Phase I trial of lenalidomide and CCI-779 in patients with relapsed multiple myeloma: Evidence for lenalidomide-CCI-779 interaction via P-glycoprotein

Journal of Clinical Oncology

Volumn 29, Issue 25, 2011, Pages 3427-3434

  Hofmeister, Craig C ^a   Yang, Xiaoxia ^a   Pichiorri, Flavia ^a   Chen, Ping ^a   Rozewski, Darlene M ^a   Johnson, Amy J ^a   Lee, Seungsoo ^a   Liu, Zhongfa ^a   Garr, Celia L ^a   Hade, Erinn M ^a   Ji, Jia ^a   Schaaf, Larry J ^a   Benson Jr , Don M ^a   Kraut, Eric H ^a   Hicks, William J ^a   Chan, Kenneth K ^a   Chen, Ching Shih ^a   Farag, Sherif S ^b   Grever, Michael R ^a   Byrd, John C ^a   Phelps, Mitch A ^a   more..

^a THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^b INDIANA UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLYCOPROTEIN P; LENALIDOMIDE; MULTIDRUG RESISTANCE PROTEIN 1; TEMSIROLIMUS;

ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CANCER RELAPSE; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DIZZINESS; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG TRANSPORT; DRUG UPTAKE; FATIGUE; FEBRILE NEUTROPENIA; HUMAN; HUMAN CELL; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERTRIGLYCERIDEMIA; HYPOKALEMIA; HYPOPHOSPHATEMIA; INFECTION; INSOMNIA; LYMPHOCYTOPENIA; MAXIMUM TOLERATED DOSE; MULTIPLE MYELOMA; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; TASTE DISORDER; THROMBOCYTOPENIA;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLOTTING, WESTERN; DRUG INTERACTIONS; HUMANS; MAXIMUM TOLERATED DOSE; MULTIPLE MYELOMA; NEOPLASM RECURRENCE, LOCAL; P-GLYCOPROTEIN; SIROLIMUS; SURVIVAL RATE; THALIDOMIDE; TISSUE DISTRIBUTION; TREATMENT OUTCOME;

EID: 80052756653     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.32.4962     Document Type: Article

References (45)

