Pharmacokinetics of eribulin mesylate in patients with solid tumors and hepatic impairment

Cancer Chemotherapy and Pharmacology

Volumn 70, Issue 6, 2012, Pages 823-832

  Devriese, L A ^a   Witteveen, P O ^b   Marchetti, S ^a   Mergui Roelvink, M ^a   Reyderman, L ^c   Wanders, J ^d   Jenner, A ^d   Edwards, G ^d   Beijnen, J H ^e,f   Voest, E E ^b   Schellens, J H M ^a,e  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c EISAI INC   (United States)

^d EISAI CO LTD   (Japan)

^e UTRECHT UNIVERSITY   (Netherlands)

^f SLOTERVAART HOSPITAL   (Netherlands)

Author keywords

Child Pugh; Eribulin mesylate; Hepatic impairment; Microtubule dynamics Inhibitor; Pharmacokinetics

Indexed keywords

ERIBULIN;

ADULT; AGED; ALOPECIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; CLINICAL ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; LEUKOPENIA; LIVER FAILURE; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NETHERLANDS; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SOLID TUMOR; UNSPECIFIED SIDE EFFECT;

AGED; ANALYSIS OF VARIANCE; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DRUG ADMINISTRATION SCHEDULE; FEMALE; FURANS; HEPATIC INSUFFICIENCY; HUMANS; KETONES; MALE; MIDDLE AGED; NEOPLASMS; NETHERLANDS; TREATMENT OUTCOME;

EID: 84871254846     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-012-1976-x     Document Type: Article

References (30)

1. Verbeeck RK, Horsmans Y (1998) Effect of hepatic insufficiency on pharmacokinetics and drug dosing. Pharm World Sci 20:183-192
2. Donelli MG, Zucchetti M, Munzone E et al (1998) Pharmacokinetics of anticancer agents in patients with impaired liver function. Eur J Cancer 34:33-46
3. U.S. Food and Drug Administration. Guidance for industry. Pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling. http://www.fda.gov/downloads/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ucm072123.pdf. 2003. Last accessed on 08 August 2012
4. European Medicines Agency Committee for medicinal products for human use (CHMP). Guideline on the investigation of the pharmacokinetics of medicinal products in patients with impaired hepatic function. CPMP/EMP/2339/02 http://www.ema.europa. eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500003122.pdf. Last accessed on 08 August 2012
5. Panday VR, Huizing MT, Willemse PH et al (1997) Hepatic metabolism of paclitaxel and its impact in patients with altered hepatic function. Semin Oncol 24:S11
6. Towle MJ, Salvato KA, Budrow J et al (2001) In vitro and in vivo anticancer activities of synthetic macrocyclic ketone analogues of halichondrin B. Cancer Res 61:1013-1021
7. Jordan MA, Kamath K, Manna T et al (2005) The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther 4:1086-1095
8. Okouneva T, Azarenko O, Wilson L et al (2008) Inhibition of centromere dynamics by eribulin (E7389) during mitotic metaphase. Mol Cancer Ther 7:2003-2011
9. Smith JA, Wilson L, Azarenko O et al (2010) Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochemistry 49:1331-1337
10. Vahdat LT, Pruitt B, Fabian CJ et al (2009) Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 27:2954-2961
11. Cortes J, O'Shaughnessy J, Loesch D et al (2011) Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 377:914-923
12. Cortes J, Vahdat L, Blum JL et al (2010) Phase II study of the halichondrin B analog eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine. J Clin Oncol 28:3922-3928
13. Goel S, Mita AC, Mita M et al (2009) A phase I study of eribulin mesylate (E7389), a mechanistically novel inhibitor of microtubule dynamics, in patients with advanced solid malignancies. Clin Cancer Res 15:4207-4212
14. Tan AR, Rubin EH, Walton DC et al (2009) Phase I study of eribulin mesylate administered once every 21 days in patients with advanced solid tumors. Clin Cancer Res 15:4213-4219
15. Zhang ZY, King BM, Pelletier RD et al (2008) Delineation of the interactions between the chemotherapeutic agent eribulin mesylate (E7389) and human CYP3A4. Cancer Chemother Pharmacol 62:707-716
16. Dresser GK, Spence JD, Bailey DG (2000) Pharmacokineticpharmacodynamic consequences and clinical relevance of cytochrome P450 3A4 inhibition. Clin Pharmacokinet 38:41-57
17. Pugh RN, Murray-Lyon IM, Dawson JL et al (1973) Transection of the oesophagus for bleeding oesophageal varices. Br J Surg 60:646-649
18. Oken MM, Creech RH, Tormey DC et al (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655
19. Cockcroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41
20. Cancer Therapy Evaluation Program NCI Common Terminology Criteria AE Version 3.0 (NCI-CTCAE v3.0) (2006)
21. U.S. National Institute of Health. http://www.clinicaltrials.gov. Accessed on 26 April 2011
22. Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216
23. Dubbelman AC, Rosing H, Thijssen B et al (2011) Validation of high-performance liquid chromatography-tandem mass spectrometry assays for the quantification of eribulin (E7389) in various biological matrices. J Chromatogr B Analyt Technol Biomed Life Sci 879:1149-1155
24. Dubbelman AC, Rosing H, Jansen RS et al (2012) Mass balance study of [14C]eribulin in patients with advanced solid tumors. Drug Metab Dispos 40:313-321
25. Devriese LA, Mergui-Roelvink M, Wanders J et al. (2012) Eribulin mesylate pharmacokinetics in patients with solid tumors receiving repeated oral ketoconazole. Invest New Drugs (Epub May 5) doi:10.1007/s10637-012-9829-3
26. Devriese LA, Witteveen PO, Wanders J et al. (2012) Pharmacokinetics of eribulin mesylate in patients with solid tumors receiving repeated oral rifampicin. Br J Clin Pharmacol (Epub 16 Jul 2012) doi:10.1111/j.1365-2125.2012. 04381.x
27. Taur JS, Desjardins CS, Schuck EL et al (2010) Interactions between the chemotherapeutic agent eribulin mesylate (E7389) and P-glycoprotein in CF-1 abcb1a-deficient mice and Caco-2 cells. Xenobiotica 41:320-326
28. Thiebaut F, Tsuruo T, Hamada H et al (1987) Cellular localization of the multidrug-resistance gene product P-glycoprotein in normal human tissues. Proc Natl Acad Sci U S A 84:7735-7738
29. Synold TW, Takimoto CH, Doroshow JH et al (2007) Doseescalating and pharmacologic study of oxaliplatin in adult cancer patients with impaired hepatic function: a National Cancer Institute Organ DysfunctionWorking Group study. Clin Cancer Res 13:3660-3666
30. Figg WD, Dukes GE, Lesesne HR et al (1995) Comparison of quantitative methods to assess hepatic function: Pugh's classification, indocyanine green, antipyrine, and dextromethorphan. Pharmacotherapy 15:693-700