Managing Metastatic Bone Lesions, Metastatic Disease, Osteosarcomas and Musculoskeletal Tumors By: Don Beringer, MD, Scott Davidson, MD and Kamal Ummed, MD Summer 2019 | Volume 6, Issue 3 Northside Hospital Cancer Institute: 404-531-4444 IN THIS ISSUE: In the News: Updates for Clinicians p2 Highlights From the 2019 Miami Breast Cancer Conference: Still Re-Imaging DCIS by Ryland Gore, MD p3 Highlights From the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting: p3 MONALEESA-7 Trial Shows Significant Improvement in Overall Survival With Ribociclib and Endocrine Therapy in Premenopausal Women With Advanced Hormone Receptor-Positive Breast Cancer by Gena Volas-Redd, MD p3 ENZAMET Trial Results Reveal a New Treatment Option for Men With Metastatic, Hormone-Sensitive Prostate Cancer by Pradeep Jolly, MD p4 New Advancements In Pancreatic Cancer Treatment Using Personalized Medicine Commentary by Katie Lang, MS, CGC p5 KEYNOTE-062 Study Demonstrates Immunotherapy Treatment Option for Patients with Advanced Gastric or Gastroesophageal Junction Cancers by Tariq Mahmood, MD p5 Expansion of Clinical Trial Inclusion Criteria Could Double the Percentage of Eligible Patients by Margaret Ferreira, MS, RN, OCN Elevating the Patient Experience at NHCI p6 Working As a Team To Build a Culture Of Safety by Dan Bailey, PhD Around Our Campuses and Community p7 Northside Hospital Forsyth Infusion Center Provider Features p7 NHCI Community Welcomes New Physician Upcoming Events p7 Continuing Education p7 Cancer Screening & Prevention p8 Community and Foundation Events Soft tissue and bone sarcomas represent less than one percent of all malignan- cies. Although there are over 70 subtypes of sarcomas, there is a general lack of familiarity with these tumors due to their rarity. For that reason, their evaluation and management are best undertaken in specialty high volume centers with experienced physicians utilizing a multidisciplinary team approach. Soft tissue sarcomas can be easily overlooked or difficult to diagnose because they can mimic many common benign soft tissue tumors. Additionally, they are usually asymptomatic early on, making delay in diagnosis a common occurrence. Evaluation requires appropriate imaging studies and a carefully planned tissue biopsy. Once a diagnosis is established, the patient is introduced to our multidisci- plinary team and presented at our weekly multidisciplinary conference. Treatment planning and monitoring of patients’ progress occurs within this team environ- ment. In 2018, over 180 sarcoma patients were presented and discussed during our multidisciplinary conferences, leading to over 50 sarcoma surgeries during that time period. The Sarcoma Program at NHCI has significant experience in the evaluation and treatment of patients with soft tissue sarcoma. We recently expanded the scope of our program with the addition of Don Beringer, MD, an orthopedic oncologist. With Dr. Beringer’s training and experience, patients with primary bone tumors, including sarcomas of bone and bone metastases, can be effectively managed at NHCI. Bone sarcomas are even less common than soft tissue sarcomas, having an incidence of 25% that of soft tissue sarcomas. The most common bone sarcoma, osteosarcoma, occurs in just less than 5 cases per million of the population. It pre- dominates in the adolescent to young adult age group and occurs more commonly in the extremities. Complete excision of these tumors is critical to satisfactory disease-free outcomes. Limb-sparing approaches are most common and require detailed imaging and treatment planning. Dramatic improvements in survival are associated with the development of effective chemotherapy, which is often done prior to tumor excision. The second most commonly occurring primary malignant bone tumor requiring an expert multidisciplinary approach is Ewing’s sarcoma, an extremely rare tumor that occurs in less than one person per million (U.S. popula- tion). Ewing’s sarcoma is 9-10 times more common in children and