Temsirolimus for advanced renal cell carcinoma

Expert Review of Anticancer Therapy

Volumn 14, Issue 1, 2014, Pages 9-21

  Bergmann, Lothar ^a   Maute, Luise ^a   Guschmann, Michael ^b  

^a GOETHE UNIVERSITY   (Germany)

^b Institut fur Pharmakologie und Praventive Medizin   (Germany)

Author keywords

carcinoma; mTOR targeting therapy; renal; temsirolimus

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA INTERFERON; ASPARTATE AMINOTRANSFERASE; AXITINIB; BEVACIZUMAB; CREATININE; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DIPHENHYDRAMINE; HISTAMINE H1 RECEPTOR ANTAGONIST; KETOCONAZOLE; MAMMALIAN TARGET OF RAPAMYCIN; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; PAZOPANIB; PHENOBARBITAL; PHENYTOIN; PROTEIN SERINE THREONINE KINASE; RIFAMPICIN; SORAFENIB; SUNITINIB; TEMSIROLIMUS; VASCULOTROPIN; VASCULOTROPIN RECEPTOR;

ABDOMINAL PAIN; ACNE; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANAPHYLAXIS; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; APHTHOUS ULCER; APNEA; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; CANCER PROGNOSIS; CLEAR CELL CARCINOMA; CONTINUOUS INFUSION; COUGHING; CREATININE BLOOD LEVEL; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG PROTEIN BINDING; DRUG STRUCTURE; DRUG TARGETING; DRY SKIN; DYSPNEA; ENZYME INHIBITION; FLUSHING; FOOD AND DRUG ADMINISTRATION; G1 PHASE CELL CYCLE CHECKPOINT; GLOSSITIS; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERLIPIDEMIA; HYPOTENSION; KIDNEY CARCINOMA; MAXIMUM PLASMA CONCENTRATION; MOUTH ULCER; MUCOSA INFLAMMATION; MULTICENTER STUDY (TOPIC); NAUSEA; NEUTROPENIA; OPPORTUNISTIC INFECTION; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PRACTICE GUIDELINE; PROGRESSION FREE SURVIVAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RECOMMENDED DRUG DOSE; STOMATITIS; THORAX PAIN; THROMBOCYTOPENIA; UNITED STATES; UNSPECIFIED SIDE EFFECT; VOMITING;

ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; DISEASE-FREE SURVIVAL; HUMANS; KIDNEY NEOPLASMS; MOLECULAR TARGETED THERAPY; PROGNOSIS; PROTEIN KINASE INHIBITORS; SIROLIMUS; SURVIVAL RATE; TOR SERINE-THREONINE KINASES;

EID: 84893094184     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/14737140.2014.864562     Document Type: Article

References (88)

