Re-evaluating progression in an era of progress: A review of first- and second-line treatment options in anaplastic lymphoma kinase-positive non-small cell lung cancer

Oncologist

Volumn 21, Issue 6, 2016, Pages 755-761

  Castellanos, Emily H ^a   Horn, Leora ^a  

^a VANDERBILT INGRAM CANCER CENTER   (United States)

Author keywords

Anaplastic lymphoma kinase; Non small cell lung cancer; Oligoprogression; Targeted therapy

Indexed keywords

6 AMINO 5 [1 (2,6 DICHLORO 3 FLUOROPHENYL)ETHOXY] N [4 (4 METHYL 1 PIPERAZINYLCARBONYL)PHENYL] 3 PYRIDAZINECARBOXAMIDE; ALECTINIB; ANAPLASTIC LYMPHOMA KINASE; ANAPLASTIC LYMPHOMA KINASE INHIBITOR; BRIGATINIB; CERITINIB; CRIZOTINIB; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; LORLATINIB; LUMINESPIB; PROTEIN KINASE B; SCATTER FACTOR RECEPTOR; CARBAZOLE DERIVATIVE; PIPERIDINE DERIVATIVE; PROTEIN TYROSINE KINASE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE; CARBOPLATIN; CISPLATIN; DOCETAXEL; ERLOTINIB; GEFITINIB; PEMETREXED;

ARTICLE; BLOOD BRAIN BARRIER; BRAIN METASTASIS; DIARRHEA; DISEASE COURSE; EDEMA; EYE MOVEMENT DISORDER; FATIGUE; HUMAN; HYPERCHOLESTEROLEMIA; LUNG ADENOCARCINOMA; MOLECULARLY TARGETED THERAPY; MUTATION; NAUSEA; NEUROPATHY; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT RESPONSE; VOMITING; ANTAGONISTS AND INHIBITORS; CARCINOMA, NON-SMALL-CELL LUNG; ENZYMOLOGY; LUNG NEOPLASMS; MORTALITY; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER MORTALITY; CANCER RADIOTHERAPY; CANCER SURGERY; DRUG EFFICACY; MAXIMUM TOLERATED DOSE; NONHUMAN; REVIEW; TREATMENT DURATION;

CARBAZOLES; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE PROGRESSION; HUMANS; LUNG NEOPLASMS; PIPERIDINES; PYRAZOLES; PYRIDINES; RECEPTOR PROTEIN-TYROSINE KINASES;

EID: 84975322317     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2015-0396     Document Type: Article

References (53)