adolescents and those of Caucasian descent. Unlike osteosarcoma, Ewing’s sarcoma is sensitive to both radiation and chemotherapy, and surgery is sometimes unnecessary for local control. There are several other subtypes of primary bone tumors that are not particularly sensitive to either radiation or chemotherapy and require surgery as the mainstay of treatment. Among these are chondrosarcoma and giant cell tumor of bone. In the absence of a history of malignancy, the possibility of a primary malignant bone tumor must always be a concern. However, most focal abnormalities of bone are either benign bone tumors that have little chance of spread or metastatic dis- ease. Metastatic bone disease is very common in persons with known advanced (continued on page 2)
Transcript
Managing Metastatic Bone Lesions, Metastatic Disease, Osteosarcomas and Musculoskeletal TumorsBy: Don Beringer, MD, Scott Davidson, MD and Kamal Ummed, MD
p5KEYNOTE-062StudyDemonstrates ImmunotherapyTreatmentOption forPatientswithAdvancedGastricor GastroesophagealJunctionCancers by Tariq Mahmood, MD
p5ExpansionofClinicalTrialInclusion CriteriaCouldDoublethePercentageof Eligible Patients by Margaret Ferreira, MS, RN, OCN
Elevating the Patient Experience at NHCI
p6 Working As a Team To Build a Culture Of Safety by Dan Bailey, PhD
Around Our Campuses and Community
p7 Northside Hospital Forsyth Infusion Center
Provider Features
p7 NHCI Community Welcomes New Physician
Upcoming Events
p7 Continuing Education
p7 Cancer Screening & Prevention
p8 Community and Foundation Events
Softtissueandbonesarcomasrepresentlessthanonepercentofallmalignan-cies.Althoughthereareover70subtypesofsarcomas,thereisagenerallackoffamiliaritywiththesetumorsduetotheirrarity.Forthatreason,theirevaluationand management are best undertaken in specialty high volume centers with experiencedphysiciansutilizingamultidisciplinaryteamapproach.
Soft tissuesarcomascanbeeasilyoverlookedordifficult todiagnosebecausetheycanmimicmanycommonbenignsofttissuetumors.Additionally,theyareusuallyasymptomaticearlyon,makingdelayindiagnosisacommonoccurrence.Evaluation requiresappropriate imagingstudiesandacarefullyplanned tissuebiopsy.Onceadiagnosisisestablished,thepatientisintroducedtoourmultidisci-plinaryteamandpresentedatourweeklymultidisciplinaryconference.Treatmentplanningandmonitoringofpatients’progressoccurswithinthis teamenviron-ment.In2018,over180sarcomapatientswerepresentedanddiscussedduringourmultidisciplinary conferences, leading toover50sarcomasurgeriesduringthattimeperiod.
TheSarcomaProgramatNHCIhassignificantexperienceintheevaluationandtreatmentofpatientswithsofttissuesarcoma.WerecentlyexpandedthescopeofourprogramwiththeadditionofDonBeringer,MD,anorthopediconcologist.WithDr.Beringer’strainingandexperience,patientswithprimarybonetumors,includingsarcomasofboneandbonemetastases,canbeeffectivelymanagedatNHCI.Bonesarcomasareevenlesscommonthansofttissuesarcomas,havinganincidenceof25%thatofsofttissuesarcomas.Themostcommonbonesarcoma,osteosarcoma,occursinjustlessthan5casespermillionofthepopulation.Itpre-dominatesintheadolescenttoyoungadultagegroupandoccursmorecommonlyin theextremities.Completeexcisionof these tumors is critical to satisfactorydisease-freeoutcomes.Limb-sparingapproachesaremostcommonandrequiredetailedimagingandtreatmentplanning.Dramaticimprovementsinsurvivalareassociatedwiththedevelopmentofeffectivechemotherapy,whichisoftendonepriortotumorexcision.ThesecondmostcommonlyoccurringprimarymalignantbonetumorrequiringanexpertmultidisciplinaryapproachisEwing’ssarcoma,anextremelyraretumorthatoccursinlessthanonepersonpermillion(U.S.popula-tion).Ewing’ssarcomais9-10timesmorecommoninchildrenandadolescentsandthoseofCaucasiandescent.Unlikeosteosarcoma,Ewing’ssarcoma issensitivetobothradiationandchemotherapy,andsurgeryissometimesunnecessaryforlocalcontrol.Thereareseveralothersubtypesofprimarybonetumorsthatarenotparticularlysensitivetoeitherradiationorchemotherapyandrequiresurgeryasthemainstayoftreatment.Amongthesearechondrosarcomaandgiantcelltumorofbone.
IN THE NEWS: Updates for CliniciansManaging Metastatic Bone Lesions, Metastatic Disease, Osteosarcomas and Musculoskeletal Tumors(continued from page 1)
Highlights From the 2019 Miami Breast Cancer ConferenceStill Re-Imaging DCIS By Ryland Gore, MD
cancer, particularly those with lung, breast, and prostatecancer,butcanoccurfrommanyotherprimarysites,includ-ingcolon,thyroid,andkidney.Bonemetastasescanresultinseverepain,pathologicfracture,spinalcordcompression,weakness,andhypercalcemia.Whiletypicaltumorstagingdoesnotcallforanexhaustivesearchforbonemetastases,x-raysorotherimagingtestsshouldbedonewhenthereisconcernforpossibleboneinvolvementwithadvanceddis-ease.Thereareagrowingnumberoftreatmentsavailableformanagementofmetastaticbonedisease,includingradi-ationtherapy,bonestabilizingagents,endocrineortargetedtherapies,andsurgicalstabilizationoftumorsathighriskofpathologicfracture.Patientsinadvancedstagesofdiseaseoftenhavethepotentialformanyyearsofsurvival,soitisthe aim of themultidisciplinary sarcoma team to identify
Ductal carcinoma in situ (DCIS), a non-invasivebreast cancer, will affect almost 70,000 women in 2019.Thisdiseaseprocesscontinuestoeludesurgeons,medicaloncologists, radiation oncologists and researchers alike,despite the fact that it seems like a very straightforwardissue.Dr.NormanWolmark,notablechairmanandprincipalinvestigator with the National Surgical Adjuvant BreastandBowelProject(NSABP),notedduringthisyear’sMiamiBreastConferencethatitstreatmentisprimarilydrivenbythemediaandlaypress.Dr.Wolmarkspecificallymentioneda controversial cover article published by TIMEmagazine(October12,2015)thataskedthequestion,“WhatifIdecidetojustdonothing?”Thiscoupledwiththeassertionthatweareover-diagnosingandover-treatingbreastcancermadeforaveryrivetingconversation.
Priortotheextensiveresearchwehavenow,itwasbelievedthat DCIS was relatively homogenous and certain charac-teristics, such as high grade, estrogen and progesteronereceptornegativity,solidtype,andcomedonecrosis,madeDCISmore aggressive. The pendulum then swung in theotherdirectionanditwasbelievedthatDCISwassimilartoits lobular counterpart and patients could undergo closeobservationandendocrinetherapyforadequatecontrol.
For over 5 years, our Program has enjoyed great successin offering comprehensive treatment to an increasingnumber of patients throughout the Northside catchmentarea.StudiesperformedintheUSandinternationallyhaveconsistentlyshownimprovedoutcomesaswellasahigherincidence of limb-sparing procedures when sarcomas aremanaged at high-volume facilities employing a multidisci-plinaryteamapproach.Ourmultidisciplinaryteamapproach,so critical to thesuccessof theProgram, includessurgicaloncologists, radiationoncologists,andmedicaloncologistscommitted to the Sarcoma Program, along with sarcoma pathologists, plastic surgeons, and a sarcoma nursenavigator.
WenowknowthatDCISisheterogeneous,justlikeinvasivebreast cancer. At this year’sMiamiBreastConference, thequestionofhowtoapproachandproperly treatDCISwasagain up for debate. Dr. Wolmark presented several ran-domizedcontrolledtrialsthatareintheworksandattemptto elucidate the management of DCIS moving forward.Trialsmentioned included the LORIS (UK), COMET (PatientCenteredOutcomesResearchInstitute[PCORI]),andLORD(EORTC).
Currentlylackingfromallofthesetrialsistheopportunitytotapintothepatient’stumor’sgenomicinformationtoutilizethe DCIS recurrence score (RS). The DCIS RS is currently offered by several companies, such as Genomic Health(Oncotype DX DCIS) to predict the patient’s future risk ofan invasive or non-invasive recurrence to tailor treatmentappropriately.ThereisalsoawidegapinDCIStreatmentop-tions,rangingfrom“active”surveillancetosurgicalinterven-tion,adjuvantradiationtherapy,withorwithouthormonaltherapy.
Wehavealongwaytogobeforethereisaconsensusontheappropriate way to treat DCIS. However, with the studiesunderway,thereisrenewedhopeonthehorizonthatwewillbeabletoofferthebestoptionsforourpatientsinordertoproperlytreatthiscontroversialandvarieddiseaseprocess.
