78
Views
3
CrossRef citations to date
0
Altmetric
Review

Everolimus: the first approved product for patients with advanced renal cell cancer after sunitinib and/or sorafenib

Pages 91-101 | Published online: 30 Apr 2010

References

  • Canadian Cancer Society’s Steering CommitteeCanadian Cancer Statistics 2009TorontoCanadian Cancer Society2009 www.cancer.ca/statistics Accessed Nov 30, 2009.
  • JemalASiegalRWardEHaoYXuJThunMJCancer statistics, 2009Ca Cancer J Clin20085922524919474385
  • MooreLEWilsonRTLifestyle factors, exposures, genetic susceptibility, and renal cell cancer risk: a reviewCancer Invest20052324025515945510
  • British Columbia Cancer Registry Potential years of life lost. BC Cancer Agency, Vancouver BC, Canada. www.bccancer.bc.ca/HPI/CancerStatistics/FF/LifeLost.htm Accessed Nov 30, 2009.
  • MotzerRJBacikJMurphyBARussoPMazumdarMInterferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinomaJ Clin Oncol20022028929611773181
  • MekhailTMAbou-JawdeRMBouMerhiGValidation and extension of the Memorial Sloan-Kettering prognostic factors model for survival in patients with previously untreated metastatic renal cell carcinomaJ Clin Oncol20052383284115681528
  • Medical Council Renal Cancer CollaboratorsInterferon-α and survival in metastatic renal carcinoma: early results of a randomized controlled trialLancet1999353141710023944
  • FiglinRAHutsonTETomczakPOverall survival with sunitinib versus interferon-alfa as first-line treatment of metastatic renal cell carcinomaJ Clin Oncol200826suppl:abstr 5024. Abstract and associated presentation available from http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_meeting_categories_view&confID=55 Accessed Nov 30, 2009.
  • CoppinCPorzsoltFAutenreithMKumpfJColdmanAWiltTImmunotherapy for advanced renal cell cancerCochrane Database Syst Rev20043CD001425, updated 18 May, 2006.
  • CoppinCLeLPorzsoltFWiltTTargeted therapy for advanced renal cell cancerCochrane Database Syst Rev20082CD00601718425931
  • GleaveMEElhilaliMFradetYInterferon gamma-1b compared with placebo in metastatic renal-cell carcinomaN Engl J Med1998338126512719562580
  • RavaudAHawkinsRGardnerJLapatinib versus hormone therapy in patients with advanced renal cell carcinoma: a randomized phase III clinical trialJ Clin Oncol2008262285229118467719
  • FyfeGFisherRIRosenbergSASznolMParkinsonDRLouieACResults of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapyJ Clin Oncol1995136886967884429
  • PyrhonenSSalminenERuutuMProspective randomized trial of interferon alfa-2a plus vinblastine versus vinblastine alone in patients with advanced renal cell cancerJ Clin Oncol1999172859286710561363
  • RiniBICambellSCEscudierBRenal cell carcinomaLancet20093731119113219269025
  • RiniBIMetastatic renal cell carcinoma: many treatment options, one patientJ Clin Oncol2009273225323419470934
  • MotzerRJHutsonTETomczakPOverall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinomaJ Clin Oncol2009273584359019487381
  • EscudierBEisenTStadlerWMSorafenib in advanced clear-cell renal-cell carcinomaN Engl J Med200735612513417215530
  • BracardaSPatardJRavaudACurrent perspectives in metastatic renal cell carcinoma treatment: the role of mammalian target of rapamycin (mTOR) inhibitionEur Urol Suppl20098785786
  • HudesGCarducciMTomczakPTemsirolimus, interferon alfa, or both for advanced renal-cell carcinomaN Engl J Med20073562271228117538086
  • VezinaCKudelskiASehgalSNRapamycin (AY-22,989), a new antifungal antibiotic. I. Taxonomy of the producing Streptomycete and isolation of the active principleJ Antibiot (Tokyo)1975287217261102508
  • CalneRYLimSSamaanARapamycin for immunosuppression in organ allograftingLancet198922272568561
  • StrimpakosASKarapanagiotouEMSaifMWSyrigosKNThe role of mTOR in the management of solid tumors: an overviewCancer Treat Rev20093514815919013721
  • HarrisonDEStrongRSharpZDRapamycin fed late in life extends lifespan in genetically heterogeneous miceNature200946039239619587680
  • HuangSBjornstiMHoughtonPJRapamycins. Mechanism of action and cellular resistenceCancer Biol Ther2003222223212878853
