The efficacy of crizotinib in patients with ALK-positive nonsmall cell lung cancer

Therapeutic Advances in Respiratory Disease

Volumn 9, Issue 3, 2015, Pages 97-104

  Pender, Alexandra ^a   Popat, Sanjay ^a  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANAPLASTIC LYMPHOMA KINASE; CRIZOTINIB; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE;

BRADYCARDIA; BRAIN NEOPLASMS; CARCINOMA, NON-SMALL-CELL LUNG; CHEMICALLY INDUCED; CLINICAL TRIAL (TOPIC); DRUG RESISTANCE; DRUG-INDUCED LIVER INJURY; GENE REARRANGEMENT; GENETICS; HUMAN; HYPOGONADISM; LUNG NEOPLASMS; SECONDARY; ADVANCED CANCER; ANAPLASTIC LYMPHOMA KINASE GENE; CANCER RESISTANCE; CANCER SURVIVAL; CARCINOGENESIS; CLINICAL EFFECTIVENESS; DISEASE ACTIVITY; DRUG EFFICACY; DRUG MECHANISM; DRUG RESPONSE; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; GENE FUNCTION; GENE IDENTIFICATION; HEPATITIS; LIVER DYSFUNCTION; MOLECULAR DYNAMICS; MOLECULAR PATHOLOGY; NON SMALL CELL LUNG CANCER; ONCOGENE; OVERALL SURVIVAL; PRIORITY JOURNAL; REVIEW; SURVIVAL RATE;

BRADYCARDIA; BRAIN NEOPLASMS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIALS AS TOPIC; DRUG RESISTANCE, NEOPLASM; DRUG-INDUCED LIVER INJURY; GENE REARRANGEMENT; HUMANS; HYPOGONADISM; LUNG NEOPLASMS; PROTEIN KINASE INHIBITORS; PYRAZOLES; PYRIDINES; RECEPTOR PROTEIN-TYROSINE KINASES;

EID: 84930717379     PISSN: 17534658     EISSN: 17534666     Source Type: Journal    
DOI: 10.1177/1753465815577738     Document Type: Review

References (46)