Summer 2019 | Volume 6, Issue 3
CANCER CARE NEWS 3
IN THE NEWS: Updates for CliniciansHighlights From the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting
MONALEESA-7 Trial Shows Significant Improvement in Overall Survival With Ribociclib and Endocrine Therapy in Premenopausal Women With Advanced Hormone Receptor-Positive Breast Cancer By Gena Volas-Redd, MD
TheFDAapprovedthefirstoralCDK4/6inhibitorpalbociclibinFebruary2015fornewlydiagnosed,metastatichormonereceptor-positivebreastcancerinconjunctionwithletrozole.In the landmarkPALOMA-2 trial, the combination showedsuperiorprogression-freesurvival(PFS)comparedwitharo-matase inhibitor (AI) therapyalone.1Afterthispivotaltrial,camethepublicationandeventualapprovalofribociclibinthecriticalMONALEESA-2trialaswellasabemaciclibintheMONARCHtrials.Allthreedrugshavebeenapprovedinthefront-linesettingaswellastheAI-refractorysetting.
MONALEESA-7wasuniqueinitsdesigninthatthiswasatrialdedicated exclusively to premenopausal women with ad-vancedhormonereceptor-positivebreastcancerwhocouldhavereceiveduptoonelineofcytotoxictherapy.Thisphase3 trialwasoriginallypresentedat theSanAntonioBreastCancer Symposium in 2017 by Dr. Debu Tripathy.2 Of the 672patientsenrolledinthisclinicaltrial,335wererandomlyassignedtoribociclib inconjunctionwitheither tamoxifenoranonsteroidalAIalongwithgoserelin.Theadditional337patientswererandomlyassignedtoplaceboincombinationwiththesamehormonaltherapyoptionandgoserelin.TheprimaryendpointwasPFS,andthisendpointwassuccess-fully achieved. The median PFS was 23.8 months in theribociclibarmascomparedto13monthsintheplaceboarm.
The secondary endpoint of overall survival (OS) waspresentedintheupdateatASCO2019byDr.SaraHurvitzfromUCLA.3After42monthsoffollow-up,thesurvivalratewas70%forwomentreatedwiththecombinationtherapy
Traditionaltherapyformetastatichormonesensitivepros-tatecancer(mHSPC)hasbeenandrogendeprivationtherapy(ADT)with luteinizinghormone-releasinghormone (LHRH)agonists/antiandrogenssuchasbiclutamide/flutamide.Thestandard of care changed based on clinical trial findingsshowingimprovedoutcomeswiththeadditionofdocetaxelandandrogen-receptor-axistargeteddrugs(ARATs;eg,abi-raterone/prednisone, enzalutamide, apalutamide, darolut-amide)toADT(CHAARTED/LATITUDE/STAMPEDE/TITAN).
Results from the phase 3 ENZAMET trial have discoveredenzalutamideisabeneficialtreatmentoptionformenwithmetastatic, hormone-sensitive prostate cancer, especiallythosethatcannottoleratechemotherapy.1,2Atotalof1,125
compared to 46% who received endocrine therapy alonewithout ribociclib. Overall the therapy was well tolerated.Toxicitiesweremanageableandnodifferentthanoriginallyreported.Interestingly,itwasfoundthatthetamoxifen-gos-erelin combination had some QTc prolongation that wasaugmentedbyribociclib.Thus,theapprovalbyFDAforpre-menopausalpatientswaswithAIs,goserelinandribociclib,andnottamoxifen.NeutropeniawasthemostcommonsideeffectasisseenwithallCDK4/6inhibitors.Uniquetoriboci-clib(comparedtopalbociclibandabemaciclib)iselectrolyteandliverenzymemonitoringaswellasbaseline,week2and4QTcevaluations.
This is the first time a survival benefitwas demonstratedin premenopausal breast cancer patients and representsthelargestdatasetofanyCDK4/6inhibitoreverreported.Findingsdemonstratedarelativeriskreductionof29%intheribociclibtreatedpatientscomparedwithstandardhormon-altherapy.
Premenopausal women who present with advanced hor-monereceptor-positivebreastcancertendtohaveamoreaggressive clinical course compared to postmenopausalwomen.ThefactthatMONALEESA-7reportedastatisticallysignificantOSbenefitwillhopefullyhaveaglobalimpactincountriesthatrequirethisendpointfordrugapproval.
menwererandomizedtoreceiveaninjectionofatestoster-one-suppressing agent (goserelin, leuprolide, or degarelix)with either enzalutamide 160 mg daily or one of threestandardnonsteroidalantiandrogens(standard-caregroup).Additionally,503ofthe1,125enrolledpatientsreceivedearlydosesofdocetaxel.