1. Cataldo VD, Gibbons DL, Pérez-Soler R et al. Treatmentofnon-small-cell lung cancerwith erlotinib or gefitinib. N Engl JMed 2011;364:947-955.
2. Soda M, Choi YL, Enomoto M et al. Identification of the transforming EML4-ALK fusion gene in nonsmall- cell lung cancer. Nature 2007;448:561-566.
3. ALK in non-small cell lung cancer (NSCLC). Available at http://www.mycancergenome.org/content/disease/lung-cancer/alk/. Accessed August 9, 2015.
4. Shaw AT, Yeap BY, Mino-Kenudson M et al. Clinical features and outcome of patients with nonsmall- cell lung cancer who harbor EML4-ALK. J Clin Oncol 2009;27:4247-4253.
5. Inamura K, Takeuchi K, Togashi Y et al. EML4-ALK lung cancers are characterized by rare other mutations, a TTF-1 cell lineage, an acinar histology, and young onset. Mod Pathol 2009;22:508-515.
6. Kwak EL, Camidge DR, Clark JI et al. Clinical activity observed in a phase I dose escalation trial of an oral c-met and ALK inhibitor, PF-02341066. Paper presented at: American Society of Clinical Oncology Annual Meeting; May 29-June 2, 2009; Orlando, FL.
7. Camidge DR, Bang YJ, Kwak EL et al. Activity and safety ofcrizotinib in patients with ALK-positivenonsmall- cell lung cancer: Updated results from a phase 1 study. Lancet Oncol 2012;13:1011-1019.
8. Crino L, Kim DW, Riely GJ et al. InitialphaseII results with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): Profile 1005. Paper presented at: American Society of Clinical Oncology Annual Meeting; June 3-7, 2011; Chicago, IL.
9. Shaw AT, Kim DW, Nakagawa K et al. Crizotinib versuschemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013;368:2385-2394.
10. Solomon BJ, Mok T, Kim DW et al; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. NEngl JMed 2014;371:2167-2177.
11. Choi YL, Soda M, Yamashita Y et al; ALK Lung Cancer Study Group. EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors. N Engl J Med 2010;363:1734-1739.
12. Katayama R, Shaw AT, Khan TM et al. Mechanisms of acquired crizotinib resistance inALK-rearranged lung Cancers. Sci TranslMed 2012;4:120ra17.
13. Doebele RC, Pilling AB, Aisner DL et al. Mechanisms of resistance to crizotinib in patients withALK generearranged non-small cell lung cancer. Clin Cancer Res 2012;18:1472-1482.
14. 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;71:6051-6060.
15. Costa DB, Kobayashi S, Pandya SS et al. CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol 2011;29:e443-e445.
16. Weickhardt AJ, Scheier B, Burke JM et al. Continuation of EGFR/ALK inhibition after local Therapy of oligo progressives disease in EGFRmutant (Mt) and ALK1non-small cell lung cancer (NSCLC). Paper presented at: American Society of Clinical Oncology AnnualMeeting; June 1-5, 2012; Chicago, IL.
17. Costa DB, Shaw AT, Ou SH et al. Clinical experience with crizotinib in patients with advanced ALK-rearranged non-small-cell lung cancer and brain metastases. J Clin Oncol 2015;33:1881-1888.
18. Friboulet L, Li N, Katayama R et al. TheALKinhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. Cancer Discov 2014;4:662-673.
19. Lovly CM, McDonald NT, Chen H et al. Rationale for co-targeting IGF-1R and ALK in ALK fusion-positive lung cancer. Nat Med 2014;20:1027-1034.
20. Shaw AT, Kim DW, Mehra R et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl JMed 2014;370:1189-1197.
21. Felip E, Kim DW, Mehra R et al. Efficacyandsafety of ceritinib in patients (pts) with advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC): An update of ASCEND-1. Paper presented at: European Society for Medical Oncology 2014; September 27, 2014; Madrid, Spain.
22. Mok T, Spigel DR, Felip E et al.ASCEND-2:Asinglearm, open-label,multicenter phase II study of ceritinib in adult patients with ALK-rearranged non-small cell lungcancer previously treated withh chemotherapyand crizotinib. J Clin Oncol 2015;33:8059a.
23. Felip E, Orlov S, Park K et al. ASCEND-3: A singlearm, open-label, multicenter phase II studyof ceritinib in ALKi-naïve adult patients (pts) with ALK-rearranged (ALK1) non-small cell lung cancer (NSCLC). Paper presented at: American Society of Clinical Oncology Annual Meeting; May 29-June 2, 2015; Chicago, IL.
24. Kodama T, Tsukaguchi T, Yoshida M et al. Selective ALK inhibitor alectinib with potent antitumor activity in models of crizotinib resistance. Cancer Lett 2014;351:215-221.
25. Sakamoto H, Tsukaguchi T, Hiroshima S et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell 2011;19:679-690.
26. 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;14:590-598.
27. Gadgeel SM, Gandhi L, Riely GJ et al. Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALKrearranged non-small-cell lung cancer (AF-002JG): Results from the dose-finding portion of a phase 1/2 study. Lancet Oncol 2014;15:1119-1128.
28. Shaw AT, Gandhi L, Gadgeel S et al. Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: A single-group, multicentre, phase 2 trial. Lancet Oncol 2016;17:234-242.