1. Chow WH, Devesa SS, Warren JL, Fraumeni JF Jr. Rising incidence of renal cell cancer in the United States. JAMA 281(17), 1628-1631 (1999
2. Escudier B, Albiges L, Sonpavde G. Optimal management of metastatic renal cell carcinoma: Current status. Drugs 73(5), 427-438 (2013
3. Mathew A, Devesa SS, Fraumeni JF Jr, Chow WH. Global increases in kidney cancer incidence, 1973-1992. Eur. J. Cancer Prev. 11(2), 171-178 (2002
4. Hollingsworth JM, Miller DC, Daignault S, Hollenbeck BK. Rising incidence of small renal masses: A need to reassess treatment effect. J. Natl Cancer Inst. 98(18), 1331-1334 (2006
5. Janzen NK, Kim HL, Figlin RA, Belldegrun AS. Surveillance after radical or partial nephrectomy for localized renal cell carcinoma and management of recurrent disease. Urol. Clin. North Am. 30(4), 843-852 (2003
6. Cho I, Chung J. Current status of targeted therapy for advanced renal cell carcinoma. Korean J. Urol. 53, 217-228 (2012
7. Dutcher JP, de Souza P, McDermott D et al. Effect of temsirolimus versus interferon-Alpha on outcome of patients with advanced renal cell carcinoma of different tumor histologies. Med. Oncol. 26(2), 202-209 (2009
8. Bukowski RM. Temsirolimus: A safety and efficacy review. Expert Opin. Drug Saf. 11(5), 861-879 (2012
9. Hanahan D, Weinberg RA. Hallmarks of cancer: The next generation. Cell 144(5), 646-674 (2011
10. Populo H, Lopes JM, Soares P. The mTOR Signalling Pathway in Human Cancer. Int. J. Mol. Sci. 13(2), 1886-1918 (2012
11. Faivre S, Kroemer G, Raymond E. Current development of mTOR inhibitors as anticancer agents. Nat. Rev. Drug Discov. 5(8), 671-688 (2006
12. Levine B, Kroemer G. Autophagy in the pathogenesis of disease. Cell 132(1), 27-42 (2008
13. Yuan R, Kay A, Berg WJ, Lebwohl D. Targeting tumorigenesis: Development and use of mTOR inhibitors in cancer therapy. J. Hematol. Oncol. 2, 45 (2009
14. Motzer RJ, Escudier B, Oudard S et al. Efficacy of everolimus in advanced renal cell carcinoma: A double-blind, randomised, placebo-controlled phase III trial. Lancet 372(9637), 449-456 (2008
15. Bergmann L, Goebell PJ, Kube U et al. Everolimus in metastatic renal cell carcinoma after failure of initial vascular endothelial growth factor receptor-Tyrosine kinase inhibitor (VEGFr-TKI) therapy: Results of an interim analysis of a non-interventional study. Onkologie 36(3), 95-100 (2013
16. Schmelzle T, Hall MN. TOR, a central controller of cell growth. Cell 103(2), 253-262 (2000
17. Fingar DC, Richardson CJ, Tee AR, Cheatham L, Tsou C, Blenis J. mTOR controls cell cycle progression through its cell growth effectors S6K1 and 4E-BP1/ eukaryotic translation initiation factor 4E. Mol. Cell. Biol. 24(1), 200-216 (2004
18. Harding MW. Immunophilins, mTOR, and pharmacodynamic strategies for a targeted cancer therapy. Clin. Cancer Res. 9(8), 2882-2886 (2003
19. Del Bufalo D, Ciuffreda L, Trisciuoglio D et al. Antiangiogenic potential of the Mammalian target of rapamycin inhibitor temsirolimus. Cancer Res. 66(11), 5549-5554 (2006
20. Molina AM, Motzer RJ. Clinical practice guidelines for the treatment of metastatic renal cell carcinoma: Today and tomorrow. Oncologist 16(Suppl. 2), 45-50 (2011
21. Beuvink I, Boulay A, Fumagalli S et al. The mTOR inhibitor RAD001 sensitizes tumor cells to DNA-damaged induced apoptosis through inhibition of p21 translation. Cell 120(6), 747-759 (2005
22. Shinohara ET, Cao C, Niermann K et al. Enhanced radiation damage of tumor vasculature by mTOR inhibitors. Oncogene 24(35), 5414-5422 (2005
23. Wu C, Wangpaichitr M, Feun L et al. Overcoming cisplatin resistance by mTOR inhibitor in lung cancer. Mol. Cancer 4(1), 25 (2005
24. Pantuck AJ, Seligson DB, Klatte T et al. Prognostic relevance of the mTOR pathway in renal cell carcinoma: Implications for molecular patient selection for targeted therapy. Cancer 109(11), 2257-2267 (2007
25. Patel PH, Chadalavada RS, Chaganti RS, Motzer RJ. Targeting von Hippel-Lindau pathway in renal cell carcinoma. Clin. Cancer Res. 12(24), 7215-7220 (2006
26. Dancey JE. Therapeutic targets: MTOR and related pathways. Cancer Biol. Ther. 5(9), 1065-1073 (2006
27. Sarbassov DD, Guertin DA, Ali SM, Sabatini DM. Phosphorylation and regulation of Akt/PKB by the rictor-mTOR complex. Science 307(5712), 1098-1101 (2005
28. Klumpen HJ, Beijnen JH, Gurney H, Schellens JH. Inhibitors of mTOR. Oncologist 15(12), 1262-1269 (2010
29. Guba M, von Breitenbuch P, Steinbauer M et al. Rapamycin inhibits primary and metastatic tumor growth by antiangiogenesis: Involvement of vascular endothelial growth factor. Nat. Med. 8(2), 128-135 (2002