FindingsoftheENZAMETtrialrevealedastatisticallysignif-icant improvement in overall survival in the enzalutamidegroup(P=0.002):afteranaverageof3years,80%ofpatientswhoreceivedenzalutamide(withorwithoutdocetaxel)werealive in comparison to 72% who received standard care.
(continued on page 4)
ENZAMET Trial Results Reveal a New Treatment Option for Men With Metastatic, Hormone-Sensitive Prostate CancerBy Pradeep Jolly, MD
Summer 2019 | Volume 6, Issue 3
CANCER CARE NEWS 4
IN THE NEWS: Updates for Clinicians
Pancreaticcanceristhe9thmostcommoncancerinwomenand the 10th most common cancer inmen with a 5-yearsurvival rate of 9%.1 In early 2019, it was estimated that56,770adultswouldbediagnosedwithpancreaticcancer.1However, the highly anticipated results from the phase 3POLOtrialreleasedatthisyear’sASCOmayhavediscoveredsomethingthatcanhelptoalterthesestatistics.
Results showed that olaparib reduced the risk of diseaseprogression by 47% (hazard ratio = 0.53; 95% confidenceinterval[CI],0.35to0.82;P=0.004)comparedwithplacebo.Also,33.7%ofpatientsreceivingolaparibshowednosignsofdiseaseprogressionafteroneyearvs14.5%ofpatientsreceiving placebo. While the results are encouraging, itshould be noted that 40% of patients receiving olaparibexperienced serious side effects (≥ grade 3) vs 23% ofpatientsreceivingplacebo,and5.5%discontinuedolaparibduetotoxicity.Therewasnoreporteddifferenceinqualityoflifebetweenthetwopatientgroups.1.Cancer.Net.PancreaticCancer: Statistics.https://www.cancer.net/cancer-types/pancreatic-cancer/statistics.AccessedonJuly9,2019.2. Kindler HL et al. Presented at ASCO 2019; Abstract LBA4. 2019; Chicago, IL.AbstractLBA4.
Furthermore,enzalutamidewassuperiortostandardcarein patients with either high (71% vs 64%) or low (90% vs82%)amountsofdiseaseon imagingscans. Itshouldalsobenotedthatnobenefitwasdeterminedwithdocetaxelinmenwithlow-volumedisease,butabenefitwasseenwithenzalutamide for this specific patient group. Fatigue wasmore commonwith enzalutamide, and seizures occurredin7patients(1%)intheenzalutamidegroupvsnoneinthestandard-care group. These results coupled with findingsfromsimilartrialswillformalargedataset(>10,000patients)for investigatorstoascertainthemosteffectivetreatmentoptionsforspecificsubsetsofmenwithmetastaticprostatecancer.
Highlights From the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (continued)ENZAMET Trial Results Reveal a New Treatment Option for Men With Metastatic, Hormone-Sensitive Prostate Cancer (continued from page 3)
TheENZAMETtrialaddstothebodyofdatademonstratingthatADTalone is not sufficient in achieving thebest out-comesforpatientswithHSPC.TheadditionofARATstoADTisanimportantadvancementinthestandardorcareforthispatientpopulationandshowshowbesttoselectthevariousavailableagents.ForARATs,thechoicemaycomedowntothetrade-offsoftoxicityandcost.
New Advancements In Pancreatic Cancer Treatment Using Personalized Medicine
Commentary By Katie Lang, MS, CGC
PARPinhibitorshavebeenprovensuccessful intreatingbreast and ovarian cancer in other studies, but this isthefirsttimeabenefitwasshownforpatientswithpan-creaticcancer.ItisimportanttonotethatmostpatientswhodeveloppancreaticcancerdonothaveaninheritedBRCA1 or BRCA2 mutation; however, the results of thisstudyhighlighttheimportanceofaccesstogeneticcoun-seling and testing for these patients. Current NationalComprehensive Cancer Network (NCCN) guidelines rec-ommendgenetictestingforallpancreaticcancerpatients,regardlessoffamilyhistory.1.Breindl,A.ASCO2019:POLObringsPARPtopancreas.BiolWorld.http://www.bioworld.com/content/asco-2019-polo-brings-parp-pancreas-0. Accessed onJuly9,2019.
