oncology grand rounds series - research to practice...ansell s et al. nivolumab in patients (pts)...

$: Oncology Grand Rounds Series - Research To Practice...Ansell S et al. Nivolumab in patients (pts) with relapsed or refractory classical Hodgkin lymphoma (R/R cHL): Clinical outcomes$
ResearchToPractice.com/ONSImmunotherapy2016 1

TARGET AUDIENCEThisactivityhasbeendesignedtomeettheeducationalneedsofoncologynurses,nursepractitionersandclinicalnursespecialistsinvolvedinthetreatmentofcancer.

OVERVIEW OF ACTIVITYThepastseveralyearshaveseenanexplosionintheemergenceofnewpotentialtherapiesthatleveragethenaturalabilityofthehumanbodytoattackandtreatcancer.Knownasimmune-mediatedtherapies,orcancerimmunother-apies,thesepromisingtreatmentsaretakingcenterstageatmedicalconferencesandgeneratingexcitementallovertheworld.Ofinterest,“immunotherapies”arenotnew,asscien-tistshavebeeninvestigatingstrategiestoelicitaneffectiveimmuneresponseagainstmalignanttumorsformorethanacenturyandthefirstimmunetreatmentsinoncologyreceivedFDAapprovalinthe1990s.Thenewestandperhapsmostexcitingarenaincancerimmunotherapyhasbeenthedevel-opmentandassessmentofimmune-modulatingantibodies,orcheckpointimmunemodulators.Todatestudieshavedemon-stratedthattheseagentsarehighlyactiveacrossanumberofdiseases,mostnotablymelanoma,renalcellcarcinoma,non-smallcelllungcancerandbladdercancer,representingthedawnofanewerainoncologictreatmentthatmayeffec-tivelytransformchemotherapyinfusionroomsintoimmuno-therapydeliverycenters.

Theintroductionofthesetherapieshascreatedamultitudeofuncertainties,importantclinicalquestionsandknowledgegapsawaitingresolution.Thisseemstobeparticularlytrueamongoncologynurses,whoplayanintegralroleinthesuccessfuldeliveryofsystemicanticancertherapyandthepreservationofpatientphysicalandpsychosocialwell-being,therebyrequiringthattheypossessavariedsetofskillsandanextensiveknowledgebase.Thesevideoproceedingsfromthefirstpartofan8-partintegratedCNEcurriculumorigi-nallyheldatthe2016ONSAnnualCongressfeaturediscus-sionswithleadingoncologyinvestigatorsandtheirnursingcounterpartsregardingactualpatientcasesandrecentclinicalresearchfindingsaffectingtheoptimaltherapeuticandsupportivecareforeachpatientscenario.

PURPOSE STATEMENTByprovidinginformationonthelatestresearchdevelopmentsinthecontextofexpertperspectives,thisCNEactivitywillassistoncologynurses,nursepractitionersandclinicalnursespecialistswiththeformulationofanunderstandingofthemechanismofactionofcancerimmunotherapies,theirroleintheclinicalalgorithmandtheuniquespectrumofassociatedsideeffectstofacilitateoptimalcareofpatientswithcancer.

LEARNING OBJECTIVES• Developabasicunderstandingofthehumanimmune

response,andidentifytheunderlyingmechanismsbywhichvariouscancersevadethisprocesstoproliferateandgrow.

• RecognizetheFDAapprovalsofnivolumab,pembrolizumabandthecombinationofnivolumabandipilimumabforthemanagementofmetastaticmelanoma,andunderstandwheretheseapproachesfitintotheclinicalalgorithm.

• Discussthemechanismofaction,clinicalefficacyandtolerabilityprofilesofcheckpointinhibitorsandotherimmunotherapiesinavarietyofcancers.

• Understandthebroadspectrumofuniquesideeffectsrelatedtoimmunotherapies,anddevelopaplantomonitorandcareforpatientsaccordingly.

• Recallthedesignofongoingclinicaltrialsevaluatingnovelimmunotherapeuticapproaches,andcounselappropriatelyselectedpatientsaboutavailabilityandparticipation.

ACCREDITATION STATEMENTResearchToPracticeisaccreditedasaproviderofcontinuingnursingeducationbytheAmericanNursesCredentialingCenter’sCommissiononAccreditation.

CREDIT DESIGNATION STATEMENTS Thiseducationalactivityfor2.2contacthoursisprovidedbyResearchToPracticeduringtheperiodofAugust2016throughAugust2017.

Thisactivityisawarded2.2ANCCpharmacotherapeuticcontacthours.

CNE Information

Oncology Grand Rounds Series:Part 1 — Cancer Immunotherapy


ONCC/ILNA CERTIFICATION INFORMATIONTheprogramcontenthasbeenreviewedbytheOncologyNursingCertificationCorporation(ONCC)andisacceptableforrecertificationpoints.ToreviewcertificationqualificationspleasevisitResearchToPractice.com/ONS2016/ILNA.

ONCCreviewisonlyfordesignatingcontenttobeusedforrecertificationpointsandisnotforCNEaccreditation.CNEprogramsmustbeformallyapprovedforcontacthoursbyanacceptableaccreditor/approverofnursingCEtobeusedforrecertificationbyONCC.IftheCNEproviderfailstoobtainformalapprovaltoawardcontacthoursbyanacceptableaccrediting/approvalbody,noinformationrelatedtoONCCrecertificationmaybeusedinrelationtotheprogram.

FOR SUCCESSFUL COMPLETIONThisisavideoCNEprogram.Toreceivecredit,partici-pantsshouldreadthelearningobjectivesandfacultydisclo-sures,watchthevideo,completethePost-testwithascoreof75%orbetterandfillouttheEducationalAssessmentandCreditFormlocatedatResearchToPractice.com/ONSImmuno-therapy2016/CNE.

CONTENT VALIDATION AND DISCLOSURESResearchToPractice(RTP)iscommittedtoprovidingitsparticipantswithhigh-quality,unbiasedandstate-of-the-arteducation.Weassessconflictsofinterestwithfaculty,plannersandmanagersofCNEactivities.Conflictsofinterestareidentifiedandresolvedthroughaconflictofinterestresolutionprocess.Inaddition,allactivitycontentisreviewedbybothamemberoftheRTPscientificstaffandanexternal,independentreviewerforfairbalance,scientificobjectivityofstudiesreferencedandpatientcarerecommendations.

FACULTY—Thefollowingfaculty(andtheirspouses/partners)reportedrelevantconflictsofinterest,whichhavebeenresolvedthroughaconflictofinterestresolutionprocess:

Marianne J Davies, DNP, ACNP-BC, AOCNP-BC AssistantProfessorOncologyNursePractitionerYaleCancerCenterNewHaven,Connecticut

Speakers Bureau: Bristol-MyersSquibbCompany,GenentechBioOncology,Merck.

Roy S Herbst, MD, PhD EnsignProfessorofMedicine(Oncology)ProfessorofPharmacologyChiefofMedicalOncologyDirector,ThoracicOncologyResearchProgramAssociateDirectorforTranslationalResearchYaleComprehensiveCancerCenterYaleSchoolofMedicineNewHaven,Connecticut

Advisory Committee:AstraZenecaPharmaceuticalsLP,BiotheraPharmaceuticals,Bristol-MyersSquibbCompany,Diatech,GenentechBioOncology,KolltanPharmaceuticalsInc,Lilly,Notl-microarrays;Consulting Agreements: Merck,PfizerInc.

Evan J Lipson, MD AssistantProfessor,MedicalOncologyMelanomaandCancerImmunologyProgramsJohnsHopkinsUniversitySchoolofMedicineTheSidneyKimmelComprehensiveCancerCenterBaltimore,Maryland

Advisory Committee: AmgenInc,CastleBiosciencesIncorpo-rated;Consulting Agreements: Bristol-MyersSquibbCompany,Merck.

Virginia J Seery, MSN, RN, ANP-BC NursePractitioner,CutaneousOncologyandBiologicsProgramBethIsraelDeaconessMedicalCenterBoston,Massachusetts

Norelevantconflictsofinteresttodisclose.

MODERATOR—Dr LoveispresidentandCEOofResearchToPractice,whichreceivesfundsintheformofeducationalgrantstodevelopCME/CNEactivitiesfromthefollowingcommercialinterests:AbbVieInc,AcertaPharma,AgendiaInc,AmgenInc,ArrayBioPharmaInc,AstellasPharmaGlobalDevelopmentInc,AstraZenecaPharmaceuticalsLP,BaxaltaInc,BayerHealthCarePharmaceuticals,BiodesixInc,bioTheranosticsInc,BoehringerIngelheimPharmaceu-ticalsInc,BostonBiomedicalPharmaInc,Bristol-MyersSquibbCompany,CelgeneCorporation,ClovisOncology,CTIBioPharmaCorp,DaiichiSankyoInc,DendreonPharma-ceuticalsInc,EisaiInc,ExelixisInc,FoundationMedicine,GenentechBioOncology,GenomicHealthInc,GileadSciencesInc,ImmunoGenInc,IncyteCorporation,JanssenBiotechInc,JazzPharmaceuticalsInc,Lilly,MedivationInc,Merck,MerrimackPharmaceuticalsInc,MyriadGeneticLaboratoriesInc,NanoStringTechnologies,NateraInc,NovartisPharma-ceuticalsCorporation,Novocure,OnyxPharmaceuticals,anAmgensubsidiary,PharmacyclicsLLC,anAbbVieCompany,PrometheusLaboratoriesInc,RegeneronPharmaceuticals,Sanofi,SeattleGenetics,Sigma-TauPharmaceuticalsInc,SirtexMedicalLtd,SpectrumPharmaceuticalsInc,TaihoOncologyInc,TakedaOncology,TevaOncology,TokaiPharma-ceuticalsIncandVisionGateInc.

RESEARCH TO PRACTICE STAFF AND EXTERNAL REVIEWERS—ThescientificstaffandreviewersforResearchToPracticehavenorelevantconflictsofinteresttodisclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indica-tions. Please refer to the official prescribing information for each product for discussion of approved indications, contra-indications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.


ThisactivityissupportedbyeducationalgrantsfromAstraZenecaPharmaceuticalsLP,Bristol-MyersSquibbCompany,GenentechBioOncologyandMerck.

