2024
Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors
Hu Y, Narayan A, Xu Y, Wolfe J, Vu D, Trinh T, Kantak C, Ivy S, Eder J, Deng Y, LoRusso P, Kim J, Patel A. Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors. JCO Precision Oncology 2024, 8: e2300289. PMID: 38412387, PMCID: PMC10914240, DOI: 10.1200/po.23.00289.Peer-Reviewed Original ResearchConceptsCell-free circulating tumor DNANon-small-cell lung cancerSmall-cell lung cancerTriple-negative breast cancerPancreatic ductal adenocarcinomaAdvanced solid tumorsVariant allele fractionRadiographic responseOverall survivalCombination therapySolid tumorsCtDNA levelsLung cancerPretreated advanced solid tumorsDays of combination therapyMetastatic pancreatic ductal adenocarcinomaResponse to anticancer therapyAssociated with disease progressionProgression-free survivalPlasma samplesLead-inPoly(ADP-riboseInferior OSTumor DNASurvival outcomes
2022
Effect of Androgen–Androgen Receptor Directed Therapy on COVID-19 Outcome in Prostate Cancer Patients
Ünlü S, Shin J, Par-Young J, Simonov M, Vinetz J, Petrylak D, Kang I, Kim J. Effect of Androgen–Androgen Receptor Directed Therapy on COVID-19 Outcome in Prostate Cancer Patients. Cancer Investigation 2022, 41: 77-83. PMID: 36373994, DOI: 10.1080/07357907.2022.2139839.Peer-Reviewed Original ResearchConceptsProstate cancer patientsCOVID-19 outcomesCancer patientsPoor COVID-19 outcomesAndrogen-androgen receptorExpression of TMPRSS2COVID-19 infectionSARS-CoV-2Directed therapyMean hospitalizationPCa patientsHospitalization ratesPCa casesRetrospective analysisOutcome differencesPatientsDefinitive conclusionsStatistical significanceData generate hypothesesHospitalizationTherapyTMPRSS2Cellular entryOutcomesARDTRandomized Trial of Olaparib With or Without Cediranib for Metastatic Castration-Resistant Prostate Cancer: The Results From National Cancer Institute 9984
Kim JW, McKay RR, Radke MR, Zhao S, Taplin ME, Davis NB, Monk P, Appleman LJ, Lara PN, Vaishampayan UN, Zhang J, Paul AK, Bubley G, Van Allen EM, Unlu S, