33. Yuan Y, Liao YM, Hsueh CT, Mirshahidi HR. Novel targeted therapeutics: inhibitors of MDM2, ALK and PARP. J Hematol Oncol 2011;4:16
34. Van Roosbroeck K, Cools J, Dierickx D, et al. ALK-positive large B-cell lymphomas with cryptic SEC31A-ALK and NPM1-ALK fusions. Haematologica 2010;95:509-13
35. Galkin AV, Melnick JS, Kim S, et al. Identification of NVP-TAE684, a potent, selective, and efficacious inhibitor of NPM-ALK. Proc Natl Acad Sci USA 2007;104:270-5 (Pubitemid 46068021)
36. Sakamoto H, Nobuhiro O, Tsukuda T, et al. CH5424802: a selective ALK inhibitor. Proceedings: AACR 102nd Annual Meeting 2011. Cancer Res 2011;71:8 Suppl 1 doi: 10.1158/1538-7445.AM2011-DDT01-02
37. Ardini E, Meninchincheri M, De Ponti C, et al. Characterization of NMS-E628, a small molecule inhibitor of anaplastic lymphoma kinase with antitumor efficacy in ALK-dependent lymphoma and non-small cell lung cancer models. Mol Cancer Ther 2009;8:Suppl 1 doi: 10.1158/1553-7163.TARG-09-A244
38. Li Y, Ye X, Liu J, et al. Evaluation of EML4-ALK fusion proteins in non-small cell lung cancer using small molecule inhibitors. Neoplasia 2011;13:1-11
39. Socinski MA, Koczywas M, Goldman J, et al. An open-label phase II study of the HSP90 inhibitor ganetespib (STA 9090) in patients with advanced non-small cell lung cancer (NSCLC) [abstract O43-01]. J Thorac Oncol 2011;6:S467
40. Normant E, Paez G, West KA, et al. The HSP90 inhibitor IPI-504 rapidly lowers EML4-ALK levels and induces tumor regression in ALK-driven NSCLC models. Oncogene 2011;30:2581-6
41. Kobayashi N, Toyooka S, Soh J, et al. The anti-proliferative effect of heat shock protein 90 inhibitor, 17-DMAG, on non-small-cell lung cancers being resistant to EGFR tyrosine kinase inhibitor. Lung Cancer 2011 [Epub ahead of print]
42. Wong K, Koczywas M, Goldman JW, et al. An open-label phase II study of the Hsp90 inhibitor ganetespib (STA-9090) as monotherapy in patients with advanced non-small cell lung cancer (NSCLC). J Clin Oncol 2011;29(Suppl): abstract 7500
43. Hanna N, Shepherd FA, Fossella FV, et al. Randomized Phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004;22:1589-97 (Pubitemid 41079796)
44. Scagliotti G, Hanna N, Fossella F, et al. The differential efficacy of pemetrexed according to NSCLC histology: a review of two Phase III studies. Oncologist 2009;14:253-63
45. Patel JD, Bonomi P, Socinski MA, et al. Treatment rationale and study design for the point break study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/ bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. Clin Lung Cancer 2009;10:252-6
46. Camidge DR, Kono SA, Lu S, et al. Anaplastic lymphoma kinase gene rearrangements in non-small cell lung cancer are associated with prolonged progression-free survival on Pemetrexed. J Thorac Oncol 2011;6:774-80
47. Jeong OK, Lee JO, Kim TM, et al. Anaplastic lymphoma kinase translocation: a predictive biomarker of pemetrexed in patients with non-small cell lung cancer. J Thorac Oncol 2011;6:1474-80
48. 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 Oncol 2011;12:1004-12
49. Kim HR, Shim HS, Chung JH, et al. Distinct clinical features and outcomes in never-smokers with non small cell lung cancer harbor EGFR or KRAS mutation or ALK rearrangement. Cancer 2011 [Epub ahead of print] This research revealed an important correlation regarding never smokers and mutation of EGFR, KRAS or ALK.
50. Butrynski JE, D'Adamo DR, Hornick JL, et al. Crizotinib in ALK-rearranged inflammatory myofibroblastic tumor. N Engl J Med 2010;363:1727-33
51. 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 The first evidence, to our knowledge, of resistance mechanisms to ALK inhibitors in EML4-ALK mutation lung cancer.
52. 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
53. Tiseo M, Gelsomino F, Boggiani D, et al. EGFR and EML4-ALK gene mutations in NSCLC: a case report of erlotinib-resistant patient with bothconcomitant mutations. Lung Cancer 2011;71:241-3
54. Gomez-Roca C, Raynaud CM, Penault-Llorca F, et al. Differential expression of biomarkers in primary non-small cell lung cancer and metastatic sites. J Thorac Oncol 2009;4:1212-20
55. Rossi A, Galetta D, Bottiglieri L, et al. Evaluation of ALK gene status in primary lung adenocarcinoma and lung metastases. J Thorac Oncol 2011;6:1146
56. Li R, Morris SW. Development of anaplastic lymphoma kinase (ALK) small-molecule inhibitors for cancer therapy. Med Res Rev 2008;28:372-412 (Pubitemid 351590540)