Hardware/Software Requirements:Ahigh-speedInternetconnectionAmonitorsetto1280x1024pixelsormoreInternetExplorer7orlater,Firefox3.0orlater,Chrome,Safari3.0orlaterAdobeFlashPlayer10.2plug-inorlaterAdobeAcrobatReader(Optional)Soundcardandspeakersforaudio

Last review date: August2016

Expiration date: August2017

ThereisnoimpliedorrealendorsementofanyproductbyRTPortheAmericanNursesCredentialingCenter.


AmosSMetal. Autoimmunity associated with immunotherapy of cancer. Blood2011;118(3):499-509.

AnsellSetal.Nivolumab in patients (pts) with relapsed or refractory classical Hodgkin lymphoma (R/R cHL): Clinical outcomes from extended follow-up of a phase 1 study (CA209-039). Proc ASH 2015;Abstract 583.

ArmandPetal.PD-1 blockade with pembrolizumab in patients with classical Hodgkin lymphoma after brentuximab vedotin failure: Safety, efficacy, and biomarker assessment. Proc ASH 2015;Abstract 584.

BatleviCLetal.Novel immunotherapies in lymphoid malignancies.Nat Rev Clin Oncol2016;13(1):25-40.

GoldbergSBetal.Activity and safety of pembrolizumab in patients with metastatic non-small cell lung cancer with untreated brain metastases. Proc ASCO2015;Abstract 8035.

JohnsonDBetal.Ipilimumab therapy in patients with advanced melanoma and preexisting autoimmune disorders.JAMAOncol2016;2(2):234-40.

KlugerHMetal.Safety and activity of pembrolizumab in melanoma patients with untreated brain metastases.Proc ASCO 2015;Abstract 9009.

LeDTetal.PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med2015;372(26):2509-20.

PetrylakDPetal.A phase Ia study of MPDL3280A (anti-PDL1): Updated response and survival data in urothelial bladder cancer (UBC). Proc ASCO2015;Abstract 4501.

PlimackERetal.Pembrolizumab (MK-3475) for advanced urothelial cancer: Updated results and biomarker analysis from KEYNOTE-012.Proc ASCO2015;Abstract 4502.

RothermundtCetal.Successful treatment with an anti-PD-1 antibody for progressing brain metastases in renal cell cancer. Ann Oncol 2016;27(3):544-5.

SpiraAIetal.Efficacy, safety and predictive biomarker results from a randomized phase II study comparing atezolizumab (MPDL3280A) versus docetaxel in 2L/3L NSCLC (POPLAR).Proc ASCO2015;Abstract 8010.

TopalianSLetal.Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med2012;366(26):2443-54.

VilladolidJ,AminA.Immune checkpoint inhibitors in clinical practice: Update on management of immune-related toxicities. Transl Lung Cancer Res2015;4(5):560-75.

Select Publications

ResearchToPractice.com/ONSGI2016 1

TARGET AUDIENCEThisactivityhasbeendesignedtomeettheeducationalneedsofoncologynurses,nursepractitionersandclinicalnursespecialistsinvolvedinthetreatmentofgastrointestinal(GI)cancers.

OVERVIEW OF ACTIVITYCancerofthecolonandrectumisthefourthmostfrequentlydiagnosedcancerandthesecondmostcommoncauseofdeathamongallneoplasmsintheUnitedStates,accountingforapproximately8%ofallcancerdeaths.Therecentrapidexpansionofnovelbiomarkers,multigenesignaturesandmolecular-targetedsystemicagentshassignificantlyrefinedtheclinicalalgorithmsuchthatindividualizedtherapeuticapproacheshavebecomethestandard,andoverthepasttwodecadesanumberofnewpathways,receptorsandmoleculartargetshavebeenidentifiedandlinkedtocolorectalcancer(CRC)growthandprogression.Thisenhancedunderstandingofthebiologyofthediseasehasledtotheinvestigationandapprovalofseveralnoveltherapeuticapproaches.

Giventheprevalentnatureofthedisease,extensiveresourcesareallocatedtoCRCresearchandeducation.Interestingly,however,althoughindividuallylessfrequentlyencountered,thecollectionof“non-CRC”GIcancersaccountformoreperannumdeathsthanthoseattributedtotumorsofthecolonandrectumcombined.Importantly,amongthiscollectionofdistincttumors,twoareasinparticular—gastricandpancreaticcancer—havewitnessedseveralrecentadvancesthathavealreadydrasticallyalteredcurrenttreatmentconsid-erationsandapproaches.

Althoughthesenewoptionshavebeenwelcomedbyall,theycreateachallengeforthosemembersoftheinterdisciplinarytreatmentteamwhoarerequiredtolearnabout,explainandappropriatelyintegratethemintostandardclinicalpractice,particularlyoncologynurses,whoplayanintegralroleinthesuccessfuldeliveryofsystemicanticancertherapyandthepreservationofpatientphysicalandpsychosocialwell-being.Thesevideoproceedingsfromthesecondpartofan8-partintegratedCNEcurriculumoriginallyheldatthe2016ONSAnnualCongressfeaturediscussionswithleadingGIinves-tigatorsandtheirnursingcounterpartsregardingactualpatientcasesandrecentclinicalresearchfindingsaffectingtheoptimaltherapeuticandsupportivecareforeachpatientscenario.

PURPOSE STATEMENTByprovidinginformationonthelatestresearchdevelopmentsinthecontextofexpertperspectives,thisCNEactivitywillassistoncologynurses,nursepractitionersandclinicalnursespecialistswiththeformulationofstate-of-the-artclinicalmanagementstrategiestofacilitateoptimalcareofpatientswithGIcancers.

LEARNING OBJECTIVES• Applyexistingandemergingresearchdatatothe

therapeuticandsupportivecareofpatientswithmetastaticCRC(mCRC),gastriccancerandpancreaticcancer.

• Describetheclinicalimpactofandtoxicitiesassociatedwiththeuseofbevacizumab,EGFRinhibitors,regorafenibandTAS-102formCRC.

• AppreciatetherecentFDAapprovalsoframucirumab,TAS-102andMM-398,anddevelopeffectivestrategiestointegratetheseagentsintothemanagementofGIcancers.

• Developanevidence-basedalgorithmforthepreventionandameliorationofsideeffectsassociatedwithchemother-apeuticandbiologicagentsusedinthemanagementofmCRC.

• Considerage,performancestatusandotherclinicalandlogisticalfactorsintheselectionofsystemictherapyforpatientswithlocallyadvancedormetastaticpancreaticcancer.




CNE Information

Oncology Grand Rounds Series:Part 2 — Gastrointestinal Cancers




FOR SUCCESSFUL COMPLETIONThisisavideoCNEprogram.Toreceivecredit,participantsshouldreadthelearningobjectivesandfacultydisclosures,watchthevideo,completethePost-testwithascoreof75%orbetterandfillouttheEducationalAssessmentandCreditFormlocatedatResearchToPractice.com/ONSGI2016/CNE.

CONTENT VALIDATION AND DISCLOSURESResearchToPractice(RTP)iscommittedtoprovidingitsparticipantswithhigh-quality,unbiasedandstate-of-the-arteducation.Weassessconflictsofinterestwithfaculty,plannersandmanagersofCNEactivities.Conflictsofinterestareidentifiedandresolvedthroughaconflictofinterestresolutionprocess.Inaddition,allactivitycontentisreviewedbybothamemberoftheRTPscientificstaffandanexternal,independentreviewerforfairbalance,scientificobjectivityofstudiesreferencedandpatientcarerecommendations.


Johanna C Bendell, MDDirector,GIOncologyResearchAssociateDirector,DrugDevelopmentUnitSarahCannonResearchInstituteNashville,Tennessee


Philip A Philip, MD, PhDProfessorofOncologyandMedicineDirectorofGIandNeuroendocrineTumorsVicePresidentofMedicalAffairsKarmanosCancerInstituteWayneStateUniversityDetroit,Michigan

Advisory Committee:bioTheranosticsInc,CarisLifeSciences,CelgeneCorporation,EMDSeronoInc,HalozymeTherapeu-tics,LexiconPharmaceuticalsInc,MerrimackPharmaceuticalsInc;Contracted Research: AcertaPharma,BayerHealthCarePharmaceuticals,CelgeneCorporation,IncyteCorporation,KaryopharmTherapeutics,Lilly,Merck,MomentaPharmaceu-

ticalsInc,NovartisPharmaceuticalsCorporation,RocheLabo-ratoriesInc,TaihoOncologyInc,XBiotech;Speakers Bureau: AmgenInc,CelgeneCorporation,GenentechBioOncology,NovartisPharmaceuticalsCorporation.

Robin Sommers, DNP, ANP-BC, AOCNPDana-FarberCancerInstituteBoston,Massachusetts


Amanda K Wagner, MS, ANP-BC, AOCNPArthurGJamesCancerHospitalandRichardJSoloveResearchInstituteTheOhioStateUniversityComprehensiveCancerCenterColumbus,Ohio


MODERATOR—Dr LoveispresidentandCEOofResearchToPractice,whichreceivesfundsintheformofeducationalgrantstodevelopCME/CNEactivitiesfromthefollowingcommercialinterests:AbbVieInc,AcertaPharma,AgendiaInc,AmgenInc,ArrayBioPharmaInc,AstellasPharmaGlobalDevelopmentInc,AstraZenecaPharmaceuticalsLP,BaxaltaInc,BayerHealthCarePharmaceuticals,BiodesixInc,bioTheranosticsInc,BoehringerIngelheimPharmaceu-ticalsInc,BostonBiomedicalPharmaInc,Bristol-MyersSquibbCompany,CelgeneCorporation,ClovisOncology,CTIBioPharmaCorp,DaiichiSankyoInc,DendreonPharma-ceuticalsInc,EisaiInc,ExelixisInc,FoundationMedicine,GenentechBioOncology,GenomicHealthInc,GileadSciencesInc,ImmunoGenInc,IncyteCorporation,JanssenBiotechInc,JazzPharmaceuticalsInc,Lilly,MedivationInc,Merck,MerrimackPharmaceuticalsInc,MyriadGeneticLaboratoriesInc,NanoStringTechnologies,NateraInc,NovartisPharma-ceuticalsCorporation,Novocure,OnyxPharmaceuticals,anAmgensubsidiary,PharmacyclicsLLC,anAbbVieCompany,PrometheusLaboratoriesInc,RegeneronPharmaceuticals,Sanofi,SeattleGenetics,Sigma-TauPharmaceuticalsInc,SirtexMedicalLtd,SpectrumPharmaceuticalsInc,TaihoOncologyInc,TakedaOncology,TevaOncology,TokaiPharma-ceuticalsIncandVisionGateInc.