1. Peterson TR, Laplante M, Thoreen CC, et al: DEPTOR is an mTOR inhibitor frequently overexpressed in multiple myeloma cells and required for their survival. Cell 137:873-886, 2009
2. Baumann P, Mandl-Weber S, Oduncu F, et al: The novel orally bioavailable inhibitor of phosphoinositol-3-kinase and mammalian target of rapamycin, NVP-BEZ235, inhibits growth and proliferation in multiple myeloma. Exp Cell Res 315:485-497, 2009
3. Frost P, Shi Y, Hoang B, et al: AKT activity regulates the ability of mTOR inhibitors to prevent angiogenesis and VEGF expression in multiple myeloma cells. Oncogene 26:2255-2262, 2007 (Pubitemid 46572812)
4. Stromberg T, Dimberg A, Hammarberg A, et al: Rapamycin sensitizes multiple myeloma cells to apoptosis induced by dexamethasone. Blood 103:3138-3147, 2004 (Pubitemid 38451692)
5. Dancey JE: Molecular targeting: PI3 kinase pathway. Ann Oncol 15:iv233-iv239, 2004 (suppl 4)
6. Vivanco I, Sawyers CL: The phosphatidylinositol 3-Kinase AKT pathway in human cancer. Nat Rev Cancer 2:489-501, 2002 (Pubitemid 37328931)
7. Gera JF, Mellinghoff IK, Shi Y, et al: AKT activity determines sensitivity to mammalian target of rapamycin (mTOR) inhibitors by regulating cyclin D1 and c-myc expression. J Biol Chem 279:2737-2746, 2004 (Pubitemid 38114263)
8. Shi Y, Gera J, Hu L, et al: Enhanced sensitivity of multiple myeloma cells containing PTEN mutations to CCI-779. Cancer Res 62:5027-5034, 2002 (Pubitemid 34984430)
9. Frost P, Moatamed F, Hoang B, et al: In vivo antitumor effects of the mTOR inhibitor CCI-779 against human multiple myeloma cells in a xenograft model. Blood 104:4181-4187, 2004 (Pubitemid 39620172)
10. Bladé J, Samson D, Reece D, et al: Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation: Myeloma Subcommittee of the EBMT - European Group for Blood and Marrow Transplant. Br J Haematol 102:1115-1123, 1998 (Pubitemid 28435189)
11. Bonkowski J, Vermeulen LC, Kolesar JM: The clinical utility of lenalidomide in multiple myeloma and myelodysplastic syndromes. J Oncol Pharm Pract 16:223-232, 2010
12. Galustian C, Dalgleish A: Lenalidomide: A novel anticancer drug with multiple modalities. Expert Opin Pharmacother 10:125-133, 2009
13. Hazarika M, Rock E, Williams G, et al: Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy. Oncologist 13:1120-1127, 2008
14. Raje N, Kumar S, Hideshima T, et al: Combination of the mTOR inhibitor rapamycin and CC-5013 has synergistic activity in multiple myeloma. Blood 104:4188-4193, 2004 (Pubitemid 39620173)
15. Durie BG, Harousseau JL, Miguel JS, et al: International uniform response criteria for multiple myeloma. Leukemia 20:1467-1473, 2006 (Pubitemid 44264086)
16. Liu Q, Farley KL, Johnson AJ, et al: Development and validation of a highly sensitive liquid chromatography/mass spectrometry method for simultaneous quantification of lenalidomide and flavopiridol in human plasma. Ther Drug Monit 30:620-627, 2008
17. Cockcroft D, Gault M: Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41, 1976
18. Lapalombella R, Yu B, Triantafillou G, et al: Lenalidomide down-regulates the CD20 antigen and antagonizes direct and antibody-dependent cellular cytotoxicity of rituximab on primary chronic lymphocytic leukemia cells. Blood 112:5180-5189, 2008
19. Farag SS, Zhang S, Jansak BS, et al: Phase II trial of temsirolimus in patients with relapsed or refractory multiple myeloma. Leuk Res 33:1475-1480, 2009
20. Dahut WL, Aragon-Ching JB, Woo S, et al: Phase I study of oral lenalidomide in patients with refractory metastatic cancer. J Clin Pharmacol 49:650-660, 2009
21. Chen N, Lau H, Kong L, et al: Pharmacokinetics of lenalidomide in subjects with various degrees of renal impairment and in subjects on hemodialysis. J Clin Pharmacol 47:1466-1475, 2007 (Pubitemid 350115306)
22. Hidalgo M, Buckner JC, Erlichman C, et al: A phase I and pharmacokinetic study of temsirolimus (CCI-779) administered intravenously daily for 5 days every 2 weeks to patients with advanced cancer. Clin Cancer Res 12:5755-5763, 2006 (Pubitemid 44629606)