This past June, exciting new advancements inthe treatment of pancreatic cancer were announced attheASCOmeetinginChicago.ResultsfromthePOLOtrialfoundthatforpatientswithmetastaticpancreaticcancerwhohadaninheritedmutationintheBRCA1 or BRCA2gene,andhadbeentreatedwithplatinum-basedchemotherapy,progression free survival doubled (3.8 to 7.4months) inpatientstreatedwithaPARPinhibitor(olaparib/Lynparza®)inthemaintenancesetting.1
Summer 2019 | Volume 6, Issue 3
CANCER CARE NEWS 5
Eligibility criteria are a crucial safety componentof clinical trials. They are created to ensure participantswho enroll are of a similar baseline health and activitylevel,have thesame typeofcancer,andhavehadsimilarprevioustreatments.Fosteringahomogeneouspopulationselection through enrollment to trialsmay lead to betteroutcomes.However,ascancertreatmentandcarecontinuetoevolve,anddrugscometomarketmuchfaster,theimpactofnewdrugsonmorediversepopulationsisyettobefullyunderstood. Too often, restrictive eligibility criteria havebeenabarrier toenrollment formanywillingparticipantsfrom diverse backgrounds. Diversity in clinical trialenrollmentbringswith it thechallengesofweighingstudydesignandpatientsafetythrougheligibilitycriteriaagainstcommonco-morbiditiesobserved indifferentpopulationsthatmayexcludeparticipantsfromenrolling.
Thiswasthebasisfortheanalysisofhealthrecordsofmorethan 10,500 non-small cell lung cancer (NSCLC) patientsreportedbyDr.R.DonaldHarveyatthisyear’sannualASCOmeeting.1 According to Dr. Harvey, “changes to eligibilitycriteria are particularly important aswe step further intotheeraof targeted therapies, including immunotherapies,thathavedifferentsafetyprofilesthanhighlytoxicsystemicchemotherapies.”2
IN THE NEWS: Updates for Clinicians
The idea of expanded clinical trial inclusion criteria wasfirst proposed in 2017 by ASCO and Friends of CancerResearch.Asaresult,in2018theNationalCancerInstitute(NCI)reviseditsclinicaltrialtemplatetobroadeneligibilitycriteria.Dr.Harveyandhisco-authorsreviewedelectronichealthrecordsfromASCO’sCancerLinQdatabasefrom2011to2018andfoundthatwithexpandedinclusioncriteria,thepercentage of eligible advanced NSCLC patients jumpedfrom52.3%to98.5%(see Figure below).
KEYNOTE-062 Study Demonstrates Immunotherapy Treatment Option for Patients with Advanced Gastric or Gastroesophageal Junction CancersBy Tariq Mahmood, MD
Expansion of Clinical Trial Inclusion Criteria Could Double the Percentage of Eligible PatientsBy Margaret Ferreira, MS, RN, OCN
Highlights From the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (continued)
Thestandardfirst-linetreatmentforadvancedgastricorgas-troesophagealjunction(GEJ)carcinomasiscombinationcy-totoxicchemotherapy.Resultsofthephase3KEYNOTE-062study were eagerly awaited to potentially challenge thisparadigmbyofferinganimmunotherapytreatmentoptionforpatientswithnewlydiagnosedadvancedgastricorGEJcancers.
Atotalof763patientswithHER2-negativeandPD-L1-positive(CPSscore>1)locallyadvancedunresectableormetastaticgastric orGEJ adenocarcinomawere randomized to treat-ment in one of three groups: (1) pembrolizumab alone; (2)pembrolizumab+chemotherapy;or(3)placebo+chemo-therapy.1FindingsshowedthatforCPS>1,pembrolizumabmonotherapywasnoninferiortochemotherapyalonewithstatistically similar overall survival. The pembrolizumabmonotherapy arm demonstrated significant reduction
in adverse events (AE). Interestingly a CPS score of 10 ormore did confer a statistically significant survival benefitforpembrolizumabvs.chemotherapy(2-yearOS39%withpembrolizumab vs 22% with chemotherapy). Finally, theaddition of pembrolizumab chemotherapy conferred noadditionalbenefitandshouldnotbeemployed.
