192
Views
28
CrossRef citations to date
0
Altmetric
Review

New developments in the treatment of metastatic melanoma – role of dabrafenib–trametinib combination therapy

&
Pages 77-88 | Published online: 24 Jun 2014

References

  • HowladerNNooneAMKrapchoMSurveillance, Epidemiology, and End Results Program (SEER) Cancer Statistics Review, 1975–2008 Available from: http://seer.cancer.gov/csr/1975_2008/Accessed May 17, 2014
  • GellerACMillerDRAnnasGDDemierreMFGilchrestBAKohHKMelanoma incidence and mortality among US whites, 1969–1999JAMA20022881719172012365954
  • VeierodMBWeiderpassEThornMA prospective study of pigmentation, sun exposure, and risk of cutaneous malignant melanoma in womenJ Natl Cancer Inst2003951530153814559875
  • RhodesARWeinstockMAFitzpatrickTBMihmMCJrSoberAJRisk factors for cutaneous melanoma. A practical method of recognizing predisposed individualsJAMA1987258314631543312689
  • XingYChangGJHuCYConditional survival estimates improve over time for patients with advanced melanoma: results from a population-based analysisCancer20101162234224120187100
  • BarthAWanekLAMortonDLPrognostic factors in 1,521 melanoma patients with distant metastasesJ Am Coll Surg19951811932017670677
  • BalchCMSoongSJGershenwaldJEPrognostic factors analysis of 17,600 melanoma patients: validation of the American Joint Committee on Cancer melanoma staging systemJ Clin Oncol2001193622333411504744
  • HodiFSO’DaySJMcDermottDFImproved survival with ipilimumab in patients with metastatic melanomaN Engl J Med201036371172320525992
  • RobertCThomasLBondarenkoIIpilimumab plus dacarbazine for previously untreated metastatic melanomaN Engl J Med20113642517252621639810
  • WeberJThompsonJAHamidOA randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanomaClin Cancer Res2009155591559819671877
  • WolchokJDNeynsBLinetteGIpilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging studyLancet Oncol20101115516420004617
  • O’DaySJMaioMChiarion-SileniVEfficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II studyAnn Oncol2010211712171720147741
  • TopalianSLSznolMMcDermottDFSurvival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumabJ Clin Oncol2014321020103024590637
  • ChapmanPBHauschildARobertCImproved survival with vemurafenib in melanoma with BRAF V600E mutationN Engl J Med20113642507251621639808
  • McArthurGAChapmanPBRobertCSafety and efficacy of vemurafenib in BRAF(V600E) and BRAF(V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label studyLancet Oncol20141532333224508103
  • SeetharamuNTuTJChristosPEnrollment in clinical trials correlates with improved survival in metastatic melanomaOncology20128140340922270052
  • FlahertyKTInfanteJRDaudACombined BRAF and MEK inhibition in melanoma with BRAF V600 mutationsN Engl J Med20123671694170323020132
  • DaviesHBignellGRCoxCMutations of the BRAF gene in human cancerNature200241794995412068308
  • CurtinJAFridlyandJKageshitaTDistinct sets of genetic alterations in melanomaN Engl J Med20053532135214716291983
  • PaikPKArcilaMEFaraMClinical characteristics of patients with lung adenocarcinomas harboring BRAF mutationsJ Clin Oncol2011292046205121483012
  • SantarpiaLQiYStemke-HaleKMutation profiling identifies numerous rare drug targets and distinct mutation patterns in different clinical subtypes of breast cancersBreast Cancer Res Treat201213433334322538770
  • SingerGOldtR3rdCohenYMutations in BRAF and KRAS characterize the development of low-grade ovarian serous carcinomaJ Natl Cancer Inst20039548448612644542
  • SingerGKurmanRJChangHWChoSKShihIeMDiverse tumorigenic pathways in ovarian serous carcinomaAm J Pathol20021601223122811943707
  • SiebenNLMacropoulosPRoemenGMIn ovarian neoplasms, BRAF, but not KRAS, mutations are restricted to low-grade serous tumoursJ Pathol200420233634014991899
  • KimuraETNikiforovaMNZhuZKnaufJANikiforovYEFaginJAHigh prevalence of BRAF mutations in thyroid cancer: genetic evidence for constitutive activation of the RET/PTC-RAS-BRAF signaling pathway in papillary thyroid carcinomaCancer Res2003631454145712670889
  • LupiCGianniniRUgoliniCAssociation of BRAF V600E mutation with poor clinicopathological outcomes in 500 consecutive cases of papillary thyroid carcinomaJ Clin Endocrinol Metab2007924085409017785355
  • CaroniaLMPhayJEShahMHRole of BRAF in thyroid oncogenesisClin Cancer Res2011177511751721900390
