Pharmacokinetics of crizotinib in NSCLC patients

Expert Opinion on Drug Metabolism and Toxicology

Volumn 11, Issue 5, 2015, Pages 835-842

  Hamilton, Gerhard ^a   Rath, Barbara ^a   Burghuber, Otto ^b  

^a Ludwig Boltzmann Cluster   (Austria)

^b LUDWIG BOLTZMANN INSTITUTE FOR LUNG VASCULAR RESEARCH   (Austria)

Author keywords

Anaplastic lymphoma kinase; Crizotinib; NSCLC; Pharmacokinetics; Tyrosine kinase inhibitor

Indexed keywords

ALECTINIB; ANAPLASTIC LYMPHOMA KINASE; CRIZOTINIB; CYTOCHROME C OXIDASE; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DOXORUBICIN; ESOMEPRAZOLE; KETOCONAZOLE; LACTAM; LANSOPRAZOLE; LIVER ENZYME; MIDAZOLAM; OMEPRAZOLE; PACLITAXEL; PF 06260182; PLATINUM; PROTON PUMP INHIBITOR; RHODAMINE 123; RIFAMPICIN; TOPOTECAN; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE;

ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER PATIENT; CLINICAL STUDY; DIARRHEA; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG TRANSPORT; ENZYME BLOOD LEVEL; ETHNICITY; FOOD; HUMAN; HYPOGONADISM; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; MULTIPLE DRUG DOSE; NAUSEA; NON SMALL CELL LUNG CANCER; NONHUMAN; PNEUMONIA; SIDE EFFECT; STEADY STATE; STOMACH PH; TIME TO MAXIMUM PLASMA CONCENTRATION; TUMOR GROWTH; VISUAL DISORDER; VOMITING; ANIMAL; CARCINOMA, NON-SMALL-CELL LUNG; GENE REARRANGEMENT; GENETICS; LUNG NEOPLASMS; MUTATION;

ANIMALS; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; GENE REARRANGEMENT; HUMANS; LUNG NEOPLASMS; MAXIMUM TOLERATED DOSE; MUTATION; PROTEIN KINASE INHIBITORS; PYRAZOLES; PYRIDINES; RECEPTOR PROTEIN-TYROSINE KINASES;

EID: 84928896069     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2015.1021685     Document Type: Article

References (38)