ThisactivityissupportedbyeducationalgrantsfromBayerHealthCarePharmaceuticals,Lilly,MerrimackPharmaceuticalsIncandTaihoOncologyInc.


BangYJetal.Relationship between PD-L1 expression and clinical outcomes in patients with advanced gastric cancer treated with the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) in KEYNOTE-012. Proc ASCO2015;Abstract 4001.

BangYJetal.Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): A phase 3, open-label, randomised controlled trial. Lancet 2010;376(9742):687-97.

BolandCR,GoelA.Microsatellite instability in colorectal cancer.Gastroenterology 2010;138(6):2073-87.e3.

BresciaFJetal.Palliative care in pancreatic cancer.Cancer Control 2004;11(1):39-45.

ConroyTetal.FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.N Engl J Med 2011;364(19):1817-25.

DickenBJetal.Gastric adenocarcinoma: Review and considerations for future directions. Ann Surg2005;241(1):27-39.

FuchsCSetal.Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarci-noma (REGARD): An international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 2014;383(9911):31-9.

GrotheyAetal.Time course of regorafenib-associated adverse events in the phase III CORRECT study. GastrointestinalCancersSymposium2013;Abstract 467.

KawasakiKetal.Early tumor cavitation with regorafenib in metastatic colorectal cancer: A case report.Oncol Lett 2016;11(1):231-3.

KoAHetal.A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer.Br J Cancer2013;109(4):920-5.

LeDTetal. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med2015;372(26):2509-20.

MayerRJetal.Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med2015;372(20):1909-19.

RiallTSetal.Underutilization of surgical resection in patients with localized pancreatic cancer. Ann Surg2007;246(2):181-2.

RibasAetal.Tumor immunotherapy directed at PD-1. N Engl J Med2012;366(26):2517-9.

VonHoffDetal.NAPOLI-1: Randomized phase 3 study of MM-398 (nal-IRI), with or without 5-fluorouracil and leucovorin, versus 5-fluorouracil and leucovorin, in metastatic pancreatic cancer progressed on or following gemcitabine-based therapy. Ann Oncol2014;25(2):105-6.

VonHoffDDetal.Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 2013;369(18):1691-703.

WilkeHetal.Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): A double-blind, randomised phase 3 trial. Lancet Oncol 2014;15(11):1224-35.

YoshinoTetal.Results of a multicenter, randomized, double-blind, phase III study of TAS-102 vs placebo, with best supportive care (BSC), in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard therapies (RECOURSE). ESMO16thWorldCongressonGastrointestinalCancer2014;Abstract O-0022.

Select Publications

ResearchToPractice.com/ONSLung2016 1

TARGET AUDIENCEThisactivityhasbeendesignedtomeettheeducationalneedsofnursepractitionersandclinicalnursespecialistsinvolvedinthetreatmentofnon-smallcelllungcancer(NSCLC).

OVERVIEW OF ACTIVITYLungcancerisadevastatingdiseasewithbroad-reachingimpactonpublichealth,asitaccountsfor14%ofallnewcancercasesintheUnitedStatesandthemostcancer-relateddeathsamongbothmenandwomen.Thenumberofavailablecytotoxicchemotherapiesexhibitingactivityinlungcancerhasincreasedsubstantiallyoverthepastseveralyears,andconse-quently,clinicianknowledgeofthespecificrisk-benefitprofilesofthemanyacceptablesystemicregimensisoftheutmostimportanceinmakinginformedandindividualizedpatientcaredecisions.Developmentofnewtherapeuticstrategiesbeyondcytotoxicchemotherapyhasbeenthefocusofextensiveresearchandhasledtoanexplosioninlungcancergeneticandbiologicknowledge,resultingintheavailabilityofseveralmolecular-targetedtherapiesdemonstratingsomedegreeofactivityinsubsetsofNSCLCwithuniquetolerabilityprofilesthataredistinctfromthoseoftraditionalchemotherapeutics.Inadditiontothesignificantstridesmadeinunderstandingandtargetingspecificmutationsresponsibleforthepatho-genesisoflungcancer,recentinsightsintohowtoharnessthebody’sownimmunesystemarenowbeingappliedtothemanagementofthislethaldisease.

Theadventofthesetreatmentoptionspresentsnewpromiseofbothefficacyandenhancedsafetyforpatientsbutalsochallengespracticingoncologistsandtheirsupportstafftoappropriatelyselectindividualswhomaybenefitfromtheseagentsandtodeterminehowtointegratesuchtherapies,astheybecomeavailable,intostandardlungcancertreatmentalgorithms.Thisisparticularlytrueofoncologynurses,whoplayanintegralroleinthesuccessfuldeliveryofsystemicanticancertherapyandthepreservationofpatientphysicalandpsychosocialwell-being.Thesevideoproceedingsfromthethirdpartofan8-partintegratedCNEcurriculumorigi-nallyheldatthe2016ONSAnnualCongressfeaturediscus-sionswithleadingoncologyinvestigatorsandtheirnursingcounterpartsregardingactualpatientcasesandrecentclinicalresearchfindingsaffectingtheoptimaltherapeuticandsupportivecareforeachpatientscenario.

PURPOSE STATEMENTByprovidinginformationonthelatestresearchdevelopmentsinthecontextofexpertperspectives,thisCNEactivitywillassistoncologynurses,nursepractitionersandclinicalnursespecialistswiththeformulationofstate-of-the-artclinicalmanagementstrategiestofacilitateoptimalcareofpatientswithNSCLC.

LEARNING OBJECTIVES• Communicatetheclinicalrelevanceofgenemutationsand

tumorhistologytopatientswithNSCLC.

• Discussthebenefitsandrisksassociatedwithsystemictreatmentsusedintheevidence-basedmanagementofmetastaticNSCLC,includingchemotherapeuticagents,targetedbiologictherapiesandnovelimmunotherapies.

• Usebiomarkers,clinicalcharacteristicsandtumorhistologytoselectindividualizedfront-lineandsubsequenttreatmentapproachesforpatientswithmetastaticNSCLC.

• RecognizetherecentFDAapprovalsoframucirumab,nivolumabandpembrolizumabforpatientswithprogressivemetastaticNSCLC,anddiscernhowtheseagentscanbesafelyadministeredtoappropriatepatientswithsquamousandnonsquamousdisease.

• Educatepatientsaboutthepotentialsideeffectsassociatedwithcommonlyemployedtherapies,andprovidepreventiveandemergentstrategiestoreduceoramelioratethesetoxicities.





CNE Information

Oncology Grand Rounds Series:Part 3 — Non-Small Cell Lung Cancer



FOR SUCCESSFUL COMPLETIONThisisavideoCNEprogram.Toreceivecredit,participantsshouldreadthelearningobjectivesandfacultydisclosures,watchthevideo,completethePost-testwithascoreof75%orbetterandfillouttheEducationalAssessmentandCreditFormlocatedatResearchToPractice.com/ONSLung2016/CNE.

CONTENT VALIDATION AND DISCLOSURESResearchToPractice(RTP)iscommittedtoprovidingitsparticipantswithhigh-quality,unbiasedandstate-of-the-arteducation.Weassesspotentialconflictsofinterestwithfaculty,plannersandmanagersofCNEactivities.Conflictsofinterestareidentifiedandresolvedthroughaconflictofinterestresolutionprocess.Inaddition,allactivitycontentisreviewedbybothamemberoftheRTPscientificstaffandanexternal,independentreviewerforfairbalance,scientificobjectivityofstudiesreferencedandpatientcarerecommendations.


Sarah B Goldberg, MD, MPH AssistantProfessorofMedicineMedicalOncologyYaleCancerCenterNewHaven,Connecticut

Advisory Committee: ClovisOncology;Contracted Research: AstraZenecaPharmaceuticalsLP,BoehringerIngelheimPharmaceuticalsInc.

John V Heymach, MD, PhD ProfessorandChairThoracic/HeadandNeckMedicalOncologyTheUniversityofTexasMDAndersonCancerCenterHouston,Texas

Advisory Committee and Consulting Agreements: AstraZenecaPharmaceuticalsLP,BoehringerIngelheimPharmaceuticalsInc,ExelixisInc,GenentechBioOncology,GlaxoSmithKline,Lilly,NovartisPharmaceuticalsCorporation,SyntaPharmaceu-ticalsCorp;Contracted Research:AstraZenecaPharmaceuti-calsLP,BayerHealthCarePharmaceuticals,GlaxoSmithKline.

Amanda E Magnoli, MSN, RN, ANP-BC, AOCNPNewEnglandCancerSpecialistsScarborough,Maine


Wendi J Stone, MSN, RN, NP-C Thoracic/HeadandNeckMedicalOncologyTheUniversityofTexasMDAndersonCancerCenterHouston,Texas


MODERATOR—Dr Love ispresidentandCEOofResearchToPractice,whichreceivesfundsintheformofeducationalgrantstodevelopCME/CNEactivitiesfromthefollowingcommercialinterests:AbbVieInc,AcertaPharma,AgendiaInc,AmgenInc,ArrayBioPharmaInc,AstellasPharmaGlobalDevelopmentInc,AstraZenecaPharmaceuticalsLP,BaxaltaInc,BayerHealthCarePharmaceuticals,BiodesixInc,bioTheranosticsInc,BoehringerIngelheimPharmaceu-ticalsInc,BostonBiomedicalPharmaInc,Bristol-MyersSquibbCompany,CelgeneCorporation,ClovisOncology,CTIBioPharmaCorp,DaiichiSankyoInc,DendreonPharma-ceuticalsInc,EisaiInc,ExelixisInc,FoundationMedicine,GenentechBioOncology,GenomicHealthInc,GileadSciencesInc,ImmunoGenInc,IncyteCorporation,InfinityPharmaceu-ticalsInc,JanssenBiotechInc,JazzPharmaceuticalsInc,Lilly,MedivationInc,Merck,MerrimackPharmaceuticalsInc,MyriadGeneticLaboratoriesInc,NanoStringTechnologies,NateraInc,NovartisPharmaceuticalsCorporation,Novocure,OnyxPharmaceuticals,anAmgensubsidiary,Pharmacy-clicsLLC,anAbbVieCompany,PrometheusLaboratoriesInc,RegeneronPharmaceuticals,Sanofi,SeattleGenetics,Sigma-TauPharmaceuticalsInc,SirtexMedicalLtd,SpectrumPharmaceuticalsInc,TaihoOncologyInc,TakedaOncology,TevaOncology,TokaiPharmaceuticalsIncandVisionGateInc.