  • HudesGRTargeting mTOR in renal cell carcinomaCancer200911510 Suppl2313232019402072
  • HayNSonenbergNUpstream and downstream of mTORGenes Dev2004181926194515314020
  • SabatiniDMmTOR and cancer: insights into a complex relationshipNat Rev Cancer2006672973416915295
  • AbrahamRTGibbonsJJThe mammalian target of rapamycin signaling pathway: twists and turns in the road to cancer therapyClin Cancer Res2007133109311417545512
  • HannaSCHeathcoteSAKimWYmTOR pathway in renal cell carcinomaExpert Rev Anticancer Ther2008828329218279068
  • ChoiJChenJSchreiberSLClardyJStructure of the FKBP12-rapamycin complex interacting with the binding domain of human FRAPScience19962732392428662507
  • LaneHAWoodJMMcSheehyPMJmTOR inhibitor RAD001 (everolimus) has antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitorClin Cancer Res2009151612162219223496
  • ManegoldPCParingerCKulkaUAntiangiogenic therapy with mammalian target of rapamycin inhibitor RAD001 (everolimus) increases radiosensitivity in solid cancerClin Cancer Res20081489290018245553
  • RiniBIAtkinsMBResistance to targeted therapy in renal-cell carcinomaLancet Oncol200910992100019796751
  • O’ReillyKERojoFSheQmTOR inhibition induces upstream receptor kinase signaling and activates AktCancer Res2006661500150816452206
  • ToschiALeeEGadirNOhhMFosterDADifferential dependence of hypoxia-inducible factors 1α and 2α on mTORC1 and mTORC2J Biol Chem2008283344953449918945681
  • HardingMWImmunophilins, mTOR, and pharmacodynamic strategies for a targeted cancer therapyClin Cancer Res200392882288612912931
  • BoulayAZumstein-MeckerSStephanCAntitumor efficacy of intermittent treatment schedules with the rapamycin derivative RAD001 correlates with prolonged inactivation of ribosomal protein S6 kinase 1 in perpheral blood mononuclear cellsCancer Res20046425226114729632
  • TaberneroJRojoFCalvoEDose- and schedule-dependent inhibition of the mammalian target of rapamycin pathway with everolimus: a phase I tumor pharmacodynamic study in patients with advanced solid tumorsJ Clin Oncol2008261603161018332469
  • O’DonnellAFaivreSBurrisHAPhase I pharmacokinetic and pharmacodynamic study of the oral mammalian target of rapamycin inhibitor everolimus in patients with advanced solid tumorsJ Clin Oncol2008261588159518332470
  • TanakaCO’ReillyTKovarikJMIdentifying optimal biological doses of everolimus (RAD001) in patients with cancer based on the modeling of preclinical and clinical pharmacokinetic and pharmacodynamic dataJ Clin Oncol2008261596160218332467
  • TaberneroJRojoFBurrisHA phase I study with tumor molecular pharmacodynamic (MPD) evaluation of dose and schedule of the oral mTOR-inhibitor Everolimus (RAD001) in patients (pts) with advanced solid tumorsJ Clin Oncol200523suppl:abstr 3007.
  • StromTHaschkeMZhangYLIdentification of everolimus metabolite patterns in trough blood samples of kidney transplant patientsTher Drug Monit20072959259917898649
  • European summary of product characteristics: Afinitor 10 mg. Novartis global. http://www.afinitor.com/global/docs/Afinitor-CD-EN-10mg.pdf Accessed Nov 30, 2009.
  • AmatoRJJacJGiessingerSSaxenaSWillisJPA phase 2 study with a daily regimen of the oral mTOR inhibitor RAD001 (everolimus) in patients with metastatic clear cell renal cell cancerCancer20091152438244619306412
  • JacJAmatoRJGiessingerSSaxenaSWillisJPA phase II study with a daily regimen of the oral mTOR inhibitor RAD001 (everolimus) in patients with metastatic renal cell carcinoma which has progressed on tyrosine kinase inhibition therapyJ Clin Oncol200826suppl;abstr 5113.
  • MotzerRJEscudierBOudardSEfficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trialLancet200837244945618653228
  • KayAMotzerRFiglinRUpdated data from a phase III randomized trial of everolimus (RAD001) versus PBO in metastatic renal cell carcinomaAmerican Society of Clinical Oncology Genitourinary Cancers Symposium2009;abstr 278. Abstract and associated presentation by RJ Motzer available from http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_meeting_categories_view&confID=64 Accessed Nov 30, 2009.
