Comparison of temsirolimus pharmacokinetics in patients with renal cell carcinoma not receiving dialysis and those receiving hemodialysis: A case series

Clinical Therapeutics

Volumn 31, Issue 8, 2009, Pages 1812-1819

  Lunardi, Gianluigi ^a   Armirotti, Andrea ^b   Nicodemo, Maurizio ^c   Cavallini, Lucia ^d   Damonte, Gianluca ^b   Vannozzi, Maria O ^a   Venturini, Marco ^c  

^a UNIVERSITY OF GENOA   (Italy)

^b UNIVERSITY OF GENOA   (Italy)

^c SACRO CUORE DON CALABRIA HOSPITAL   (Italy)

^d Socio Sanitary Local Unity 22 Bussolengo   (Italy)

Author keywords

dialysis; hemodialysis; pharmacokinetics; renal cell carcinoma; sirolimus; temsirolimus

Indexed keywords

RAPAMYCIN; TEMSIROLIMUS;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; FEMALE; HALF LIFE TIME; HEMODIALYSIS; HEMODIALYSIS PATIENT; HISTOLOGY; HUMAN; KIDNEY CARCINOMA; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; METASTASIS; PATIENT PARTICIPATION; SINGLE DRUG DOSE; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CARCINOMA, RENAL CELL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; FEMALE; HALF-LIFE; HUMANS; KIDNEY NEOPLASMS; MALE; MASS SPECTROMETRY; MIDDLE AGED; RENAL DIALYSIS; SIROLIMUS; TISSUE DISTRIBUTION;

EID: 72149105604     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.08.018     Document Type: Article

References (21)

1. Gupta K., Miller J.D., Li J.Z., Russell M.W., and Charbonneau C. Epidemiologic and socioeconomic burden of metastatic renal cell carcinoma (mRCC): A literature review. Cancer Treat Rev. 34 (2008) 193-205
2. Kroog G.S., and Motzer R.J. Systemic therapy for metastatic renal cell carcinoma. Urol Clin North Am. 35 (2008) 687-701
3. Coppin C., Porzsolt F., Awa A., et al. Immunotherapy for advanced renal cell cancer. Cochrane Database Syst Rev. 1 (2005) CD001425
4. Coppin C., Le L., Porzsolt F., and Wilt T. Targeted therapy for advanced renal cell carcinoma. Cochrane Database Syst Rev. 2 (2008) CD006017
5. Meric-Bernstam F., and Mills G.B. Mammalian target of rapamycin. Semin Oncol. 31 Suppl 16 (2004) 10-17 discussion
6. Meric-Bernstam F., and Mills G.B. Mammalian target of rapamycin. Semin Oncol. 31 Suppl 16 (2004) 33
7. Thomas G.V., Tran C., Mellinghoff I.K., et al. Hypoxia-inducible factor determines sensitivity to inhibitors of mTOR in kidney cancer. Nat Med. 12 (2006) 122-127
8. Hudes G., Carducci M., Tomczak P., et al., Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 356 (2007) 2271-2281
9. Raymond E., Alexandre J., Faivre S., et al. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol. 22 (2004) 2336-2347
10. Torisel [package insert] (2007), Wyeth Pharmaceuticals Inc, Philadelphia, Pa
11. Maisonneuve P., Agodoa L., Gellert R., et al. Cancer in patients on dialysis for end-stage renal disease: An international collaborative study. Lancet. 354 (1999) 93-99
12. Kojima Y., Takahara S., Miyake O., et al. Renal cell carcinoma in dialysis patients: A single center experience. Int J Urol. 13 (2006) 1045-1048
13. Flanigan R.C., Mickisch G., Sylvester R., et al. Cytoreductive nephrectomy in patients with metastatic renal cancer: A combined analysis. J Urol. 171 (2004) 1071-1076
14. Lunardi G., Vannozzi M.O., Armirotti A., et al. Temsirolimus in patients with renal cancer on hemodialysis. J Clin Oncol. 26 (2008) 5652-5653 author reply
15. Lunardi G., Vannozzi M.O., Armirotti A., et al. Temsirolimus in patients with renal cancer on hemodialysis. J Clin Oncol. 26 (2008) 5653-5654
16. Boni J.P., Leister C., Bender G., et al. Population pharmacokinetics of CCI-779: Correlations to safety and pharmacogenomic responses in patients with advanced renal cancer. Clin Pharmacol Ther. 77 (2005) 76-89
17. Gibaldi M., and Perrier D. Pharmacokinetics. 2nd ed. (1982), Marcel Dekker, New York, NY
18. Escudier B., Eisen T., Stadler W.M., et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 356 (2007) 125-134
19. Motzer R.J., Hutson T.E., Tomczak P., et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma [published correction appears in N Engl J Med. 2007;357:203]. N Engl J Med. 356 (2007) 115-124
20. Rey P.M., and Villavicencio H. Sorafenib: Tolerance in patients on chronic hemodialysis: A single-center experience. Oncology. 74 (2008) 245-246
21. Guidance for industry pharmacoki-netics in patients with impaired renal function: Study design, data analysis, and impact on dosing and labeling (May 2003). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072127.pdf Accessed August 4, 2009