This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indica-tions. Please refer to the official prescribing information for each product for discussion of approved indications, contra-indications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors

ThisactivityissupportedbyeducationalgrantsfromAstellasPharmaGlobalDevelopmentInc,AstraZenecaPharmaceu-ticalsLP,CelgeneCorporation,GenentechBioOncology,MerckandNovartisPharmaceuticalsCorporation.






BergethonKetal.ROS1 rearrangements define a unique molecular class of lung cancers.J Clin Oncol 2012;30(8):863-70.

BorghaeiHetal.Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 2015;373(17):1627-39.

FukuokaMetal.Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol2011;29(21):2866-74.

GaronEBetal;KEYNOTE-001Investigators. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 2015;372(21):2018-28.

IchiharaEetal.Phase II trial of gefitinib in combination with bevacizumab as first-line therapy for advanced non-small cell lung cancer with activating EGFR gene mutations: The Okayama Lung Cancer Study Group trial 1001. J Thorac Oncol 2015;10(3):486-91.

JännePAetal.AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med2015;372(18):1689-99.

KimDWetal.Results of a global phase II study with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC). Proc ASCO2012;Abstract 7533.

KrisMGetal. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA 2014;311(19):1998-2006.

LynchTJJretal.Epidermal growth factor receptor inhibitor-associated cutaneous toxicities: An evolving paradigm in clinical management. Oncologist2007;12(5):610-21.

OuSHIetal.Efficacy and safety of the ALK inhibitor alectinib in ALK+ non-small-cell lung cancer (NSCLC) patients who have failed prior crizotinib: An open-label, single-arm, global phase 2 study (NP28673). Proc ASCO2015;Abstract 8008.

ParkKetal.Afatinib (A) vs gefitinib (G) as first-line treatment for patients (pts) with advanced non-small cell lung cancer (NSCLC) harboring activating EGFR mutations: Results of the global, randomized, open-label, phase IIb trial LUX-Lung 7 (LL7). Proc ESMO2015;Abstract LBA2_PR.

PlanchardDetal.Interim results of a phase II study of the BRAF inhibitor (BRAFi) dabrafenib (D) in combination with the MEK inhibitor trametinib (T) in patients (pts) with BRAF V600E mutated (mut) metastatic non-small cell lung cancer (NSCLC). Proc ASCO2015;Abstract 8006.

RicciardiSetal. Toxicity of targeted therapy in non-small-cell lung cancer management. Clin Lung Cancer 2009;10(1):28-35.

RizviNAetal.Safety and efficacy of first-line nivolumab (NIVO; anti-programmed death-1 [PD-1]) and ipilimumab in non-small cell lung cancer (NSCLC).Proc IASLC2015;Abstract ORAL02.05.

RosellRetal.Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): A multicentre, open-label, randomised phase 3 trial. Lancet Oncol 2012;13(3):239-46.

SequistLVetal.First-in-human evaluation of CO-1686, an irreversible, highly selective tyrosine kinase inhibitor of mutations of EGFR (activating and T790M).Proc ASCO2015;Abstract 8010.

SequistLVetal.Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013;31(27):3327-34.

SetoTetal.Erlotinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring EGFR mutations (JO25567): An open-label, randomised, multicentre, phase 2 study. Lancet Oncol 2014;15(11):1236-44.

ShawATetal.Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: A single-group, multicentre, phase 2 trial. Lancet Oncol 2016;17(2):234-42.

ShawATetal.Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med 2014;370(13):1189-97.

ShawATetal. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med2014;371(21):1963-71.

SocinskiMAetal.Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer. Ann Oncol 2013;24(9):2390-6.

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SocinskiMAetal.Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer. Ann Oncol 2013;24(2):314-21.

SocinskiMAetal.Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: Final results of a phase III trial. J Clin Oncol 2012;30(17):2055-62.

SodaMetal. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature2007;448(7153):561-6.

SpigelDRetal.Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Proc ASCO 2013;Abstract 8008.

TakeuchiKetal.RET, ROS1 and ALK fusions in lung cancer. Nat Med2012;18(3):378-81.

WuYLetal.Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): An open-label, randomised phase 3 trial. Lancet Oncol 2014;15(2):213-22.

YangJCetal.Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): Analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol2015;16(2):141-51.

YuHAetal.Poor response to erlotinib in patients with tumors containing baseline EGFR T790M mutations found by routine clinical molecular testing. Ann Oncol2014;25(2):423-8.

YuHAetal.Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers.Clin Cancer Res 2013;19(8):2240-7.

ZhouCetal.Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): A multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2011;12(8):735-42.

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ResearchToPractice.com/ONSBreast2016 1

TARGET AUDIENCEThisactivityhasbeendesignedtomeettheeducationalneedsofoncologynurses,nursepractitionersandclinicalnursespecialistsinvolvedinthetreatmentofbreastcancer(BC).

OVERVIEW OF ACTIVITYBCremainsthemostfrequentlydiagnosedcancerinwomen,andin2016intheUnitedStatesalonethediseasewillculminateinanestimated246,660newcasesand40,450deaths.Currentclinicalmanagementismultidisciplinaryandincludessurgicalresectionoflocaldiseasewithorwithoutradiationtherapyandthetreatmentofsystemicdiseasewithcytotoxicchemotherapy,endocrinetherapy,biologictherapyorcombinationsoftheseapproaches.AlthoughthediagnosisandtreatmentofBCremains,inmanyways,moreadvancedthaninothersolidtumors,challengingissuesinthebasicmanagementofthisdiseasecontinuetorequirerefinement.Increasingly,anemphasisisbeingplacedona“person-alizedmedicine”approachthatpromisestomoreeffectivelyidentifyspecifictreatmentsthatwillbenefitindividualsbasedonspecificpatient-anddisease-relatedcharacteristics.Thepaceofchangeinthefieldofbreastmedicaloncologyhasbeenrapid,anditisexpectedthataplethoraofnewdatawillcontinuouslybedisseminatedandwillrequireongoingeffortstokeepmedicalprofessionalsinformedabouttheuniquemechanismsofaction,toxicitiesandeffectivenessofnovelagents.

Althoughmedicaloncologistshavebeenroutinelyresponsibleforcounselingpatientswithregardtotherapeuticdecision-making,oncologynursesplayanintegralroleinthesuccessfuldeliveryofsystemicanticancertherapyandinthepreservationofpatientphysicalandpsychosocialwell-being.Thesevideoproceedingsfromthefourthpartofan8-partintegratedCNEcurriculumoriginallyheldatthe2016ONSAnnualCongressfeaturediscussionswithleadingBCinvestigatorsandtheirnursingcounterpartsregardingactualpatientcasesandrecentclinicalresearchfindingsaffectingtheoptimaltherapeuticandsupportivecareforeachpatientscenario.

PURPOSE STATEMENTByprovidinginformationonthelatestresearchdevelopmentsinthecontextofexpertperspectives,thisCNEactivitywillassistoncologynurses,nursepractitionersandclinicalnursespecialistswiththeformulationofstate-of-the-artclinicalmanagementstrategiestofacilitateoptimalcareofpatientswithBC.


diagnostic,therapeuticandsupportivecareofpatientswithearlyandadvancedBC.

• Describetheinfluenceoftumorphenotypesintailoringsystemictreatmentdecisions.

• Discussthebenefitsandrisksassociatedwithsystemictherapiesusedintheevidence-basedtreatmentofBC,includingendocrineagents,chemotherapyregimensandbiologictreatments.

• Developaplantomanagethesideeffectsassociatedwiththesetherapiestosupportqualityoflifeandcontinuationoftreatment.

• Assessemergingresearchonthesafetyandefficacyofnovelagentsunderdevelopmentinpreparationforthepotentialavailabilityofthesetherapies.

• IdentifyopportunitiestoenhancethecollaborativeroleofoncologynursesinthecomprehensivebiopsychosocialcareofpatientswithearlyandadvancedBC.




CNE Information

Oncology Grand Rounds Series:Part 4 — Breast Cancer




FOR SUCCESSFUL COMPLETIONThisisavideoCNEprogram.Toreceivecredit,participantsshouldreadthelearningobjectivesandfacultydisclosures,watchthevideo,completethePost-testwithascoreof75%orbetterandfillouttheEducationalAssessmentandCreditFormlocatedatResearchToPractice.com/ONSBreast2016/CNE.

CONTENT VALIDATION AND DISCLOSURESResearchToPractice(RTP)iscommittedtoprovidingitsparticipantswithhigh-quality,unbiasedandstate-of-the-arteducation.Weassesspotentialconflictsofinterestwithfaculty,plannersandmanagersofCNEactivities.Conflictsofinterestareidentifiedandresolvedthroughaconflictofinterestresolutionprocess.Inaddition,allactivitycontentisreviewedbybothamemberoftheRTPscientificstaffandanexternal,independentreviewerforfairbalance,scientificobjectivityofstudiesreferencedandpatientcarerecommen-dations.


Kimberly L Blackwell, MDProfessorofMedicineDirector,BreastCancerProgramDukeCancerInstituteDurham,NorthCarolina

Advisory Committee: AmgenInc,CelgeneCorporation,GenentechBioOncology,Lilly,NovartisPharmaceuticalsCorporation,PfizerInc,SpectrumPharmaceuticalsInc;Consulting Agreements:IncyteCorporation,RocheLabora-toriesInc,Sandoz; Contracted Research:CelgeneCorporation,GenentechBioOncology,NovartisPharmaceuticalsCorpo-ration,PfizerInc.

Emily Olson, APRN, CNP, MSNInstructorinOncologyMayoClinic,RochesterDivisionofMedicalOncologyRochester,Minnesota


Joyce O’Shaughnessy, MD Chair,BreastCancerResearchProgramBaylorCharlesASammonsCancerCenterTexasOncologyUSOncologyDallas,Texas

Consulting Agreements:AstraZenecaPharmaceuticalsLP,CelgeneCorporation,EisaiInc,GenentechBioOncology,Lilly,NovartisPharmaceuticalsCorporation,PfizerInc,RocheLaboratoriesInc,Sanofi,TakedaOncology.

Jennie Petruney, BSN, MSN, ANPNursePractitionerUniversityofNorthCarolinaBreastOncologyProgramChapelHill,NorthCarolina






ThisactivityissupportedbyeducationalgrantsfromAstraZenecaPharmaceuticalsLP,CelgeneCorporation,GenentechBioOncology,LillyandNovartisPharmaceuticalsCorporation.






BaselgaJetal.Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med2012;366(6):520-9.