23. Boni JP, 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 77:76-89, 2005 (Pubitemid 40075391)
24. Chang SM, Kuhn J, Wen P, et al: Phase I/pharmacokinetic study of CCI-779 in patients with recurrent malignant glioma on enzyme-inducing antiepileptic drugs. Invest New Drugs 22:427-435, 2004 (Pubitemid 39619819)
25. Kumar G, Lau H, Laskin O: Lenalidomide: In vitro evaluation of the metabolism and assessment of cytochrome P450 inhibition and induction. Cancer Chemother Pharmacol 63:1171-1175, 2009
26. Arceci RJ, Stieglitz K, Bierer BE: Immunosuppressants FK506 and rapamycin function as reversal agents of the multidrug resistance phenotype. Blood 80:1528-1536, 1992
27. Hoof T, Demmer A, Christians U, et al: Reversal of multidrug resistance in Chinese hamster ovary cells by the immunosuppressive agent rapamycin. Eur J Pharmacol 246:53-58, 1993 (Pubitemid 23178333)
28. Lampen A, Zhang Y, Hackbarth I, et al: Metabolism and transport of the macrolide immunosuppressant sirolimus in the small intestine. J Pharmacol Exp Ther 285:1104-1112, 1998 (Pubitemid 28277909)
29. Sattler M, Guengerich FP, Yun CH, et al: Cytochrome P-450 3A enzymes are responsible for biotransformation of FK506 and rapamycin in man and rat. Drug Metab Dispos 20:753-761, 1992
30. Fine HA, Kim L, Albert PS, et al: A phase I trial of lenalidomide in patients with recurrent primary central nervous system tumors. Clin Cancer Res 13:7101-7106, 2007 (Pubitemid 350276894)
31. Drug information for Revlimid (lenalidomide): Application No. (NDA) 021880. US Food and Drug Administration Drug Approvals and Databases, December 2005
32. Tucci M, Quatraro C, Dammacco F, et al: Role of active drug transporters in refractory multiple myeloma. Curr Top Med Chem 9:218-224, 2009
33. Yang HH, Ma MH, Vescio RA, et al: Overcoming drug resistance in multiple myeloma: The emergence of therapeutic approaches to induce apoptosis. J Clin Oncol 21:4239-4247, 2003 (Pubitemid 46606195)
34. Huang YW, Hamilton A, Arnuk OJ, et al: Current drug therapy for multiple myeloma. Drugs 57:485-506, 1999 (Pubitemid 29196917)
35. Sonneveld P: Drug resistance in multiple myeloma. Pathol Biol (Paris) 47:182-187, 1999
36. Pilarski LM, Mant MJ, Belch AR: Drug resistance in multiple myeloma: Novel therapeutic targets within the malignant clone. Leuk Lymphoma 32:199-210, 1999 (Pubitemid 29087802)
37. Sonneveld P, Durie BG, Lokhorst HM, et al: Modulation of multidrug-resistant multiple myeloma by cyclosporine: The Leukaemia Group of the EORTC and the HOVON. Lancet 340:255-259, 1992
38. Jakubikova J, Adamia S, Kost-Alimova M, et al: Lenalidomide targets clonogenic side population in multiple myeloma: Pathophysiologic and clinical implications. Blood 117:4409-4419, 2011
39. Mark PJ, Waddell BJ: P-glycoprotein restricts access of cortisol and dexamethasone to the glucocorticoid receptor in placental BeWo cells. Endocrinology 147:5147-5152, 2006 (Pubitemid 44790568)
40. Ueda K, Okamura N, Hirai M, et al: Human P-glycoprotein transports cortisol, aldosterone, and dexamethasone, but not progesterone. J Biol Chem 267:24248-24252, 1992
41. Perloff MD, Von Moltke LL, Greenblatt DJ: Ritonavir and dexamethasone induce expression of CYP3A and P-glycoprotein in rats. Xenobiotica 34: 133-150, 2004 (Pubitemid 38299715)
42. Lin JH, Chiba M, Chen IW, et al: Effect of dexamethasone on the intestinal first-pass metabolism of indinavir in rats: Evidence of cytochrome P-450 3A [correction of P-450 A] and p-glycoprotein induction. Drug Metab Dispos 27:1187-1193, 1999 (Pubitemid 29463606)
43. Chieli E, Santoni-Rugiu E, Cervelli F, et al: Differential modulation of P-glycoprotein expression by dexamethasone and 3-methylcholanthrene in rat hepatocyte primary cultures. Carcinogenesis 15:335-341, 1994 (Pubitemid 24121671)
44. Fardel O, Lecureur V, Guillouzo A: Regulation by dexamethasone of P-glycoprotein expression in cultured rat hepatocytes. FEBS Lett 327:189-193, 1993 (Pubitemid 23211186)
45. Micuda S, Fuksa L, Mundlova L, et al: Morphological and functional changes in P-glycoprotein during dexamethasone-induced hepatomegaly. Clin Exp Pharmacol Physiol 34:296-303, 2007