29. Rivera VM, A Njurn R, Wang F, et al. Efficacy and pharmacodynamic analysis ofAP26113, a potentand selective orally active inhibitor of anaplastic lymphoma kinase (ALK). Proceedings of the 101stAnnual Meeting of the American Association for Cancer Research; 2010 April 17-21, 2010; Washington, D.C.
30. Gettinger SN, Bazhenova L, Salgia R et al. Brigatinib (AP26113) Efficacy and Safety in ALK1 NSCLC: Phase 1/2 Trial Results.World Conference on Lung Cancer; 2015; Denver, CO.
31. 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. Paper presented at: The European Cancer Congress 2013; September 27-October 1, 2013; Amsterdam, Netherlands.
32. 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;71:4920-4931.
33. Horn L, Blumenschein G, Wakelee HA et al. A phase I/II trial of X-396, a novel ALK inhibitor, in patients with advanced solid tumors. Chicago Multidisciplinary Symposium in Thoracic Oncology; 2014.
34. Johnson TW, Richardson PF, Bailey S et al. Discovery of (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo- 10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo [4,3-h][2,5,11]-benzoxadiaza cyclotetradecine radecine-3- carbonitrile (PF-06463922), a macrocyclic inhibitor of anaplastic lymphomakinase(ALK) andc-ros oncogene 1 (ROS1) with preclinical brain exposure and broadspectrum potency against ALK-resistant mutations. JMed Chem 2014;57:4720-4744.
35. Bauer T, Solomon B, Besse B et al. Clinical Activity and Safety of the ALK/ROS1 TK Inhibitor PF-06463922 in Advanced NSCLC. World Conference on Lung Cancer; 2015; Denver, CO: J Thoracic Oncol.
36. Garon EB, Finn RS, Hamidi H et al. The HSP90 inhibitor NVP-AUY922 potently inhibits non-small cell lung cancer growth. Mol Cancer Ther 2013;12: 890-900.
37. Ueno T, Tsukuda K, Toyooka S et al. Strong antitumor effect of NVP-AUY922, a novel Hsp90 inhibitor, on non-small cell lung cancer. American Society of Clinical Oncology AnnualMeeting; 2012; Chicago, IL.
38. Garon EB, Moran T, Barlesi F et al. PhaseII studyof theHSP90 in hibit or AUY922 in patients with previously treated, advanced non-small cell lung cancer (NSCLC). Paper presented at: American Society of Clinical OncologyAnnualMeeting; June 1-5, 2012; Chicago, IL.
39. Gainor JF, Marcoux JP, Rabin M et al. A phase II trial of AUY922, a heat shock protein 90 (HSP90) inhibitor, in ALK-positive lung cancer patients previously treated with ALK inhibitors. Paper presented at: Sixteenth World Conference on Lung Cancer; September 6-9, 2015; Dover, CO.
40. Miller AB, Hoogstraten B, Staquet M et al. Reporting results of cancer treatment. Cancer 1981; 47:207-214.
41. Green S, Weiss GR. Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria. Invest New Drugs 1992;10:239-253.
42. Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-247.
43. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment ofCancer,NationalCancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-216.
44. Takeda M, Okamoto I, Nakagawa K. Clinical impact of continued crizotinib administration after isolated central nervous system progression in patients with lung cancer positive forALK rearrangement. J Thorac Oncol 2013;8:654-657.
45. Gan GN, Weickhardt AJ, Scheier B et al. Stereotactic radiation therapy can safely and durably control sites of extra-central nervous system oligoprogressive disease in anaplastic lymphoma kinasepositive lung cancer patients receiving crizotinib. Int J Radiat Oncol Biol Phys 2014;88:892-898.
46. Oxnard GR, Morris MJ, Hodi FS et al. When progressive disease does not mean treatment failure: Reconsidering the criteria for progression. J Natl Cancer Inst 2012;104:1534-1541.
47. Gandara DR, Li T, Lara PN et al. Acquired resistance to targeted therapies against oncogenedriven non-small-cell lung cancer: Approach to subtyping progressive disease and clinical implications. Clin Lung Cancer 2014;15:1-6.
48. Weickhardt AJ, Scheier B, Burke JM et al. Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancer. J Thorac Oncol 2012;7:1807-1814.
49. Chaft JE, Oxnard GR, Sima CS et al. Disease flare after tyrosine kinase inhibitor discontinuation in patients with EGFR-mutant lung cancer and acquired resistance to erlotinib or gefitinib: Implications for clinical trial design. Clin Cancer Res 2011;17:6298-6303.
50. Goldberg SB, Oxnard GR, Digumarthy S et al. Chemotherapy with Erlotinib orchemotherapy alone in advanced non-small cell lung cancerwith acquired resistance to EGFR tyrosine kinase inhibitors. The Oncologist 2013;18:1214-1220.
51. Soria JC, Wu YL, Nakagawa K et al. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): A phase 3 randomised trial. Lancet Oncol 2015;16:990-998.
52. Pop O, Pirvu A, Toffart AC et al. Disease flare after treatment discontinuation in a patient with EML4-ALK lung cancer and acquired resistance to crizotinib. J Thorac Oncol 2012;7:e1-e2.
53. Kuriyama Y, Kim YH, Nagai H et al. Disease flare after discontinuation of crizotinib in anaplastic lymphoma kinase-positive lung cancer. Case Rep Oncol 2013;6:430-433.