BaselgaJetal.Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med2012;366(2):109-19.

DeSantisCEetal.Breast cancer statistics, 2015: Convergence of incidence rates between black and white women. CA Cancer J Clin2016;66(1):31-42.

DiCosimoS,BaselgaJ.Management of breast cancer with targeted agents: Importance of heterogeneity. Nat Rev Clin Oncol 2010;7(3):139-47.

GoetzMetal.MONARCH 3: A randomized phase III study of anastrozole or letrozole plus abemaciclib, a CDK4/6 inhibitor, or placebo in first-line treatment of women with HR+, HER2-locoregionally recurrent or metastatic breast cancer (MBC).Proc ASCO 2015;Abstract TPS624.

HarbeckNetal.HER2 dimerization inhibitor pertuzumab — Mode of action and clinical data in breast cancer. Breast Care (Basel)2013;8(1):49-55.

LoRussoPMetal.Trastuzumab emtansine: A unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positive cancer. Clin Cancer Res 2011;17(20):6437-47.

LoveNetal.HER2 and estrogen receptor status drive decisions regarding the use of neoadjuvant chemotherapy. SanAntonioBreastCancerSymposium2015;Abstract P1-14-20.

NandaRetal.A phase Ib study of pembrolizumab (MK-3475) in patients with advanced triple-negative breast cancer. SanAntonioBreastCancerSymposium2014;Abstract S1-09.

RowinskyEK.Signal events: Cell signal transduction and its inhibition in cancer. Oncologist2003;8(3):5-17.

SaphnerTetal.Annual hazard rates of recurrence for breast cancer after primary therapy.J Clin Oncol1996;14(10):2738-46.

SwainSMetal.Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 2015;372(8):724-34.

SwainSMetal.Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): Overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013;14(6):461-71.

SwainSMetal.Confirmatory overall survival (OS) analysis of CLEOPATRA: A randomized, double-blind, placebo-controlled Phase III study with pertuzumab (P), trastuzumab (T), and docetaxel (D) in patients (pts) with HER2-positive first-line (1L) metastatic breast cancer (MBC). SanAntonioBreastCancerSymposium2012;Abstract P5-18-26.

TolaneySetal.A phase Ib study of abemaciclib with therapies for metastatic breast cancer. Proc ASCO2015;Abstract 522.

TolaneySMetal.Clinical activity of abemaciclib, an oral cell cycle inhibitor, in metastatic breast cancer. SanAntonioBreastCancerSymposium2014;Abstract P5-19-13.

TrainaTAetal.Results from a phase 2 study of enzalutamide (ENZA), an androgen receptor (AR) inhibitor, in advanced AR+ triple-negative breast cancer (TNBC). Proc ASCO2015;Abstract 1003.

TurnerNCetal.Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med 2015;373(3):209-19.

TurnerNCetal.PALOMA3: A double-blind, phase III trial of fulvestrant with or without palbociclib in pre- and post-menopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on prior endocrine therapy. Proc ASCO2015;Abstract LBA502.

TuttNJetal.OlympiA: A randomized phase III trial of olaparib as adjuvant therapy in patients with high-risk HER2-negative breast cancer (BC) and a germline BRCA1/2 mutation (gBRCAm). Proc ASCO2015;Abstract TPS1109.

VermaSetal. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med2012;367(19):1783-91.

VogelCetal.Management of ErbB2-positive breast cancer: Insights from preclinical and clinical studies with lapatinib.Jpn J Clin Oncol 2010;40(11):999-1013.

YardenY,SliwkowskiMX.Untangling the ErbB signalling network. Nat Rev Mol Cell Biol 2001;2(2):127-37.

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ResearchToPractice.com/ONSOvarian2016 1

TARGET AUDIENCEThisactivityhasbeendesignedtomeettheeducationalneedsofoncologynurses,nursepractitionersandclinicalnursespecialistsinvolvedinthetreatmentofovariancancer(OC).

OVERVIEW OF ACTIVITYGynecologiccancerscomprise5primarycancersaffectingtheovaries,uterinecorpus(endometrialcancer),uterinecervix(cervicalcancer),vulvaandvagina.Ofthese,OChascontinuallybeenthemostlethal.TheAmericanCancerSocietyestimatesthatin2016,14,240individualswilldieofthisdisease,accountingfornearly50%ofdeathsattrib-utabletogynecologiccancers.Aswithmanyothertumors,patientoutcomesarecriticallydependentuponeffectivemultidisciplinarycare,whichoftenincludescontributionsfromgynecologic,medicalandradiationoncologistsaswellaspathologists,diagnosticradiologists,oncologynursesandpsychosocialservices.Inadditiontothedisease-andtreatment-relatedmorbidityandmortalityassociatedwithgynecologiccancers,pain,fatigue,lymphedema,depression/anxiety,infertility/childbearingandsexualdysfunctionarecommonlyoccurringissuesthatmustalsobeaddressedinthecareofthesepatients.

OncologynursesplayapivotalroleinsupportingpatientsthroughtheirtherapeuticjourneyandareessentialtothedeliveryofacompletecourseofeffectivesystemictreatmentforOC.Thesevideoproceedingsfromthefifthpartofan8-partintegratedCNEcurriculumoriginallyheldatthe2016ONSAnnualCongressfeaturediscussionswithleadingOCinvestigatorsandtheirnursingcounterpartsregardingactualpatientcasesandrecentclinicalresearchfindingsaffectingtheoptimaltherapeuticandsupportivecareforeachpatientscenario.

PURPOSE STATEMENTByprovidinginformationonthelatestresearchdevelopmentsinthecontextofexpertperspectives,thisCNEactivitywillassistoncologynurses,nursepractitionersandclinicalnursespecialistswiththeformulationofstate-of-the-artclinicalmanagementstrategiestofacilitateoptimalcareofpatientswithOC.


diagnostic,therapeuticandsupportivecareofpatientswithOC.

• Demonstrateknowledgeofexistingguidelinesandconsensusstatementsregardingtherationaleforgeneticcounseling/testingforallpatientswithnewlydiagnosedOC,regardlessoffamilyhistory.

• Developanunderstandingoftheinitialandlong-termtreatmentofadvancedOCconsideringtheroleoftherecentlyapprovedanti-VEGFantibodybevacizumab.

• Implementanevidence-basedapproachtothepreventionandameliorationofsideeffectsassociatedwithchemother-apeuticandbiologicagentsusedinthemanagementofOC.

• AppreciatetherecentFDAapprovalofolaparibforpatientswithhighlyrefractoryadvancedOC,andsafelyintegratethisagentintotheclinicalmanagementofappropriateindividuals.

• RecallongoingtrialsofinvestigationalapproachesandagentsinOC,andreferpatientsandobtainconsentforstudyparticipation.





ONCCreviewisonlyfordesignatingcontenttobeusedforrecertificationpointsandisnotforCNEaccreditation.CNEprogramsmustbeformallyapprovedforcontacthoursbyan

CNE Information

Oncology Grand Rounds Series:Part 5 — Ovarian Cancer


acceptableaccreditor/approverofnursingCEtobeusedforrecertificationbyONCC.IftheCNEproviderfailstoobtainformalapprovaltoawardcontacthoursbyanacceptableaccrediting/approvalbody,noinformationrelatedtoONCCrecertificationmaybeusedinrelationtotheprogram.

FOR SUCCESSFUL COMPLETIONThisisavideoCNEprogram.Toreceivecredit,participantsshouldreadthelearningobjectivesandfacultydisclosures,watchthevideo,completethePost-testwithascoreof75%orbetterandfillouttheEducationalAssessmentandCreditFormlocatedatResearchToPractice.com/ONSOvarian2016/CNE.



Paula J Anastasia, RN, MN, AOCNGyn-OncologyClinicalNurseSpecialistCedars-SinaiMedicalCenterLosAngeles,California

Speakers Bureau:GenentechBioOncology.

Lisa B Arvine, RN, MSN, ANP-BC, WHNP-BCDana-FarberCancerInstituteBoston,Massachusetts


Robert L Coleman, MDProfessorandDeputyChairmanViceChair,ClinicalResearchAnnRifeCoxChairinGynecologyDepartmentofGynecologicOncologyandReproductiveMedicineHouston,Texas

Advisory Committee: AbbottLaboratories,AbbVieInc,AmgenInc,AstraZenecaPharmaceuticalsLP,BayerHealthCarePharmaceuticals,CarisLifeSciences,CelgeneCorporation,CeruleanPharmaInc,ClovisOncology,CritiTechInc,EisaiInc,GenentechBioOncology,Genmab,GlaxoSmithKline,ImmunoGenInc,IncyteCorporation,JanssenBiotechInc,Merck,MerrimackPharmaceuticalsInc,Nektar,TakedaOncology,VentiRxPharmaceuticalsInc;Consulting Agreement: CelgeneCorporation;Contracted Research: ArrayBioPharmaInc,AstraZenecaPharmaceuticalsLP,Clovis

Oncology,EMDSeronoInc,JanssenBiotechInc,Merck,OncoMedPharmaceuticalsInc,TakedaOncology.

Kathleen Moore, MDJimandChristyEverestEndowedChairinCancerResearchDirector,OklahomaTSETPhaseIProgramStephensonCancerCenterAssociateProfessor,SectionofGynecologicOncologyDirector,GynecologicOncologyFellowshipDepartmentofObstetricsandGynecologyUniversityofOklahomaHealthSciencesCenterOklahomaCity,Oklahoma

Advisory Committee: AdvaxisInc,AmgenInc,AstraZenecaPharmaceuticalsLP,BoehringerIngelheimPharmaceuticalsInc,GenentechBioOncology,PfizerInc,RocheLaboratoriesInc.




ThisactivityissupportedbyeducationalgrantsfromAstraZenecaPharmaceuticalsLPandGenentechBioOncology.


AudehMWetal.Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recur-rent ovarian cancer: A proof-of-concept trial.Lancet2010;376(9737):245-51.

ColemanRLetal.A phase III randomized controlled clinical trial of carboplatin and paclitaxel alone or in combination with bevacizumab followed by bevacizumab and secondary cytoreductive surgery in platinum-sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer (Gynecologic Oncology Group 0213). Proc SGO 2015;Abstract 3.

HowellSBetal. Intraperitoneal cisplatin with systemic thiosulfate protection. Ann Intern Med 1982;97(6):845-51.

IglehartJD,SilverDP.Synthetic lethality — A new direction in cancer-drug development.N Engl J Med2009;361(2):189-91.