Insummary,thistrialmetitsendpoints,butdidnotdemon-stratethesuperiorityofpembrolizumabtochemotherapyin first-line management of gastric cancer. It did providerationaleforfirst-linesingle-agentuseofpembrolizumabinCPS>1inpatientswithcomorbidityortheelderly,givenitisnon-inferiortochemotherapywithcorrespondingreductioninadverseevents.ForthosepatientswithCPSof10ormore,single-agent pembrolizumab appears to confirm survivalbenefitandshouldbeconsidered.1.TaberneroJ,etal.PresentedatASCO2019;AbstractLBA4007.
(continued on page 6)
Dr. Harvey notes that increased knowledge of drug-specific and population-specific outcomes is necessary to
Examples of the expanded inclusion criteria included:•Olderpatients,raisingthemedianagefrom 66.1to67.5years
Elevating the Patient Experience at NHCIElevating the Patient Experience at NHCI
Highlights From the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (continued)Expansion of Clinical Trial Inclusion Criteria Could Double the Percentage of Eligible Patients (continued from page 5)
ensure that eligibility criteria expansion happens quicklyand safely. Expanding eligibility requirements helps toensure that participants in trials more accurately reflectthe diverse populations who will ultimately receive newdrugtreatments inthecommunityasstandardofcare. Inaddition to increasing the eligible patient population, theexpansionofinclusioncriteriamayalsohelptoreducesocialandeconomicdisparitiesinenrollmentforclinicaltrials.
The Northside Hospital Cancer Institute (NHCI)iscommittedtoprovidingtreatmentsthatutilizethemostrecent advancements in tumor targeting and radiationdelivery technology, but surrounding each and everytreatmentisaclinicalenvironmentdedicatedtothequalitycare and safety of every patient. We view safety as aninherentpartoftreatmentquality:ourgoalistonurtureacultureofsafetythataimstodelivereverytreatmentwith
InRadiationOncology,noindividualdisciplinestandsaloneoroperatesindependentlyofanyotherpartoftheclinicalteam. Recognizing this reality, our approach to patientsafetyismultidisciplinaryandfoundedonlisteningtoeachother,which is representedby three initiativescontinuallyunderwaythathighlightthiscommitment(see Figure).
Working as a Team to Build a Culture of SafetyBy Dan Bailey, PhD
Safety and Quality Measures
(continued on page 7)
Safety and Quality Measures
Safety Ambassador Program
Treatment Delivery and Imaging Quality Assurance (QA):
Another ongoing collaboration between medical physicists at all clinics, often with valuable input from dosimetrists and radiation therapists. Our purpose is to ensure adherence to the most up-to-date guidelines for dosimetric accuracy, mechanical precision and image-guided targeting for all of our treatment units. As treatment and QA technology rapidly changes, we aim to work smartly and meticulously to maintain the precision and accuracy of every treatment delivered at NHCI.
Treatment Plan Quality and Safety Checks
A continuous collaboration between physicians, dosimetrists, physicists and radiation thera-pists, we consult current clinical protocols, professional guidelines, and peer-reviewed publica-tions to implement dose analysis and safe delivery checks for every individual treatment plan.
AgoaloftheNorthsideHospitalGANCORPgrantistoaffordpatients the opportunity to participate in a clinical trialwithina50-mileradiusoftheirhome.Withseverallocationsspreadthroughoutthestate,GANCORPhastheopportunitytofurtherthegoalsoftheNCIasitcontinuestoevaluatetheimportanceofdiversityinclinicaltrialenrollmentbybringingresearchintothecommunity.1.HarveyRD,etal.PresentedatASCO2019;AbstractLBA108.2.TheASCOPost.2019ASCO:ExpansionofClinicalTrialInclusionCriteriainPatientsWith Advanced NSCLC. https://www.ascopost.com/News/60106. Accessed on July9,2019.
Summer 2019 | Volume 6, Issue 3
CANCER CARE NEWS 7
Around Our Campuses and CommunityTheexpansionoftheNorthsideHospitalForsythInfusionCenteropenedonMonday,July15!Patientsarecurrentlybeingseenatthe19bay,2procedureroomfacility,locatedinSuite300ofthe1100Building.