1. Blackhall F.H. Evans T. L. Han J. Salgia R. Moro-Sibilot D. Gettinger S. (2012) Impact of crizotinib treatment on patient-reported symptoms and quality of life (QOL) in advanced ALK-positive non-small cell lung cancer (NSCLC). Ann Oncol 23(Suppl. 9): 400–446.
2. Choi Y.L. Soda M. Yamashita Y. Ueno T. Takashima J. Nakajima T. (2010) EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors. N Engl J Med 363(18): 1734–1739. doi:10.1056/NEJMoa1007478.
3. Choi Y.L. Takeuchi K. Soda M. Inamura K. Togashi Y. Hatano S. (2008) Identification of novel isoforms of the EML4-ALK transforming gene in non-small cell lung cancer. Cancer Res 68(13): 4971–4976. doi:10.1158/0008-5472.CAN-07-6158.
4. Christensen J.G. Zou H.Y. Arango M.E. Li Q. Lee J.H. McDonnell S.R. (2007) 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 Therapeut 6(12 Pt 1): 3314–3322. doi:10.1158/1535-7163.MCT-07-0365.
5. Commitee for Medicinal Products for Human Use (n.d.) Xalkori European Public Assessment Report. European Medicines Agency. Available at: http://www.ema.europa.euemainindex.jspcurlpagesmedicineshumanmedicineshumanmed.jspmidWcbacd
6. Committee for Medicinal Products for Human Use (2014, April 14) Xalkori, Summary of Product Characteristics. European Medicines Agency. Available at: http://www.ema.europa.euemainindex.jspcurlpagesmedicineshumanmedicineshumanmed.jspmidWcbacd
7. Costa D.B. Kobayashi S. Pandya S.S. Yeo W.-L. Shen Z. Tan W. (2011) CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol 29(15): e443–e445. doi:10.1200/JCO.2010.34.1313.
8. Costa D.B. Shaw A.T. Ou S.-H.I. Solomon B.J. Riely G.J. Ahn M.-J. (2015) Clinical experience with crizotinib in patients with advanced ALK-rearranged non-small-cell lung cancer and brain metastases. J Clin Oncol. Epub ahead of print 26 January 2015. doi:10.1200/JCO.2014.59.0539.
9. Crino L. Kim D. Riely G.J. Janne P.A. Blackhall F.H. Camidge D.R. (2011) Initial phase II results with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): PROFILE 1005. J Clin Oncol 29(15s).
10. Doebele R.C. Pilling A.B. Aisner D.L. Kutateladze T.G. Le A.T. Weickhardt A.J. (2012) Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer. Clin Cancer Res 18(5): 1472–1482. doi:10.1158/1078-0432.CCR-11-2906.
11. Fleishman S.B. Khan H. Homel P. Suhail M.F. Strebel-Amrhein R. Mohammad F. (2010) Testosterone levels and quality of life in diverse male patients with cancers unrelated to androgens. J Clin Oncol 28(34): 5054–5060. doi:10.1200/JCO.2010.30.3818.
12. Gadgeel S.M. Gandhi L. Riely G.J. Chiappori A.A. West H.L. Azada M.C. (2014) 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 15(10): 1119–1128. doi:10.1016/S1470-2045(14)70362-6.
13. Gainor J.F. Varghese A.M. Ou S.H.I. Kabraji S. Awad M.M. Katayama R. (2013) ALK rearrangements are mutually exclusive with mutations in EGFR or KRAS: an analysis of 1,683 patients with non-small cell lung cancer. Clin Cancer Res 19(15): 4273–4281. doi:10.1158/1078-0432.CCR-13-0318.
14. Jefferson E. (2011) FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer. FDA NEWS RELEASE. Available at: http://www.Fda.Gov/NewsEvents/Newsroom/PressAnnouncements.Ucm.Htm
15. Kazandjian D. Blumenthal G.M. Chen H.-Y. He K. Patel M. Justice R. (2014) FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements. Oncologist 19(10): e5–e11. doi:10.1634/theoncologist.2014-0241.
16. Kim D. Ahn M. Yang P. Liu X. De Pas T. Crinò L. (2012) Updated results of a global phase II study with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol (30s) [abstr 8033].
17. Kim D. Crino L. Janne P.A. Blackhall F. Camidge D.R. Hirsch V. (2011) Phase 2 data for crizotinib (PF-02341066) in ALK-positive advanced non-small cell lung cancer (NSCLC): PROFILE 2005. J Thorac Oncol 6(6s).
18. Kim Y.H. Ozasa H. Nagai H. Sakamori Y. Yoshida H. Yagi Y. (2013) High-dose crizotinib for brain metastases refractory to standard-dose crizotinib. J Thorac Oncol 8(9): e85–e86.
19. Kobayashi S. Boggon T.J. Dayaram T. Jånne P.A. Kocher O. Meyerson M. (2005) EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. N Engl J Med 352(8): 786–792. doi:10.1056/NEJMoa044238.
20. Kris M.G. Johnson B.E. Berry L.D. Kwiatkowski D.J. Iafrate A.J. Wistuba I.I. (2014) Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. J Am Med Assoc 311(19): 1998–2006. doi:10.1001/jama.2014.3741.
21. Kwak E.L. Bang Y.-J. Camidge D. R. Shaw A. T. Solomon B. Maki R.G. (2010) Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 363(18): 1693–1703. doi:10.1056/NEJMoa1006448.
22. McDermott U. Iafrate A.J. Gray N.S. Shioda T. Classon M. Maheswaran S. (2008) Genomic alterations of anaplastic lymphoma kinase may sensitize tumors to anaplastic lymphoma kinase inhibitors. Cancer Res 68(9): 3389–3395. doi:10.1158/0008-5472.CAN-07-6186.
23. Mok T. Kim D.W. Solomon B.J. Nakagawa K. Mekhail T.M. Felip E. (2014) First-line crizotinib versus pemetrexed-cisplatin or pemetrexed-carboplatin in patients (pts) with advanced ALK-positive non-squamous non-small cell lung cancer (NSCLC): results of a phase III study (PROFILE 1014). J Clin Oncol 32(5s) [abstr 8002].
24. Mok T.S. Wu Y.-L. Thongprasert S. Yang C.-H. Chu D.-T. Saijo N. (2009) Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361(10): 947–957. doi:10.1056/NEJMoa0810699.
25. Otterson G.A. Riely G.J. Shaw A.T. Crino L. Kim D.W. Martins R. (n.d.) Clinical characteristics of ALK+ NSCLC patients (pt) treated with crizotinib beyond disease progression (PD): potential implications for management. J Clin Oncol 30(15s).
26. Ou S.H.I. Tang Y. Polli A. Wilner K. D. Schnell P. (n.d.) Characterization of heart rate (HR) changes during crizotinib treatment: A retrospective analysis of 1,053 ALK+ NSCLC patients. J Clin Oncol 32(5s) [abstr 8106].
27. Ou S.-H.I. Tong W.P. Azada M. Siwak-Tapp C. Dy J. Stiber J.A. (2013) Heart rate decrease during crizotinib treatment and potential correlation to clinical response. Cancer 119(11): 1969–1975. doi:10.1002/cncr.28040.
28. Popat S. Mok T. Yang J.C.-H. Wu Y.-L. Lungershausen J. Stammberger U. (2014) Afatinib in the treatment of EGFR mutation-positive NSCLC–a network meta-analysis. Lung Cancer 85(2): 230–238. doi:10.1016/j.lungcan.2014.05.007.
29. Rikova K. Guo A. Zeng Q. Possemato A. Yu J. Haack H. (2007) Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell 131(6): 1190–1203. doi:10.1016/j.cell.2007.11.025.
30. Ross Camidge D.D. Bang Y.-J. Kwak E.L. Iafrate A.J. Varella-Garcia M. Fox S.B. (2012) Activity and safety of crizotinib in patients with. Lancet Oncol 13(10): 1011–1019. doi:10.1016/S1470-2045(12)70344-3.
31. Sasaki T. Koivunen J. Ogino A. Yanagita M. Nikiforow S. Zheng W. (2011) A novel ALK secondary mutation and EGFR signaling cause resistance to ALK kinase inhibitors. Cancer Res 71(18): 6051–6060. doi:10.1158/0008-5472.CAN-11-1340.
32. Sequist L.V. Waltman B.A. Dias-Santagata D. Digumarthy S. Turke A.B. Fidias P. (2011) Genotypic and histological evolution of lung cancers acquiring resistance to EGFR inhibitors. Sci Trans Med 3(75): 75ra26.
33. Shaw A.T. Kim D.-W. Mehra R. Tan D.S.W. Felip E. Chow L.Q.M. (2014) Ceritinib in ALK-rearranged non'small-cell lung cancer. N Engl J Med 370(13): 1189–1197. doi:10.1056/nejmoa1311107.
34. Shaw A.T. Kim D.-W. Nakagawa K. Seto T. Crino L. Ahn M.-J. (2013) Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 368(25): 2385–2394. doi:10.1056/NEJMoa1214886.
35. Shaw A.T. Yeap B.Y. Solomon B.J. Riely G.J. Gainor J. (2011) Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis. Lancet Oncol 12(11): 1004–1012. doi:10.1016/S1470-2045(11)70232-7.
36. Shepherd F.A. Dancey J. Ramlau R. Mattson K. Gralla R. O–Rourke M. (2000) Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18(10): 2095–2103.
37. Soda M. Choi Y.L. Enomoto M. Takada S. Yamashita Y. Ishikawa S. (2007) Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 448(7153): 561–566. doi:10.1038/nature05945.
38. Soda M. Isobe K. Inoue A. Maemondo M. Oizumi S. Fujita Y. (2012) A prospective PCR-based screening for the EML4-ALK oncogene in non-small cell lung cancer. Clin Cancer Res 18(20): 5682–5689. doi:10.1158/1078-0432.CCR-11-2947.
39. Solomon B. Felip E. Blackhall F.H. Mok T. Kim D. Wu J. (2014) Overall and intracranial (IC) efficacy results and time to symptom deterioration in PROFILE 1014: 1st-line crizotinib vs pemetrexed ∑ platinum chemotherapy (PPC) in patients (pts) with advanced ALK-positive non-squamous non-small cell lung cancer (NSCLC). Ann Oncol 25(Suppl. 4): iv264–iv270.
40. Takeda M. Okamoto I. Nakagawa K. (2013) Clinical impact of continued crizotinib administration after isolated central nervous system progression in patients with lung cancer positive for ALK rearrangement. J Thorac Oncol 8(5): 654–657.
41. Takeuchi K. Choi Y.L. Soda M. Inamura K. Togashi Y. Hatano S. (2008) Multiplex reverse transcription-PCR screening for EML4-ALK fusion transcripts. Clin Cancer Res 14(20): 6618–6624. doi:10.1158/1078-0432.CCR-08-1018.
42. Takeuchi K. Choi Y.L. Togashi Y. Soda M. Hatano S. Inamura K. (2009) KIF5B-ALK, a novel fusion oncokinase identified by an immunohistochemistry-based diagnostic system for ALK-positive lung cancer. Clin Cancer Res 15(9): 3143–3149. doi:10.1158/1078-0432.CCR-08-3248.
43. Travis W.D. Brambilla E. Noguchi M. Nicholson A.G. Geisinger K. Yatabe Y. (2013) Diagnosis of lung cancer in small biopsies and cytology: implications of the 2011 International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society Classification. Arch Pathol Lab Med 137(5): 668–684. doi:10.5858/arpa.2012-0263-RA.
44. Weickhardt A.J. Rothman M.S. Salian-Mehta S. Kiseljak-Vassiliades K. Oton A.B. Doebele R.C. (2012a) Rapid-onset hypogonadism secondary to crizotinib use in men with metastatic nonsmall cell lung cancer. Cancer 118(21): 5302–5309. doi:10.1002/cncr.27450.
45. Weickhardt A.J. Scheier B. Burke J.M. Gan G. Lu X. Bunn P.A.J. (2012b) Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancer. J Thorac Oncol 7(12): 1807–1814.
46. Yamaguchi N. Lucena-Araujo A.R. Nakayama S. de Figueiredo-Pontes L.L. Gonzalez D.A. Yasuda H. (2014) Dual ALK and EGFR inhibition targets a mechanism of acquired resistance to the tyrosine kinase inhibitor crizotinib in ALK rearranged lung cancer. Lung Cancer 83(1): 37–43. doi:10.1016/j.lungcan.2013.09.019.