KaufmanBetal.Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation.J Clin Oncol2015;33(3):244-50.

KennedyRD,D'AndreaAD.DNA repair pathways in clinical practice: Lessons from pediatric cancer susceptibility syndromes. J Clin Oncol 2006;24(23):3799-808.

KhannaKKetal. ATM, a central controller of cellular responses to DNA damage. Cell Death Differ2001;8(11):1052-65.

LedermannJetal.Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: A preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial.Lancet Oncol2014;15(8):852-61.

LedermannJetal.Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012;366(15):1382-92.

LiuJetal.A randomized phase 2 trial comparing efficacy of the combination of the PARP inhibitor olaparib and the antian-giogenic cediranib against olaparib alone in recurrent platinum-sensitive ovarian cancer. Proc ASCO2014;Abstract LBA5500.

MatulonisUAetal.Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: A multistudy analysis of response rates and safety. Ann Oncol 2016;27(6):1013-9.

Pujade-LauraineEetal.Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial.J Clin Oncol 2014;32(13):1302-8.

Sánchez-Pérez.DNA repair inhibitors in cancer treatment.Clin Transl Oncol 2006;8(9):642-6.

VergoteIetal.Prognostic importance of degree of differentiation and cyst rupture in stage I invasive epithelial ovarian carci-noma. Lancet 2001;357(9251):176-82.

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ResearchToPractice.com/ONSLymphoma2016 1

TARGET AUDIENCEThisactivityhasbeendesignedtomeettheeducationalneedsofoncologynurses,nursepractitionersandclinicalnursespecialistsinvolvedinthetreatmentofHodgkinlymphoma(HL),non-Hodgkinlymphoma(NHL)andchroniclymphocyticleukemia(CLL).

OVERVIEW OF ACTIVITYHematologiccancersincludethelymphomas,theleukemias,multiplemyelomaandotherrelateddisorders(eg,myelodys-plasticsyndromes,myeloproliferativediseases)stemmingfromlymphoidandmyeloidprogenitorcelllines.Takentogether,itisestimatedthatapproximately171,550newlymphoid,myeloidandleukemiccancercaseswillbeidentifiedintheUnitedStatesintheyear2016and58,320individualswilldiefromthesediseases.Ofnote,morethan60drugproductsarecurrentlylabeledforuseinthemanagementofhemato-logiccancerswithmorethan70distinctFDA-approvedindica-tions.Althoughthisextensivelistofavailabletreatmentoptionsisreassuringforpatientsandoncologyhealthcareprofessionals,itposesachallengetothepracticingclinicianwhomustmaintainup-to-dateknowledgeofappropriateclinicalmanagementstrategiesacrossavastspectrumofliquidandsolidtumors.ThisisparticularlytruewithintherealmofHodgkinandnon-Hodgkinlymphoma,includingCLL,wheresubstantialprogresshasbeenmadeoverthepastseveralyearsinthedevelopmentandevaluationofnovelagents.Matureclinicaltrialresultshaveillustratedtheefficacyofseveralnewinvestigationaltherapies,anumberofwhichhavenowenteredtheclinic.Furthermore,enthusiasmiswidespreadthatadditionalimportantadvancementsareonthehorizonasothernovelagentsandstrategieshavealreadybeenassociatedwithimpressiveclinicalbenefit.

Thisdynamictherapeuticenvironmentclearlyhighlightstheneedforallmembersoftheoncology/hematologycareteamtoremainabreastoftheongoingseachangeinthemanagementofthesediseases,particularlyoncologynurses,whoplayanintegralroleinthesuccessfuldeliveryofsystemicanticancertherapyandthepreservationofpatientphysicalandpsycho-socialwell-being.Thesevideoproceedingsfromthesixthpartofan8-partintegratedCNEcurriculumoriginallyheldatthe2016ONSAnnualCongressfeaturediscussionswithleadingoncologyinvestigatorsandtheirnursingcounterpartsregardingactualpatientcasesandrecentclinicalresearchfindings

affectingtheoptimaltherapeuticandsupportivecareforeachpatientscenario.

PURPOSE STATEMENTByprovidinginformationonthelatestresearchdevelopmentsinthecontextofexpertperspectives,thisCNEactivitywillassistoncologynurses,nursepractitionersandclinicalnursespecialistswiththeformulationofstate-of-the-artclinicalmanagementstrategiestofacilitateoptimalcareofpatientswithlymphomasandCLL.

LEARNING OBJECTIVES• Providepatient-focusededucationtoenhanceclinical

decision-makingregardingtheavailablesystemicagentsusedinthemanagementofindolentandaggressiveformsofB-cellNHL,T-celllymphomasandHL.

• FormulatesupportivecarestrategiestomanagethesideeffectsassociatedwithcommonlyemployedtherapeuticinterventionsforpatientswithHL,NHLandCLL.

• AppreciatetheFDAapprovalsofthenoveltargetedagentsibrutinib,idelalisibandobinutuzumabforthetreatmentofnewlydiagnosedandrelapsed/refractory(R/R)CLL,anddiscernhowthesetherapiescanbesafelyintegratedintoroutineclinicalpractice.

• Recallavailablesafetyandefficacydatawithbortezomib,lenalidomideandibrutinib,andusethisinformationwhendiscussingrecommendationsregardingtheselectionandsequencingoftherapyforR/Rmantle-celllymphoma.




CNE Information

Oncology Grand Rounds Series:Part 6 — Lymphomas and

Chronic Lymphocytic Leukemia




FOR SUCCESSFUL COMPLETIONThisisavideoCNEprogram.Toreceivecredit,participantsshouldreadthelearningobjectivesandfacultydisclosures,watchthevideo,completethePost-testwithascoreof75%orbetterandfillouttheEducationalAssessmentandCreditFormlocatedatResearchToPractice.com/ONSLym-phoma2016/CNE.



Michelle A Fanale, MDAssociateProfessorDepartmentofLymphomaandMyelomaatTheUniversityofTexasMDAndersonCancerCenterHouston,Texas

Consulting Agreements: Merck,SpectrumPharmaceuticalsInc;Contracted Research: Bristol-MyersSquibbCompany,CelgeneCorporation,GenentechBioOncology,GileadSciencesInc,MedImmuneInc,Merck,NovartisPharmaceuticalsCorpo-ration,OnyxPharmaceuticals,anAmgensubsidiary,SeattleGenetics,TakedaOncology; Data and Safety Monitoring Board: AmgenInc;Honoraria: Merck,SpectrumPharmaceu-ticalsInc,SeattleGenetics,TakedaOncology.

Amy Goodrich, CRNP-ACNursePractitionerJohnsHopkinsKimmelCancerCenterBaltimore,Maryland


John P Leonard, MDRichardTSilverDistinguishedProfessorofHematologyandMedicalOncologyAssociateDeanforClinicalResearchWeillCornellMedicalCollegeNewYork,NewYork

Consulting Agreements: ADCTherapeuticsSA,BayerHealthCarePharmaceuticals,BoehringerIngelheimPharma-ceuticalsInc,CelgeneCorporation,EisaiInc,GileadSciencesInc,HospiraInc,MedImmuneInc,MiratiTherapeutics,NovartisPharmaceuticalsCorporation,PfizerInc,ProNAiTherapeuticsInc,SeattleGenetics,TevaOncology.

Katey Stephans, MS, ANPNursePractitionerDivisionofHematologicMalignanciesLymphomaandStemCellTransplantProgramsDana-FarberCancerInstituteBoston,Massachusetts






ThisactivityissupportedbyeducationalgrantsfromAbbVieInc,CelgeneCorporation,GenentechBioOncology,JanssenBiotechInc,PharmacyclicsLLC,anAbbVieCompanyandSeattleGenetics.






AlduaijWetal.Novel type II anti-CD20 monoclonal antibody (GA101) evokes homotypic adhesion and actin-dependent, lysosome-mediated cell death in B-cell malignancies. Blood2011;117(17):4519-29.

AnsellSMetal.PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med 2015;372(4):311-9.

BurgerJAetal.Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med2015;373(25):2425-37.

ChenRWetal. Results of a phase II trial of brentuximab vedotin as first line salvage therapy in relapsed/refractory HL prior to AHCT.Proc ASH2014;Abstract 501.

DavidsMS,LetaiA.ABT-199: Taking dead aim at BCL-2. CancerCell2013;23(2):139-41.

DöhnerHetal.Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med 2000;343(26):1910-6.

FowlerNHetal.Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: An open-label, phase 2 trial. Lancet Oncol2014;15(12):1311-8.

GoedeVetal.Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med 2014;370(12):1101-10.

GopalAKetal.PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med 2014;370(11):1008-18.

HerterSetal.Superior efficacy of the novel type II, glycoengineered CD20 antibody GA101 versus the type I CD20 antibodies rituximab and ofatumumab. Proc ASH2010;Abstract 3925.

JacobsenEDetal.Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression. Blood 2015;125(9):1394-402.

LampsonBLetal.Idelalisib given front-line for the treatment of chronic lymphocytic leukemia results in frequent and severe immune-mediated toxicities. Proc ASH2015;Abstract 497.

LeGouillSetal.Rituximab maintenance versus wait and watch after four courses of R-DHAP followed by autologous stem cell transplantation in previously untreated young patients with mantle cell lymphoma: First interim analysis of the phase III prospective LyMa trial, a LYSA study. Proc ASH2014;Abstract 146.

LeonardJPetal.Randomized trial of lenalidomide alone versus lenalidomide plus rituximab in patients with recurrent follic-ular lymphoma: CALGB 50401 (Alliance). J Clin Oncol 2015;33(31):3635-40.

MoskowitzCHetal.Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015;385(9980):1853-62.

MoskowitzCHetal.PD-1 blockade with the monoclonal antibody pembrolizumab (MK-3475) in patients with classical Hodgkin lymphoma after brentuximab vedotin failure: Preliminary results from a phase 1b study. Proc ASH 2014;Abstract 290.

MössnerEetal.Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity. Blood2010;115(22):4393-402.

NiederfellnerGetal.Epitope characterization and crystal structure of GA101 provide insights into the molecular basis for type I/II distinction of CD20 antibodies. Blood 2011;118(2):358-67.

PeyradeFetal. Attenuated immunochemotherapy regimen (R-miniCHOP) in elderly patients older than 80 years with diffuse large B-cell lymphoma: A multicentre, single-arm, phase 2 trial. Lancet Oncol 2011;12(5):460-8.

SehnLHetal.GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with benda-mustine alone in patients with rituximab-refractory indolent non-Hodgkin lymphoma. Proc ASCO2015;Abstract LBA8502.