30. Thomas GV, Tran C, Mellinghoff IK et al. Hypoxia-inducible factor determines sensitivity to inhibitors of mTOR in kidney cancer. Nat. Med. 12(1), 122-127 (2006
31. Hutson TE. Targeted therapies for the treatment of metastatic renal cell carcinoma: Clinical evidence. Oncologist 16(Suppl. 2), 14-22 (2011
32. Voss MH, Molina AM, Motzer RJ. mTOR inhibitors in advanced renal cell carcinoma. Hematol. Oncol. Clin. North Am. 25(4), 835-852 (2011
33. 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. 22(5), 909-918 (2004
34. Yatscoff R, LeGatt D, Keenan R, Chackowsky P. Blood distribution of rapamycin. Transplantation 56(5), 1202-1206 (1993
35. 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. 31(8), 1812-1819 (2009
36. Hidalgo M, Rowinsky EK. The rapamycin-sensitive signal transduction pathway as a target for cancer therapy. Oncogene 19(56), 6680-6686 (2000
37. 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(12), 2336-2347 (2004
38. Lunardi G, Vannozzi MO, Armirotti A, Nicodemo M, Venturini M, Cavallini L. Temsirolimus in patients with renal cancer on hemodialysis. J. Clin. Oncol. 26(34), 5652-5653, author reply 5653-5654 (2008
39. Eisen T, Sternberg CN, Robert C et al. Targeted therapies for renal cell carcinoma: Review of adverse event management strategies. J. Natl Cancer Inst. 104(2), 93-113 (2012
40. Hudes G, Carducci M, Tomczak P et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N. Engl. J. Med. 356(22), 2271-2281 (2007
41. Amato RJ, Jac J, Giessinger S, Saxena S, Willis JP. A phase 2 study with a daily regimen of the oral mTOR inhibitor RAD001 (everolimus) in patients with metastatic clear cell renal cell cancer. Cancer 115(11), 2438-2446 (2009
42. 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. 19(8), 1387-1392 (2008
43. Hadoux J, Vignot S, De La Motte Rouge T. Renal cell carcinoma: Focus on safety and efficacy of temsirolimus. Clin. Med. Insights Oncol. 4, 143-154 (2010
44. Launay-Vacher V, Oudard S, Janus N et al. Prevalence of Renal Insufficiency in cancer patients and implications for anticancer drug management: The renal insufficiency and anticancer medications (IRMA) study. Cancer 110(6), 1376-1384 (2007
45. Lee CK, Marschner IC, Simes RJ et al. Increase in cholesterol predicts survival advantage in renal cell carcinoma patients treated with temsirolimus. Clin. Cancer Res. 18(11), 3188-3196 (2012
46. Galanis E, Buckner JC, Maurer MJ et al. Phase II trial of temsirolimus (CCI-779) in recurrent glioblastoma multiforme: A North Central Cancer Treatment Group Study. J. Clin. Oncol. 23(23), 5294-5304 (2005
47. Teng CF, Wu HC, Tsai HW, Shiah HS, Huang W, Su IJ. Novel feedback inhibition of surface antigen synthesis by mammalian target of rapamycin (mTOR) signal and its implication for hepatitis B virus tumorigenesis and therapy. Hepatology 54(4), 1199-1207 (2011
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 98(11), 1797-1802 (2008
49. Boni J, Abbas R, Leister C et al. Disposition of desipramine, a sensitive cytochrome P450 2D6 substrate, when coadministered with intravenous temsirolimus. Cancer Chemother. Pharmacol. 64(2), 263-270 (2009
50. Dudkin L, Dilling MB, Cheshire PJ et al. Biochemical correlates of mTOR inhibition by the rapamycin ester CCI-779 and tumor growth inhibition. Clin. Cancer Res. 7(6), 1758-1764 (2001
51. Geoerger B, Kerr K, Tang CB et al. Antitumor activity of the rapamycin analog CCI-779 in human primitive neuroectodermal tumor/medulloblastoma models as single agent and in combination chemotherapy. Cancer Res. 61(4), 1527-1532 (2001
52. Shi Y, Gera J, Hu L et al. Enhanced sensitivity of multiple myeloma cells containing PTEN mutations to CCI-779. Cancer Res. 62(17), 5027-5034 (2002
53. Yu K, Toral-Barza L, Discafani C et al. mTOR, a novel target in breast cancer: The effect of CCI-779, an mTOR inhibitor, in preclinical models of breast cancer. Endocr. Relat. Cancer 8(3), 249-258 (2001
54. 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(19), 5755-5763 (2006
55. 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. 20(1), 289-296 (2002
56. Coppin C, Kollmannsberger C, Le L, Porzsolt F, Wilt TJ. Targeted therapy for advanced renal cell cancer (RCC): A Cochrane systematic review of published randomised trials. BJU Int. 108(10), 1556-1563 (2011
57. Zbrozek AS, Hudes G, Levy D et al. Q-TWiST analysis of patients receiving temsirolimus or interferon alpha for treatment of advanced renal cell carcinoma. Pharmacoeconomics 28(7), 577-584 (2010
58. Escudier B, Hutson T, Esteban E. Temsirolimus vs Sorafenib as Second Line Therapy in Metastatic Renal Cell Carcinoma: Results from the INTORSECT Trial. Proc. Euro. Soc. Med. Oncol. Congress Abstract LBA22 (2012
