Renal cell carcinoma: Focus on safety and efficacy of temsirolimus

Clinical Medicine Insights: Oncology

Volumn 4, Issue , 2010, Pages 143-154

  Hadoux, Julien ^a   Vignot, Stephane ^a   Rouge, Thibault de la Motte ^a  

^a PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

Author keywords

Clear cell carcinoma; Efficacy; mTOR; Rapamycin; Safety; Temsirolimus

Indexed keywords

ALPHA INTERFERON; ANTIBIOTIC AGENT; BEVACIZUMAB; CARBONATE DEHYDRATASE; KETOCONAZOLE; PHOSPHATIDYLINOSITOL 3,4,5 TRISPHOSPHATE 3 PHOSPHATASE; RAPAMYCIN; S6 KINASE; SORAFENIB; SUNITINIB; TEMSIROLIMUS; VON HIPPEL LINDAU PROTEIN;

ACNE; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BLOOD TOXICITY; CANCER IMMUNOTHERAPY; CARCINOGENESIS; CATABOLISM; CELL PROLIFERATION; CELLULITIS; CONSTIPATION; COUGHING; DIARRHEA; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ERUPTION; DRUG EXCRETION; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED DISEASE; DRUG MEGADOSE; DRUG METABOLISM; DRUG POTENCY; DRUG POTENTIATION; DRUG SAFETY; DRUG SOLUBILITY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; GLOMERULOPATHY; GLOMERULOSCLEROSIS; GLUCOSE BLOOD LEVEL; GOUT; HAND FOOT SYNDROME; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERLIPIDEMIA; HYPERTRIGLYCERIDEMIA; HYPOPHOSPHATEMIA; KIDNEY CARCINOMA; KIDNEY FUNCTION; LEUKOPENIA; MACULOPAPULAR RASH; MAXIMUM PLASMA CONCENTRATION; MUCOCUTANEOUS TOXICITY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVERALL SURVIVAL; PHARMACODYNAMICS; PNEUMONIA; PROGRESSION FREE SURVIVAL; PROTEIN MODIFICATION; PROTEIN PHOSPHORYLATION; PROTEIN SYNTHESIS; PROTEINURIA; PRURITUS; RECTUM HEMORRHAGE; REVIEW; SIDE EFFECT; SIGNAL TRANSDUCTION; STOMATITIS; THROMBOCYTOPENIA; TUMOR GROWTH; TYPHLITIS; VOMITING;

EID: 79851489474     PISSN: 11795549     EISSN: 11795549     Source Type: Journal    
DOI: 10.4137/CMO.S4482     Document Type: Review

References (48)

1. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009;59(4):225-49.
2. Aass N, De Mulder PH, Mickisch GH, et al. Randomized phase II/III trial of interferon Alfa-2a with and without 13-cis-retinoic acid in patients with progressive metastatic renal cell Carcinoma: the European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951). J Clin Oncol. 2005;20;23(18):4172-8.
3. Fossa SD, Martinelli G, Otto U, et al. Recombinant interferon alfa-2a with or without vinblastine in metastatic renal cell carcinoma: results of a European multi-center phase III study. Ann Oncol. 1992;3(4):301-5.
4. Minasian LM, Motzer RJ, Gluck L, Mazumdar M, Vlamis V, Krown SE. Interferon alfa-2a in advanced renal cell carcinoma: treatment results and survival in 159 patients with long-term follow-up. J Clin Oncol. 1993;11(7):1368-75.
5. Muss HB, Costanzi JJ, Leavitt R, et al. Recombinant alfa interferon in renal cell carcinoma: a randomized trial of two routes of administration. J Clin Oncol. 1987;5(2):286-91.
6. Negrier S, Escudier B, Lasset C, et al. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie. N Engl J Med. 1998;338(18):1272-8.
7. Otto U, Schneider AW, Conrad S, Klosterhalfen H. Recombinant alpha-2 or gamma interferon in the treatment of metastatic renal cell carcinoma: results of two phase II/III trials. Prog Clin Biol Res. 1990;350:275-82.
8. Atkins MB, Sparano J, Fisher RI, et al. Randomized phase II trial of highdose interleukin-2 either alone or in combination with interferon alfa-2b in advanced renal cell carcinoma. J Clin Oncol. 1993;11(4):661-70.
9. McDermott DF, Regan MM, Clark JI, et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol. 2005;23(1):133-41.
10. Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007;356(2):115-24.
11. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356(2):125-34.
12. Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007;370(9605):2103-11.
13. Rini BI, Halabi S, Rosenberg JE, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol. 2008;20;26(33):5422-8.
14. Motzer RJ, Hutson TE, Tomczak P, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009;27(22):3584-90.
15. Escudier B, Eisen T, Stadler WM, et al. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009;27(20):3312-8.
16. Escudier B, Bellmunt J, Negrier S, et al. Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol. 2010;28(13):2144-50.
17. Rini BI, Halabi S, Rosenberg JE, et al. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol. 2010;28(13):2137-43.
18. Baldo P, Cecco S, Giacomin E, Lazzarini R, Ros B, Marastoni S. mTOR pathway and mTOR inhibitors as agents for cancer therapy. Curr Cancer Drug Targets. 2008;8(8):647-65.
19. Vignot S, Faivre S, Aguirre D, Raymond E. mTOR-targeted therapy of cancer with rapamycin derivatives. Ann Oncol. 2005;16(4):525-37.
20. Hudes GR, Berkenblit A, Feingold J, Atkins MB, Rini BI, Dutcher J. Clinical trial experience with temsirolimus in patients with advanced renal cell carcinoma. Semin Oncol. 2009;36 Suppl 3:S26-36.
21. Faivre S, Kroemer G, Raymond E. Current development of mTOR inhibitors as anticancer agents. Nat Rev Drug Discov. 2006;5(8):671-88.
22. Boni JP, Hug B, Leister C, Sonnichsen D. Intravenous temsirolimus in cancer patients: clinical pharmacology and dosing considerations. Semin Oncol. 2009;36 Suppl 3:S18-25.
23. Le TC, Faivre S, Serova M, Raymond E. mTORC1 inhibitors: is temsirolimus in renal cancer telling us how they really work? Br J Cancer. 2008;99(8):1197-203.
24. Park IH, Bachmann R, Shirazi H, Chen J. Regulation of ribosomal S6 kinase 2 by mammalian target of rapamycin. J Biol Chem. 2002;277(35):31423-9.
25. Wullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism. Cell. 2006;124(3):471-84.
26. Thomas GV, Tran C, Mellinghoff IK, et al. Hypoxia-inducible factor determines sensitivity to inhibitors of mTOR in kidney cancer. Nat Med. 2006;12(1):122-7.
27. 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. 2005;77(1):76-89.
28. 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. 2004;22(4):427-35.
29. Punt CJ, Boni J, Bruntsch U, Peters M, Thielert C. Phase I and pharmacokinetic study of CCI-779, a novel cytostatic cell-cycle inhibitor, in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors. Ann Oncol. 2003;14(6):931-7.
30. 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. 2004;22(12):2336-47.
31. Lunardi G, Armirotti A, Nicodemo M, et al. Comparison of temsirolimus pharmacokinetics in patients with renal cell carcinoma not receiving dialysis and those receiving hemodialysis: a case series. Clin Ther. 2009;31(8):1812-9.
32. Atkins MB, Hidalgo M, Stadler WM, et al. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol. 2004;22(5):909-18.
33. 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. 2006;12(19):5755-63.
34. Motzer RJ, Bacik J, Mazumdar M. Prognostic factors for survival of patients with stage IV renal cell carcinoma: memorial sloan-kettering cancer center experience. Clin Cancer Res. 2004;10(18 Pt 2):6302S-3.
35. Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002;20(1):289-96.
36. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356(22):2271-81.
37. Motzer RJ, Hudes GR, Curti BD, et al. Phase I/II trial of temsirolimus combined with interferon alfa for advanced renal cell carcinoma. J Clin Oncol. 2007;25(25):3958-64.
38. Patel PH, Senico PL, Curiel RE, Motzer RJ. Phase I study combining treatment with temsirolimus and sunitinib malate in patients with advanced renal cell carcinoma. Clin Genitourin Cancer. 2009;7(1):24-7.
39. Patnaik A, Ricart A, Cooper J, et al. A phase I, pharmacokinetic and pharmacodynamic study of sorafenib (S), a multi-targeted kinase inhibitor in combination with temsirolimus (T), an mTOR inhibitor in patients with advanced solid malignancies. J Clin Oncol. (Meeting Abstracts) 2007;25(18_Suppl):3512.
40. Escudier BJ, Negrier S, Gravis G, et al. Can the combination of temsirolimus and bevacizumab improve the treatment of metastatic renal cell carcinoma (mRCC)? Results of the randomized TORAVA phase II trial. J Clin Oncol. (Meeting Abstracts) 2010;28(15_Suppl):4516.
41. Cho D, Signoretti S, Dabora S, et al. Potential histologic and molecular predictors of response to temsirolimus in patients with advanced renal cell carcinoma. Clin Genitourin Cancer. 2007;5(6):379-85.
42. Peralba JM, DeGraffenried L, Friedrichs W, et al. Pharmacodynamic Evaluation of CCI-779, an Inhibitor of mTOR, in Cancer Patients. Clin Cancer Res. 2003;9(8):2887-92.
43. Figlin RA, de SP, McDermott D, et al. Analysis of PTEN and HIF-1alpha and correlation with efficacy in patients with advanced renal cell carcinoma treated with temsirolimus versus interferon-alpha. Cancer. 2009;115(16):3651-60.
44. Bellmunt J, Szczylik C, Feingold J, Strahs A, Berkenblit A. Temsirolimus safety profile and management of toxic effects in patients with advanced renal cell carcinoma and poor prognostic features. Ann Oncol. 2008;19(8):1387-92.
45. Izzedine H, Boostandoot E, Spano JP, Bardier A, Khayat D. Temsirolimusinduced glomerulopathy. Oncology. 2009;76(3):170-2.
46. Morelon E, Stern M, Israel-Biet D, et al. Characteristics of sirolimus- associated interstitial pneumonitis in renal transplant patients. Transplantation. 2001;72(5):787-90.
47. Duran I, Siu LL, Oza AM, et al. Characterisation of the lung toxicity of the cell cycle inhibitor temsirolimus. Eur J Cancer. 2006;42(12):1875-80.
48. Boni JP, Leister C, Burns J, Hug B. Differential effects of ketoconazole on exposure to temsirolimus following intravenous infusion of temsirolimus. Br J Cancer. 2008;98(11):1797-802.