StilgenbauerSetal.Venetoclax (ABT-199/GDC-0199) monotherapy induces deep remissions, including complete remission and undetectable MRD, in ultra-high risk relapsed/refractory chronic lymphocytic leukemia with 17p deletion: Results of the pivotal international phase 2 study. Proc ASH 2015;Abstract LBA-6.

SweetenhamJetal.Updated efficacy and safety data from the AETHERA trial of consolidation with brentuximab vedotin after autologous stem cell transplant (ASCT) in Hodgkin lymphoma patients at high risk of relapse.Proc ASH2015;Abstract 3172.

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VillasboasJC,AnsellS. Checkpoint inhibition: Programmed cell death 1 and programmed cell death 1 ligand inhibitors in Hodgkin lymphoma. Cancer J2016;22(1):17-22.

WangMLetal.Ibrutinib and rituximab are an efficacious and safe combination in relapsed mantle cell lymphoma: Preliminary results from a phase II clinical trial. Proc ASH2014;Abstract 627.

WangMetal. Oral lenalidomide with rituximab in relapsed or refractory diffuse large cell, follicular and transformed lymphoma: A phase II clinical trial. Leukemia 2013;27(9):1902-9.

WangMLetal.Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med 2013;369(6):507-16.

WoyachJAetal.The B-cell receptor signaling pathway as a therapeutic target in CLL. Blood 2012;120(6):1175-84.

YasenchakCAetal.Brentuximab vedotin in combination with dacarbazine or bendamustine for frontline treatment of Hodgkin lymphoma in patients aged 60 years and above: Interim results of a multi-cohort phase 2 study. Proc ASH 2015;Abstract 587.

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ResearchToPractice.com/ONSMelanoma2016 1

TARGET AUDIENCEThisactivityhasbeendesignedtomeettheeducationalneedsofoncologynurses,nursepractitionersandclinicalnursespecialistsinvolvedinthetreatmentofmelanoma.

OVERVIEW OF ACTIVITYDespiteincreasedawarenessandextensiveattemptstopublicizeriskfactorsandscreening,currentestimatessuggestthat76,380menandwomenwillbediagnosedwithmelanomaand10,130individualswilldiefromthediseasein2016withintheUnitedStatesalone.Becauseofitscutaneouslocationanditshighmetastaticpotential,melanomamanagementremainsamajorclinicalchallenge,and,untilrecently,treatmentsforadvanceddiseasehadbeenrelativelylimitedintheiroveralleffectiveness.Morerecently,unprecedentedstrideshavebeenmadeindefiningmolecularmechanismsofcriticalimportancetomelanomadevelopment,progressionandmetastasis,knowledgewhichhasultimatelyyieldedanumberofnewagentsthathavebeenheraldedasmajorbreakthroughsbythemelanomacommunity.

This“openingofPandora’sbox”withregardtotheavail-abilityofnewtherapieshaschallengedpracticingclinicianstoquicklyunderstandhowbesttosafelyintegratethemintocurrentmanagementalgorithms.Thisisparticularlytrueamongoncologynursesandnursepractitioners,whoplayanintegralroleinthesuccessfuldeliveryofsystemicanticancertherapyandinthepreservationofpatientphysicalandpsychosocialwell-being.Thesevideoproceedingsfromtheseventhpartofan8-partintegratedCNEcurriculumoriginallyheldatthe2016ONSAnnualCongressfeaturediscussionswithleadingdermatologiconcologyinvestigatorsandtheirnursingcounterpartsregardingactualpatientcasesandrecentclinicalresearchfindingsaffectingtheoptimaltherapeuticandsupportivecareforeachpatientscenario.

PURPOSE STATEMENTByprovidinginformationonthelatestresearchdevelopmentsinthecontextofexpertperspectives,thisCNEactivitywillassistoncologynurses,nursepractitionersandclinicalnursespecialistswiththeformulationofstate-of-the-artclinicalmanagementstrategiestofacilitateoptimalcareofpatientswithmelanoma.

LEARNING OBJECTIVES• Discussthebenefitsandrisksassociatedwithsystemic

therapiesusedintheevidence-basedtreatmentofadjuvantandmetastaticmelanoma,includingimmunotherapeuticstrategiesandtargetedbiologicagents.

• RecognizetheFDAapprovalsofnivolumab,pembrolizumabandthecombinationofnivolumabandipilimumabforthemanagementofmetastaticmelanoma,andunderstandhowtheseapproachesfitintocurrenttreatmentalgorithms.

• RecallexistingandemergingresearchinformationdemonstratingtheimpactofcombiningBRAFandMEKinhibitorsforpatientswithBRAFmutation-positivemetastaticmelanoma,andusethisinformationtoguidetreatmentplanningfortheseindividuals.

• Developaplantomanagethesideeffectsassociatedwithimmunecheckpointinhibitorsandnoveltargetedagentstosupportqualityoflifeandcontinuationoftreatment.

• Appreciatethenovelmechanismofaction,endorsedclinicalroleandpracticaladministrationrequirementsoftalimogenelaherparepvectosupportthesafeandeffectiveintegrationofthisagentintocurrentpatientcare.





ONCCreviewisonlyfordesignatingcontenttobeusedforrecertificationpointsandisnotforCNEaccreditation.CNEprogramsmustbeformallyapprovedforcontacthoursbyanacceptableaccreditor/approverofnursingCEtobeusedfor

CNE Information

Oncology Grand Rounds Series:Part 7 — Melanoma


recertificationbyONCC.IftheCNEproviderfailstoobtainformalapprovaltoawardcontacthoursbyanacceptableaccrediting/approvalbody,noinformationrelatedtoONCCrecertificationmaybeusedinrelationtotheprogram.

FOR SUCCESSFUL COMPLETIONThisisavideoCNEprogram.Toreceivecredit,participantsshouldreadthelearningobjectivesandfacultydisclosures,watchthevideo,completethePost-testwithascoreof75%orbetterandfillouttheEducationalAssessmentandCreditFormlocatedatResearchToPractice.com/ONSMelanoma2016/CNE.



Katherine Benchich, MSN, ANP, OCN UniversityofColoradoCancerCenterCutaneousOncology

Aurora,Colorado


Adil Daud, MD ProfessorofMedicineUniversityofCaliforniaSanFrancisco,California

Advisory Committee: AmgenInc,GenentechBioOncology,GlaxoSmithKline,OncoSecMedical;Consulting Agreements: Bristol-MyersSquibbCompany,Merck,NovartisPharma-ceuticalsCorporation,OncoSecMedical,TakedaOncology;Contracted Research: Bristol-MyersSquibbCompany,GenentechBioOncology,GlaxoSmithKline,Merck,NovartisPharmaceuticalsCorporation,PfizerInc,RocheLaboratoriesInc,TakedaOncology.

Rene Gonzalez, MD ProfessorofMedicineDirector,MelanomaResearchClinicsUniversityofColoradoCancerCenterAurora,Colorado

Advisory Committee: AmgenInc,Bristol-MyersSquibbCompany,GenentechBioOncology,GlaxoSmithKline,RocheLaboratoriesInc; Consulting Agreements: AmgenInc,GenentechBioOncology,GlaxoSmithKline,NovartisPharma-ceuticalsCorporation; Contracted Research: AmgenInc,AstellasPharmaGlobalDevelopmentInc,AstraZeneca

PharmaceuticalsLP,Bristol-MyersSquibbCompany,CastleBiosciencesIncorporated,EisaiInc,GenentechBioOncology,GlaxoSmithKline,Merck,NovartisPharmaceuticalsCorpo-ration,RocheLaboratoriesInc,TakedaOncology;Other Remunerated Activities: NovartisPharmaceuticalsCorpo-ration.

Jason J Luke, MD AssistantProfessorofMedicineUniversityofChicagoChicago,Illinois

Consulting Agreements: AmgenInc,ArrayBioPharmaInc;Contracted Research: AbbVieInc,BBITherapeutics,Bristol-MyersSquibbCompany,CelldexTherapeutics,CorvusPharmaceuticals,DelcathSystemsInc,EMDSeronoInc,FivePrimeTherapeuticsInc,GenentechBioOncology,IncyteCorporation,MedImmuneInc,Merck,NovartisPharmaceu-ticalsCorporation,PharmacyclicsLLC,anAbbVieCompany.

Kathleen Madden, MSN, FNP, AOCNP, APHN NYULangonePerlmutterCancerCenterNewYorkUniversityNewYork,NewYork

Consulting Agreement: NovartisPharmaceuticalsCorporation;Speakers Bureau:Bristol-MyersSquibbCompany,DaiichiSankyoInc,GenentechBioOncology,Merck,NovartisPharma-ceuticalsCorporation.



This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not


recommend the use of any agent outside of the labeled indica-tions. Please refer to the official prescribing information for each product for discussion of approved indications, contra-indications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

ThisactivityissupportedbyeducationalgrantsfromAmgenInc,GenentechBioOncology,MerckandNovartisPharmaceu-ticalsCorporation.






AndtbackaRHIetal.Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol 2015;33(25):2780-8.

AndtbackaRHIetal.OPTiM: A randomized phase III trial of talimogene laherparepvec (T-VEC) versus subcutaneous (SC) granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment (tx) of unresected stage IIIB/C and IV melanoma. Proc ASCO2013;Abstract LBA9008.

FlahertyKTetal. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med2010;363(9):809-19.

FongL,SmallEJ. Anti-cytotoxic T-lymphocyte antigen-4 antibody: The first in an emerging class of immunomodulatory antibodies for cancer treatment. J Clin Oncol2008;26(32):5275-83.

KaufmanHLetal. Primary overall survival (OS) from OPTiM, a randomized phase III trial of talimogene laherparepvec (T-VEC) versus subcutaneous (SC) granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment (tx) of unresected stage IIIB/C and IV melanoma. Proc ASCO 2014;Abstract 9008a.

KaufmanHLetal.Local and distant immunity induced by intralesional vaccination with an oncolytic herpes virus encoding GM-CSF in patients with stage IIIc and IV melanoma.Ann Surg Oncol 2010;17(3):718-30.

LarkinJetal.Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2015;373(1):23-34.

LarkinJMGetal.Update of progression-free survival (PFS) and correlative biomarker analysis from coBRIM: Phase III study of cobimetinib (cobi) plus vemurafenib (vem) in advanced BRAF-mutated melanoma. Proc ASCO2015;Abstract 9006.