1. 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.
2. Shackelford RE, Vora M, Mayhall K, et al. ALK-rearrangements and testing methods in non-small cell lung cancer: a review. Genes Cancer 2014;5:1-14.
3. Perner S, Wagner PL, Demichelis F, et al. EML4-ALK fusion lung cancer: a rare acquired event. Neoplasia 2008;10:298-302
4. Cui JJ, Tran-Dube M, Shen H, et al. Structure based drug design of crizotinib (PF-02341066), a potent and selective dual inhibitor of mesenchymal-epithelial transition factor (c-MET) kinase and anaplastic lymphoma kinase (ALK). J Med Chem 2011;54:6342-63.
5. Solomon B, Wilner KD, Shaw AT. Current status of targeted therapy for anaplastic lymphoma kinase-rearranged non-small cell lung cancer. Clin Pharmacol Ther 2014;95:15-23
6. Xu H, O'Gorman M, Boutros T, et al. Evaluation of crizotinib absolute bioavailability, the bioequivalence of three oral formulations, and the effect of food on crizotinib pharmacokinetics in healthy subjects. J Clin Pharmacol 2015;55(1):104-13
7. 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.
8. Zhang X, Zhang S, Yang X, et al. Fusion of EML4 and ALK is associated with development of lung adenocarcinomas lacking EGFR and KRAS mutations and is correlated with ALK expression. Mol Cancer 2010;9:188
9. Shaw AT, Engelman JA. ALK in lung cancer: past, present, and future. J Clin Oncol 2013;31:1105-11
10. Malik SM, Maher VE, Bijwaard KE, et al. U. S. Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic nonsmall cell lung cancer that is anaplastic lymphoma kinase positive. Clin Cancer Res 2014;20:2029-34
11. Weickhardt AJ, Aisner DL, Franklin WA, et al. Diagnostic assays for identification of anaplastic lymphoma kinase-positive non-small cell lung cancer. Cancer 2013;119:1467
12. 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
13. Toyokawa G, Seto T. ALK inhibitors: what is the best way to treat patients with ALK+ non-small-cell lung cancer Clin Lung Cancer 2014;15:313-19
14. Kazandjian D, Blumenthal GM, Chen HY, et al. FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements. Oncologist 2014;19:e5-e11
15. Qian H, Gao F, Wang H, et al. The efficacy and safety of crizotinib in the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer: a meta-analysis of clinical trials. BMC Cancer 2014;14:683
16. Costa DB, Kobayashi S, Pandya SS, et al. CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol 2011;29:e443-5
17. Maillet D, Martel-Lafay I, Arpin D, P-erol M. Ineffectiveness of crizotinib on brain metastases in two cases of lung adenocarcinoma with EML4-ALK rearrangement. J Thorac Oncol 2013;8:e30
18. Yamazaki S. Translational pharmacokinetic-pharmacodynamic modeling from nonclinical to clinical development: a case study of anticancer drug, crizotinib. AAPS J 2013;15:354-66
19. Yamazaki S, Vicini P, Shen Z, et al. Pharmacokinetic/pharmacodynamic modeling of crizotinib for anaplastic lymphoma kinase inhibition and antitumor efficacy in human tumor xenograft mouse models. J Pharmacol Exp Ther 2012;340:549-57
20. Li C, Alvey C, Bello A, et al. Pharmacokinetics (PK) of crizotinib (PF-02341066) in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. J Clin Oncol 2011;29(Suppl):abstr. e13065
21. Food and Drug Administration. Available from: www.accessdata.fda.gov/drugsatfdadocs/label/2011/202570s000lbl. pdf
22. EMEA report. Available from: www.ema.europa.eu/WC500134761. pdf.
23. Frampton JE. Crizotinib: a review of its use in the treatment of anaplastic lymphoma kinase-positive, advanced non-small cell lung cancer. Drugs 2013;73:2031-51
24. Johnson TR, Tan W, Goulet L, et al. Metabolism, excretion and pharmacokinetics of [14C]crizotinib following oral administration to healthy subjects. Xenobiotica 2014;18:1-15.
25. Timm A, Kolesar JM. Crizotinib for the treatment of non-small-cell lung cancer. Am J Health Syst Pharm 2013;70:943-7
26. Mosse 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
27. Zhou WJ, Zhang X, Cheng C, et al. Crizotinib (PF-02341066) reverses multidrug resistance in cancer cells by inhibiting the function of P-glycoprotein. Br J Pharmacol 2012;166:1669-83
28. Landi L. Cappuzzo. Management of NSCLC: focus on crizotinib. Expert Opin Pharmacother 2014;10:1-11
29. Stinchcombe TE. Novel agents in development for advanced non-small cell lung cancer. Ther Adv Med Oncol 2014;6(5):240-53
30. Heigener DF, Reck M. Crizotinib. Recent Results Cancer Res 2014;201:197-205
31. Esfahani K, Agulnik JS, Cohen V. A Systemic review of resistance mechanisms and ongoing clinical trials in alk-rearranged non-small cell lung cancer. Front Oncol 2014;4:174
32. 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.
33. Kim YH, Ozasa H, Nagai H, et al. High-dose crizotinib for brain metastases refractory to standard-dose crizotinib. J Thorac Oncol 2013;8:e85-6
34. Iacono D, Chiari R, Metro G, et al. Future options for ALK-positive nonsmall cell lung cancer. Lung Cancer 2015. [Epub ahead of print]
35. Chuan Tang S, Nguyen LN, Sparidans RW, et al. Increased oral availability and brain accumulation of the ALK inhibitor crizotinib by coadministration of the P-glycoprotein (ABCB1) and breast cancer resistance protein (ABCG2) inhibitor elacridar. Int J Cancer 2014;134:1484-94
36. Miyajima N, Tsutsumi S, Sourbier C, et al. The HSP90 inhibitor ganetespib synergizes with the MET kinase inhibitor crizotinib in both crizotinib-sensitive and-resistant MET-driven tumor models. Cancer Res 2013;73(23):7022-33
37. Yang L, Li G, Zhao L, et al. Blocking the PI3K pathway enhances the efficacy of ALK-targeted therapy in EML4-ALK-positive non-small cell lung cancer. Tumour Biol 2014;35(10):9759-67
38. Rolfo C, Sortino G, Smits E, et al. Immunotherapy: is a minor god yet in the pantheon of treatments for lung cancer Expert Rev Anticancer Ther 2014;14(10):1173-87