  • MotzerRJBacikJSchwartzLHPrognostic factors for survival in previously treated patients with metastatic renal cell carcinomaJ Clin Oncol20042245446314752067
  • TherassePArbuckSGEisenhauerEANew guidelines to evaluate the response to treatment in solid tumorsJ Natl Cancer Inst20009220521610655437
  • KnoxJJProgression-free survival as endpoint in metastatic RCC?Lancet200837242742918653227
  • DeleaTKhuuAKayAZhengJBaladiJFAssociation between time to disease progression endpoints and overall survival in patients with meta-static renal cell carcinomaEur J Cancer20097S2:abstr 7124.
  • WiederkehrDHoweCJCascianoRMotzerRZhengJBaladiJFOverall survival among metastatic renal cell carcinoma patients corrected for crossover using inverse probability of censoring weights: analysis from the RECORD-1 phase 3 trialEur J Cancer20097S2: abstr 7131.
  • KorhonenPHaasTZuberEKayALebwohlDMotzerROverall survival among metastatic renal cell carcinoma patients corrected for crossover using a rank preserving structural failure time model: analysis from the everolimus phase 3 trialEur J Cancer20097S2: abstr 7155.
  • Common terminology criteria for adverse events v3.0. Cancer Therapy Evaluation Program, US National Cancer Institute. 2006http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_30 Accessed Nov 30, 2009.
  • ChhajedPNDickenmannMBubendorfLMayrMSteigerJTammMPatterns of pulmonary complications associated with sirolimusRespiration20067336737416127266
  • PabloMHudesGDutcherJRadiographic findings of drug-induced pneumonitis and clinical correlation in patients with advanced renal cell carcinoma treated with temsirolimusEur J Cancer20097S2:abstr 7113.
  • AlbigesLCaramellaCFerteCInterstitial pneumonitis during RAD001 treatment: incidence by blinded radiological analysisEur J Cancer20097S2:abstr 7114.
  • MotzerRJEscudierBOudardSRAD001 vs placebo in patients with metastatic renal cell carcinoma after progression on VEGFr-TKI therapy: results from a randomized, double-blind, multicenter phase-III studyJ Clin Oncol200826suppl:abstr LBA5026.
  • GrunwaldVRhaSYMillerKAn international expanded access program of RAD001(everolimus) in patients with metastatic renal cell carcinoma who fail or become intolerant of a prior vascular endothelial growth factor therapyEur J Cancer20097S2:abstr 7154.
  • Expanded access study of RAD001 in metastatic renal cell cancer patients who are intolerant of or who have failed despite prior vascular endothelial growth factor therapy. NCT00655252. www.clinicaltrials.gov/ct2/results?term=NCT00655252 Accessed Nov 30, 2009.
  • HutsonTEDavisIDMachielsJ-PHEfficacy and safety of pazopanib in patients with metastatic renal cell carcinomaJ Clin Oncol20102847548020008644
  • RiniBIWildingGHudesGPhase II study of axitinib in sorafenib-refractory metastatic renal cell carcinomaJ Clin Oncol2009274462446819652060
  • HutsonTEFiglinRAKuhnJGMotzerRJTargeted therapies for metastatic renal cell carcinoma: an overview of toxicity and dosing strategiesOncologist2008131084109618838439
  • BellmuntJSzczylikCFeingoldJStrahsABerkenblitATemsirolimus safety profile and management of toxic effects in patients with advanced renal cell carcinoma and poor prognostic featuresAnn Oncol2008191387139218385198
  • SerugaBGanHKKnoxJJManaging toxicities and optimal dosing of targeted drugs in advanced kidney cancerCurr Oncol200916S1S52S5919478903
  • AtkinsMBHidalgoMStadlerWMRandomized 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 carcinomaJ Clin Oncol20042290991814990647
  • PendergrassKBHudesGRadulovicSCharacterization of hyperglycemia, hypercholesterolemia and hyperlipidemia in patients with advanced renal cell carcinoma treated with temsirolimus or interferon-αASCO Genitourinary Cancers Symposium 2009; abstr 297. Abstract and slides available from http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_meeting_categories_view&confID=64 Accessed Nov 30, 2009.