LarkinJetal.Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med 2014;371(20):1867-76.

LongGVetal.Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: A multicentre, double-blind, phase 3 randomised controlled trial. Lancet2015;386(9992):444-51.

RibasAetal. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): A randomised, controlled, phase 2 trial.Lancet Oncol2015;16(8):908-18.

RobertCetal.Pembrolizumab versus ipilimumab in advanced melanoma.N Engl J Med2015;372(26):2521-32.

WeberJSetal.Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treat-ment (CheckMate 037): A randomised, controlled, open-label, phase 3 trial.Lancet Oncol 2015;16(4):375-84.

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ResearchToPractice.com/ONSBladder2016 1

TARGET AUDIENCEThisactivityhasbeendesignedtomeettheeducationalneedsofoncologynurses,nursepractitionersandclinicalnursespecialistsinvolvedinthetreatmentofbladdercancer.

OVERVIEW OF ACTIVITYItisestimatedthat76,960newcasesofbladdercancerwillbediagnosedin2016and16,390deathswillbeattrib-utabletothisdisease.Althoughbladdercancerisaheteroge-neouscollectionofdiseases,morethan90%ofpatientsarediagnosedwithitsmostcommonform,urothelialcarcinoma.Optimaltreatmentofurothelialbladdercancer(UBC)isdependentuponthestageandgradeaswellaspreexistingpatientcomorbidities.Forthesegmentofpatientswhopresentwithordevelopmetastaticlesionsbeyondthebladder,thegoal,asisthecasewithmanyothersolidtumors,istoprolongthequantityandqualityoflife.Unfortunately,theonlynonpro-tocolsystemictreatmentavailabletotheseindividualsoverthepastfewdecadeshasbeenchemotherapy.However,itappearsthatamajorbreakthroughforthisdiseasehasfinallymaterializedintheformofimmunecheckpointinhibition.

Thisdevelopmentcoupledwiththediverseclinicalpresenta-tionsofUBCrequireanin-depthunderstandingamongalloftheinterdisciplinarytreatmentteammembersregardingtheoptimalworkupandtreatmentoftheseindividuals.Assuch,itremainsimperativethatmembersoftheoncologycommunity,includingnursesactivelyinvolvedinthecareofthesepatients,maintainup-to-dateknowledgeinthefaceofanincreasinglydynamicclinicalenvironment.Thesevideoproceedingsfromtheeighthpartofan8-partintegratedCNEcurriculumorigi-nallyheldatthe2016ONSAnnualCongressfeaturediscus-sionswithleadingoncologyandurologyinvestigatorsandtheirnursingcounterpartsregardingactualpatientcasesandrecentclinicalresearchfindingsaffectingtheoptimaltherapeuticandsupportivecareforeachpatientscenario.

PURPOSE STATEMENTByprovidinginformationonthelatestresearchdevelopmentsinthecontextofexpertperspectives,thisCNEactivitywillassistoncologynurses,nursepractitionersandclinicalnursespecialistswiththeformulationofstate-of-the-artclinicalmanagementstrategiestofacilitateoptimalcareofpatientswithbladdercancer.

LEARNING OBJECTIVES• Discussthebenefitsandrisksassociatedwithvarious

localand/orsystemictherapeuticapproachesusedinthetreatmentofnonmuscle-invasive,muscle-invasiveandmetastaticUBC.

• Developanevidence-basedalgorithmforthepreventionandameliorationofsideeffectsassociatedwithchemother-apeuticagents/regimensusedinthemanagementoflocallyadvancedormetastaticUBC.

• Developanunderstandingoftheavailabledataandpotentialclinicalroleoftheanti-PD-L1antibodyatezoli-zumabandotherimmunotherapiesinpreparationfortheirpotentialintroductionintoroutineclinicalpractice.

• Recognizeimmune-relatedadverseeventsandothercommonsideeffectsassociatedwithinvestigationalimmunotherapeuticapproaches,andusethisinformationtodevelopsupportivemanagementplansforpatientsundergoingtreatmentwiththeseagents.

• IdentifyopportunitiestoenhancethecollaborativeroleofoncologynursesinthecomprehensivebiopsychosocialcareofpatientswithUBC.





ONCCreviewisonlyfordesignatingcontenttobeusedforrecertificationpointsandisnotforCNEaccreditation.CNEprogramsmustbeformallyapprovedforcontacthoursbyanacceptableaccreditor/approverofnursingCEtobeusedfor

CNE Information

Oncology Grand Rounds Series:Part 8 — Bladder Cancer


recertificationbyONCC.IftheCNEproviderfailstoobtainformalapprovaltoawardcontacthoursbyanacceptableaccrediting/approvalbody,noinformationrelatedtoONCCrecertificationmaybeusedinrelationtotheprogram.

FOR SUCCESSFUL COMPLETIONThisisavideoCNEprogram.Toreceivecredit,participantsshouldreadthelearningobjectivesandfacultydisclosures,watchthevideo,completethePost-testwithascoreof75%orbetterandfillouttheEducationalAssessmentandCreditFormlocatedatResearchToPractice.com/ONSBladder2016/CNE.

CONTENT VALIDATION AND DISCLOSURESResearchToPractice(RTP)iscommittedtoprovidingitsparticipantswithhigh-quality,unbiasedandstate-of-the-arteducation.Weassesspotentialconflictsofinterestwithfaculty,plannersandmanagersofCNEactivities.Conflictsofinterestareidentifiedandresolvedthroughaconflictofinterestresolutionprocess.Inaddition,allactivitycontentisreviewedbybothamemberoftheRTPscientificstaffandanexternal,independentreviewerforfairbalance,scientificobjectivityofstudiesreferencedandpatientcarerecommendations.


Anastassia Daskalova, MSN, ANP-BC GenitourinaryMedicalOncologyTischCancerInstituteIcahnSchoolofMedicineatMountSinaiNewYork,NewYork


Matthew D Galsky, MD Director,GenitourinaryMedicalOncologyTischCancerInstituteAssociateProfessorofMedicineIcahnSchoolofMedicineatMountSinaiNewYork,NewYork

Advisory Committee:AstellasPharmaGlobalDevelopmentInc,GenentechBioOncology,NovartisPharmaceuticalsCorpo-ration;Contracted Research:Bristol-MyersSquibbCompany,CelgeneCorporation;Ownership Interest: DualTherapeutics.

Leonard G Gomella, MD TheBernardWGodwinProfessorofProstateCancerChairman,DepartmentofUrologyAssociateDirector,JeffersonSidneyKimmelCancerCenterClinicalDirector,JeffersonSidneyKimmelCancerCenterNetworkEditor-in-Chief,Canadian Journal of UrologyPhiladelphia,Pennsylvania

Advisory Committee:AbbottLaboratories,AstellasPharmaGlobalDevelopmentInc,BayerHealthCarePharmaceu-ticals,Merck;Consulting Agreements: DendreonCorporation,JanssenBiotechInc,Merck;Contracted Research:AstellasPharmaGlobalDevelopmentInc.

Elizabeth R Plimack, MD, MS Director,GenitourinaryClinicalResearchAssociateProfessor,DepartmentofHematology/OncologyFoxChaseCancerCenter,TempleHealthPhiladelphia,Pennsylvania

Advisory Committee: AcceleronPharma,Bristol-MyersSquibbCompany,GenentechBioOncology,NovartisPharmaceuticalsCorporation,PfizerInc,RocheLaboratoriesInc;Consulting Agreements: Bristol-MyersSquibbCompany,Lilly,PfizerInc;Contracted Research: AcceleronPharma,AstraZenecaPharmaceuticalsLP,Bristol-MyersSquibbCompany,GlaxoSmithKline,Lilly,Merck,PfizerInc.

Susan K Roethke, CRNP, MSN, ANP-BC, AOCNP GenitourinaryMedicalOncologyFoxChaseCancerCenterPhiladelphia,Pennsylvania

Consulting Agreements and Speakers Bureau: PfizerInc;Nurse Advisory Board: ExelixisInc.



This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indica-tions. Please refer to the official prescribing information for each product for discussion of approved indications, contra-indications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

ThisactivityissupportedbyaneducationalgrantfromGenentechBioOncology.


AmosSMetal.Autoimmunity associated with immunotherapy of cancer.Blood2011;118(3):499-509.

BatleviCLetal.Novel immunotherapies in lymphoid malignancies. Nat Rev Clin Oncol 2016;13(1):25-40.

ChinKetal.Treatment guidelines for the management of immune-related adverse events in patients treated with ipilimumab, an anti-CTLA4 therapy. Proc ESMO2008;Abstract 787P.

CowanNGetal.Neoadjuvant chemotherapy use in bladder cancer: A survey of current practice and opinions. Adv Urol2014;2014:746298.

HiranoFetal.Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity. Cancer Res2005;65(3):1089-96.

HollenbeckBKetal.Delays in diagnosis and bladder cancer mortality. Cancer2010;116(22):5235-42.

KeirMEetal.PD-1 and its ligands in tolerance and immunity.Annu Rev Immunol 2008;26:677-704.

MeleroIetal.Clinical development of immunostimulatory monoclonal antibodies and opportunities for combination.Clin Cancer Res 2013;19(5):997-1008.

MilowskyMIetal.Guideline on muscle-invasive and metastatic bladder cancer (European Association of Urology Guideline): American Society of Clinical Oncology clinical practice guideline endorsement.J Clin Oncol 2016;34(16):1945-52.

O’DonnellPHetal.Pembrolizumab (Pembro; MK-3475) for advanced urothelial cancer: Results of a phase IB study.Genito-urinaryCancersSymposium2015;Abstract 296.

PalSKetal.Adjuvant chemotherapy for bladder cancer: Using population-based data to fill a void of prospective evidence. J Clin Oncol2016;34(8):777-9.

PardollDM.The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer2012;12(4):252-64.

PetrylakDPetal. A phase Ia study of MPDL3280A (anti-PDL1): Updated response and survival data in urothelial bladder cancer (UBC).Proc ASCO 2015;Abstract 4501.

PlimackERetal.A phase 1b study of pembrolizumab (Pembro; MK-3475) in patients (Pts) with advanced urothelial tract cancer. Proc ESMO2014;Abstract LBA23.

PowlesTetal.MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature 2014;515(7528):558-62.

YinMetal. Neoadjuvant chemotherapy for muscle-invasive bladder cancer: A systematic review and two-step meta-analysis. Oncologist2016;21(6):708-15.

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oncology grand rounds series - research to practice...ansell s et al. nivolumab in patients (pts)...

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