Upcoming EventsCONTINUING EDUCATIONGeorgia Surgical Society Annual Meeting September19-22,2019@TheWestinResortinJekyllIsland http://gasurgsociety.org/annual-meeting/GASCO’s 2019 Annual Meeting and ASCO Direct Highlights September20-21,2019@TheHotelatAvaloninAlpharetta https://www.gasco.us/meetings-topic.php?meetingid=1016
CANCER SCREENING & PREVENTIONProstate Cancer Screening August22,2019@NorthsideAlpharettaHospitalMedicalCampusfrom5:30-8pm October17,2019@NorthsideHospitalCancerInstitute,RadiationOncology–Atlanta,5:30-8pm https://www.northside.com/evc/Page.asp?PageID=EVC000111&date=2017-02-16T17:30:00&skinID=screeningsSkin Cancer Screening September19,2019@NorthsideHospitalCancerInstituteRadiationOncology–Atlantafrom6-8pm https://www.northside.com/evc/Page.asp?PageID=EVC000143&DateID=10557&Date=2019-09-19T18:00:00Community Prostate Cancer Screenings August10,2019@LaMisionCatholicChurchinpartnershipwiththeLatinAmericanAssociation 3344BufordHwyNE,Atlanta30329,10am-1pmSeptember28,2019@SouthsideMedicalCenter 1046RidgeAveSW,Atlanta30315,10am-1pmBuilt To Quit Smoking and Tobacco Cessation Class Session4:July9–August13,2019 Session5:September10–October15,2019 ClassesareavailableatvariouslocationsonornearNorthsideHospital campusesandbyvideoconferenceforremoteparticipants https://www.northside.com/evc/Page.asp?PageID=EVC000212
Elevating the Patient Experience at NHCI
Provider Features
Puttingallofthisinformationtogether,theprofessionalsatNHCIrealizeourtaskissimple,butconstantlychallenging:tobuildandmaintainacultureofsafetythatprospectivelystops accidents before they happen. By our philosophy,
Working as a Team to Build a Culture of Safety (continued from page 6)
NHCI Community Welcomes New PhysicianDr. IoanaBonta isaboard-certifiedphysician inmedicaloncologyand internalmedicinenowpracticingat theGeorgiaCancerSpecialistsCenterPointlocation.Shespecializesinsystemictherapiessuchasimmunotherapy,targetedtherapy,chemotherapyandcombinedmodalitiestotreatdifferenttypesofmalignancies.
Summer 2019 | Volume 6, Issue 3
CANCER CARE NEWS 8
Relay for Life Fayette August23,2019from6pm-midnight @PinewoodForestinFayetteville http://main.acsevents.org/site/TR/RelayForLife/RFLCY19SER?team_id=2364557&pg=team&fr_id=91385
SagerStrong Foundation and LLS 3K Stadium Fun Run August25,2019@6:30am @SunTrustPark https://sagerstrongfoundation.org/registration- august-25-2019-sagerstrong-foundation-lls-fun-run/
Team Maggie 5K/10K September14,2019from7:30-10:30am @King'sCourtChapelinRoswell https://runsignup.com/Race/GA/ROSWELL/teammaggie5k10k
COMMUNITY EVENTS
FOUNDATION EVENTS
Upcoming Events
Georgia 2-Day Walk for Breast Cancer October5,2019@7am–October6,2019@12pm Starts@AtlantaMarriottMarquis https://itsthejourney.org
Leukemia & Lymphoma Society Light the Night October5,2019@7:30pm @PiedmontPark https://www.lightthenight.org/events/atlanta?gclid=CjwKCAjw5pPnBRBJEiwAULZKvgpllWZ-mw6ul6m063JfUd7IAwzwP49dZ6MYFrJzfNU9JVbTN3Q-XBoCXYAQAvD_BwE&gclsrc=aw.ds
Survivors Reunion for the Northside Hospital Cancer Institute Blood & Marrow Transplant Group October12,2019from6-10pm @Mercedes-BenzStadium
Wine Women & Shoes September15,2019from1-4pm @GrandHyattAtlantainBuckhead ProceedsfromWW&SbenefittheLeukemiaand Women’sCancerProgramsatNorthsideHospital https://give.northside.com/events/wws/
Tennis Against Breast Cancer Benefits the Northside Hospital Breast Care Program October11,2019@CherokeeTBD October18,2019@LanierTech(ForsythCounty) October25,2019@AtlantaAthleticClub(JohnsCreek) https://give.northside.com/events/tennis-against-breast-cancer/
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