  • DutcherJPde SouzaPMcDermottDFiglinRAEffect of temsirolimus versus interferon-α on outcome of patients with advanced renal cell carcinoma of different tumor histologiesMed Oncol20092620220919229667
  • CaglioSSundlovASlimaneKMayCEscudierBOpen-label phase II trial of everolimus monotherapy for patients with advanced papillary renal cell cancer (RAPTOR): rationale and designEu J Cancer20097S2:abstr 7156.
  • RAPTOR: RAD001 as monotherapy in the treatment of advanced papillary renal cell tumors program in Europe (RAPTOR/LFR08). NCT00688753. Available from http://www.clinicaltrials.gov/ct2/results?term=NCT00688753 Accessed Nov 30, 2009.
  • RAD001 (everolimus) for advanced renal cell carcinoma before kidney removal. NCT00831480. http://www.clinicaltrials.gov/ct2/results?term=NCT00831480 Accessed Nov 30, 2009.
  • PantuckAJSeligsonDBKlatteTPrognostic relevance of the mTOR pathway in renal cell carcinomaCancer20071092257226717440983
  • ChoDSignorettiDDaboraSPotential histologic and molecular predictors of response to temsirolimus in patients with advanced renal cell carcinomaClin Genitourin Cancer2007537938517956710
  • FiglinRAde SouzaPMcDermottDAnalysis of PTEN and HIF-1α and correlation with efficacy in patients with advanced renal cell carcinoma treated with temsirolimus versus interferon-αCancer20091153651366019526589
  • Biomarker trial of everolimus in patients with advanced renal cell carcinoma. NCT00827359. http://www.clinicaltrials.gov/ct2/results?term=NCT00827359 Accessed Nov 30, 2009.
  • NogovaLZanderTGrossSHPharmacodynamics of RAD001 measured by early FDG PET in patients with recurrent NSCLCJ Clin Oncol200826suppl:abstr 14616.
  • SosmanJPuzanovICombination targeted therapy in advanced renal cell carcinomaCancer200911510 suppl2368237519402058
  • RyanCWVukyJChanJSBeerTMRothkopfMPhase II study of everolimus with imatinib in patients with previously-treated renal carcinomaJ Clin Oncol200927suppl:abstr e16075.
  • KroogGSFeldmanDRKondaguntaGVPhase I trial of RAD001 (everolimus) plus sunitinib in patients with metastatic renal cell carcinomaJ Clin Oncol200927suppl:abstr 5037.
  • HarzstarkALRosenbergJEWeinbergVKA phase I study of sorafenib and RAD001 for metastatic clear cell renal cell carcinomaJ Clin Oncol200927suppl:abstr 5104.
  • ZafarYBendellJLagerJPreliminary results of a phase I study of bevacizumab in combination with everolimus in patients with advanced solid tumorsJ Clin Oncol200624suppl:abstr 3097.
  • WhorfRCHainsworthJDSpigelDRPhase II study of bevacizumab and everolimus (RAD001) in the treatment of advanced renal cell carcinomaJ Clin Oncol200826suppl:abstr 5010. Abstract and associated presentation by JD Hainsworth available from http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_meeting_categories_view&confID=55 Accessed Nov 30, 2009.
  • Safety and efficacy of bevacizumab plus RAD001 versus interferon alfa-2a and bevacizumab in adult patients with kidney cancer (L2201). NCT00719264. http://www.clinicaltrials.gov/ct2/results?term=NCT00719264 Accessed Nov 30, 2009.
  • Efficacy and safety comparison of RAD001 versus sunitinib in the first-line and second-line treatment of patients with metastatic renal cell carcinoma (RECORD3). NCT00903175. http://www.clinicaltrials.gov/ct2/results?term=NCT00903175 Accessed Nov 30, 2009.
  • SoulieresDReview of guidelines on the treatment of metastatic renal cell carcinomaCurr Oncol200916S1S67S7019478902
  • Kidney cancer treatment for advanced disease, predominant clear cell histology, subsequent therapy after tyrosine kinase inhibitor therapy. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Kidney Cancer. V.2.2010http://www.nccn.org/professionals/physician_gls/f_guidelines.asp Accessed Nov 30, 2009.
  • EscudierBKatajaVRenal cell carcinoma: ESMO clinical recommendations for diagnosis, treatment and follow-upAnn Oncol200920S4iv81iv82
  • Canadian Kidney Cancer Forum 2009Management of kidney cancer: Canadian Kidney Cancer Forum consensus updateCan Urol Assoc J2009320020419543462