  • HutchinsGSouthwardKHandleyKValue of mismatch repair, KRAS, and BRAF mutations in predicting recurrence and benefits from chemotherapy in colorectal cancerJ Clin Oncol2011291261127021383284
  • ShinozakiMFujimotoAMortonDLHoonDSIncidence of BRAF oncogene mutation and clinical relevance for primary cutaneous melanomasClin Cancer Res2004101753175715014028
  • MaldonadoJLFridlyandJPatelHDeterminants of BRAF mutations in primary melanomasJ Natl Cancer Inst2003951878189014679157
  • LongGVMenziesAMNagrialAMPrognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanomaJ Clin Oncol2011291239124621343559
  • LukeJJHodiFSVemurafenib and BRAF inhibition: a new class of treatment for metastatic melanomaClin Cancer Res20121891422083257
  • LukeJJHodiFSIpilimumab, vemurafenib, dabrafenib, and trametinib: synergistic competitors in the clinical management of BRAF mutant malignant melanomaOncologist20131871712523709751
  • NazarianRShiHWangQMelanomas acquire resistance to B-RAF(V600E) inhibition by RTK or N-RAS upregulationNature201046897397721107323
  • JohannessenCMBoehmJSKimSYCOT drives resistance to RAF inhibition through MAP kinase pathway reactivationNature201046896897221107320
  • WagleNEmeryCBergerMFDissecting therapeutic resistance to RAF inhibition in melanoma by tumor genomic profilingJ Clin Oncol2011293085309621383288
  • PoulikakosPIPersaudYJanakiramanMRAF inhibitor resistance is mediated by dimerization of aberrantly spliced BRAF(V600E)Nature201148038739022113612
  • ShiHMoriceauGKongXMelanoma whole-exome sequencing identifies (V600E)B-RAF amplification-mediated acquired B-RAF inhibitor resistanceNat Commun2012372422395615
  • StraussmanRMorikawaTSheeKTumour micro-environment elicits innate resistance to RAF inhibitors through HGF secretionNature201248750050422763439
  • ShiHHongAKongXA novel AKT1 mutant amplifies an adaptive melanoma response to BRAF inhibitionCancer Discov20144697924265152
  • ShiHHugoWKongXAcquired resistance and clonal evolution in melanoma during BRAF inhibitor therapyCancer Discov20144809324265155
  • Van AllenEMWagleNSuckerAThe genetic landscape of clinical resistance to RAF inhibition in metastatic melanomaCancer Discov201449410924265153
  • KimKBFlahertyKTChapmanPBPattern and outcome of disease progression in phase I study of vemurafenib in patients with metastatic melanoma (MM)J Clin Oncol201129 Suppl8519
  • AckermanAKleinOMcDermottDFOutcomes of patients with metastatic melanoma treated with immunotherapy prior to or after BRAF inhibitorsCancer2272014 [Epub ahead of print.]
  • KatayamaRKhanTMBenesCTherapeutic strategies to overcome crizotinib resistance in non-small cell lung cancers harboring the fusion oncogene EML4-ALKProc Natl Acad Sci U S A20111087535734021502504
  • ChaftJEOxnardGRSimaCSKrisMGMillerVARielyGJDisease flare after tyrosine kinase inhibitor discontinuation in patients with EGFR-mutant lung cancer and acquired resistance to erlotinib or gefitinib: implications for clinical trial designClin Cancer Res2011176298630321856766
  • Le CesneARay-CoquardIBuiBNDiscontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trialLancet Oncol20101194294920864406
  • JosephEWPratilasCAPoulikakosPIThe RAF inhibitor PLX4032 inhibits ERK signaling and tumor cell proliferation in a V600E BRAF-selective mannerProc Natl Acad Sci U S A2010107149031490820668238
  • PoulikakosPIZhangCBollagGShokatKMRosenNRAF inhibitors transactivate RAF dimers and ERK signalling in cells with wild-type BRAFNature201046442743020179705
  • HatzivassiliouGSongKYenIRAF inhibitors prime wild-type RAF to activate the MAPK pathway and enhance growthNature201046443143520130576
  • HeidornSJMilagreCWhittakerSKinase-dead BRAF and oncogenic RAS cooperate to drive tumor progression through CRAFCell201014020922120141835
  • OberholzerPAKeeDDziunyczPRAS mutations are associated with the development of cutaneous squamous cell tumors in patients treated with RAF inhibitorsJ Clin Oncol20123031632122067401
  • GregerJEastmanSZhangVCombinations of BRAF, MEK, and PI3K/mTOR inhibitors overcome acquired resistance to the BRAF inhibitor GSK2118436 dabrafenib, mediated by NRAS or MEK mutationsMol Cancer Ther20121190992022389471
  • SuFVirosAMilagreCRAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitorsN Engl J Med201236620721522256804