59. Hutson T, Escudier B, Esteban E et al. Temsirolimus vs Sorafenib as second line therapy in metastatic renal cell carcinoma: Results from the intersect trial. LBA22-PR (2012
60. Muller U, Krekeler G, Bergmann L, Steiner T, Kalanovic D. Evaluation of safety, tolerability and activity of temsirolimus in patients with advanced or metastatic renal cell carcinoma (a/mRCC) in the routine healthcare setting. ESMO (2012
61. Kovacs G, Akhtar M, Beckwith BJ et al. The Heidelberg classification of renal cell tumours. J. Pathol. 183(2), 131-133 (1997
62. Patard JJ, Leray E, Rioux-Leclercq N et al. Prognostic value of histologic subtypes in renal cell carcinoma: A multicenter experience. J. Clin. Oncol. 23(12), 2763-2771 (2005
63. Cheville JC, Lohse CM, Zincke H, Weaver AL, Blute ML. Comparisons of outcome and prognostic features among histologic subtypes of renal cell carcinoma. Am. J. Surg. Pathol. 27(5), 612-624 (2003
64. Albiges L, Molinie V, Escudier B
65. Zhuang Z, Park WS, Pack S et al. Trisomy 7-harbouring non-random duplication of the mutant MET allele in hereditary papillary renal carcinomas. Nat. Genet. 20(1), 66-69 (1998
66. Fischer J, Palmedo G, von Knobloch R et al. Duplication and overexpression of the mutant allele of the MET proto-oncogene in multiple hereditary papillary renal cell tumours. Oncogene 17(6), 733-739 (1998
67. Areses MC, Herranz UA, Ferran BB, Mateos LL, Gonzalez JG, Lopez RL. Temsirolimus in renal cell carcinoma with sarcomatoid differentiation: A report of three cases. Med. Oncol. 29(2), 795-798 (2012
68. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Kidney Cancer. Version I. 2013 (2013
69. Merchan J, Liu G, Fitch T. Phase I/II trial of CCI-779 and bevacizumab in stage IV renal cell carcinoma: Phase I safety and activity results. Proc. Am. Soc. Clin. Oncol. 25, Abstract 5034 (2007
70. Rini B, Bellmunt J, Clancy J. Randomized Phase IIIb Trial of temsirolimus and bevacizumab versus interferon and bevacizumab in metastatic renal cell carcinoma: Results from INTORACT. Proc. Eur. Soc. Med. Oncol. (2012
71. Negrier S, Gravis G, Perol D et al. Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): A randomised phase 2 trial. Lancet Oncol. 12(7), 673-680 (2011
72. 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 7(1), 24-27 (2009
73. Escudier B, Eisen T, Porta C et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 23 (Suppl. 7), vii65-vii71 (2012
74. Ljungberg B, Bensalah K, Bex A et al. Guidelines on Renal Cell Carcinoma. (2013
75. Najjar YG, Rini BI. Novel agents in renal carcinoma: A reality check. Ther. Adv. Med. Oncol. 4(4), 183-194 (2012
76. Mihaly Z, Sztupinszki Z, Surowiak P, Gyorffy B. A comprehensive overview of targeted therapy in metastatic renal cell carcinoma. Curr. Cancer Drug Targets 12(7), 857-872 (2012
77. Mackenzie MJ, Rini BI, Elson P et al. Temsirolimus in VEGF-refractory metastatic renal cell carcinoma. Ann. Oncol. 22(1), 145-148 (2011
78. Gross-Goupil M, Massard C, Ravaud A. Targeted therapies in metastatic renal cell carcinoma: Overview of the past year. Curr. Urol. Rep. 13(1), 16-23 (2012
79. Sun M, Shariat SF, Trinh QD et al. An evidence-based guide to the selection of sequential therapies in metastatic renal cell carcinoma. Ther. Adv. Urol. 5(2), 121-128 (2013
80. Bojanapally P, Graham S, Rustine. Temsirolimus for advanced renal cell carcinoma: Compassionate versus commercial use. J. Clin. Oncol. 26(Suppl.), Abstract 16139 (2008
81. Schmidinger M, Vogel U, Lamm W. Temsirolimus in heavily pre-Treated patients with metastatic renal cell carcinoma: Preliminary results from the Austrian Compassionate Use Program. J. Clin. Oncol. 26(Suppl.), Abstract 16125) (2008
82. Takayama T, Furuse H, Kai F, Sugiyama T, Ozono S. Temsirolimus controlled metastatic advanced renal cell carcinoma for over 4 years: A case study. Med. Oncol. 30(2), 563 (2013
83. Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J. Clin. Oncol. 17(8), 2530-2540 (1999
84. 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. 28(13), 2144-2150 (2010
85. 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. 27(22), 3584-3590 (2009
86. Escudier B, Goupil MG, Massard C, Fizazi K. Sequential therapy in renal cell carcinoma. Cancer 115(10 Suppl.), 2321-2326 (2009
87. Di Lorenzo G, Porta C, Bellmunt J et al. Toxicities of targeted therapy and their management in kidney cancer. Eur. Urol. 59(4), 526-540 (2011
88. Ravaud A. Treatment-Associated adverse event management in the advanced renal cell carcinoma patient treated with targeted therapies. Oncologist 16(Suppl. 2), 32-44 (2011