  • InfanteJRFalchookGSLawrenceDPPhase I/II study to assess safety, pharmacokinetics, and efficacy of the oral MEK 1/2 inhibitor GSK1120212 (GSK212) dosed in combination with the oral BRAF inhibitor GSK2118436 (GSK436)J Clin Oncol201129SupplCRA8503
  • WagleNVan AllenEMTreacyDJMAP kinase pathway alterations in BRAF-mutant melanoma patients with acquired resistance to combined RAF/MEK inhibitionCancer Discov20144616824265154
  • Tafinlar [full prescribing information] Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdfAccessed May 17, 2014
  • Mekinist [full prescribing information] Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114s000lbl.pdfAccessed May 17, 2014
  • InfanteJRFecherLAFalchookGSSafety, pharmacokinetic, pharmacodynamic, and efficacy data for the oral MEK inhibitor trametinib: a phase 1 dose-escalation trialLancet Oncol20121377378122805291
  • YamaguchiTKakefudaRTajimaNSowaYSakaiTAntitumor activities of JTP-74057 (GSK1120212), a novel MEK1/2 inhibitor, on colorectal cancer cell lines in vitro and in vivoInt J Oncol201139233121523318
  • FalchookGSLongGVKurzrockRDabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trialLancet20123791893190122608338
  • LongGVTrefzerUDaviesMADabrafenib in patients with Val600Glu or Val600Lys BRAF-mutant melanoma metastatic to the brain (BREAK-MB): a multicentre, open-label, phase 2 trialLancet Oncol2012131087109523051966
  • HauschildAGrobJJDemidovLVDabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trialLancet201238035836522735384
  • HauschildAGrobJDemidovLAn update on BREAK-3, a phase III, randomized trial: Dabrafenib (DAB) versus dacarbazine (DTIC) in patients with BRAF V600E-positive mutation metastatic melanoma (MM)J Clin Oncol2013Suppl 319013
  • FalchookGSLewisKDInfanteJRActivity of the oral MEK inhibitor trametinib in patients with advanced melanoma: a phase 1 dose-escalation trialLancet Oncol20121378278922805292
  • KimKBKeffordRPavlickACPhase II study of the MEK1/MEK2 inhibitor Trametinib in patients with metastatic BRAF-mutant cutaneous melanoma previously treated with or without a BRAF inhibitorJ Clin Oncol20133148248923248257
  • FlahertyKTRobertCHerseyPImproved survival with MEK inhibition in BRAF-mutated melanomaN Engl J Med201236710711422663011
  • GoldingerSMZimmerLSchulzCUpstream mitogen-activated protein kinase (MAPK) pathway inhibition: MEK inhibitor followed by a BRAF inhibitor in advanced melanoma patientsEur J Cancer20145040641024183461
  • GlaxoSmithKlineGSK announces headline results for Phase III study of the combination of Tafinlar® (dabrafenib) and Mekinist®(trametinib) in metastatic melanoma Available from: http://us.gsk.com/html/media-news/pressreleases/2014/gsk-announces-headline-results-for-phase-iii-study-of-the-combin.htmlAccessed May 17, 2014
  • BealeSDicksonRBagustAVemurafenib for the treatment of locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma: a NICE single technology appraisalPharmacoeconomics2013311121112924114739
  • DaudAAshworthMKeffordRFPyrexia in patients treated with dabrafenib and trametinib for BRAFV600 mutation-positive metastatic melanomaPigment Cell Melanoma Res201326945
  • HamidORobertCDaudASafety and tumor responses with lambrolizumab (anti-PD-1) in melanomaN Engl J Med201336913414423724846
  • TopalianSLHodiFSBrahmerJRSafety, activity, and immune correlates of anti-PD-1 antibody in cancerN Engl J Med20123662443245422658127
  • WolchokJDKlugerHCallahanMKNivolumab plus ipilimumab in advanced melanomaN Engl J Med201336912213323724867
  • OttPAHodiFSRobertCCTLA-4 and PD-1/PD-L1 blockade: new immunotherapeutic modalities with durable clinical benefit in melanoma patientsClin Cancer Res2013195300530924089443
  • BoniACogdillAPDangPSelective BRAFV600E inhibition enhances T-cell recognition of melanoma without affecting lymphocyte functionCancer Res2010705213521920551059
  • RibasAHodiFSCallahanMKontoCWolchokJHepatotoxicity with combination of vemurafenib and ipilimumabN Engl J Med20133681365134623550685
  • OttPAHenryTBarandaSJInhibition of both BRAF and MEK in BRAF(V600E) mutant melanoma restores compromised dendritic cell (DC) function while having differential direct effects on DC propertiesCancer Immunol Immunother20136281182223306863
  • LukeJJOttPAKinase inhibitors and immune check-point blockade for the treatment of metastatic melanoma and advanced cancer: synergistic or antagonistic?Expert Opin Pharmacother2013142457246224138302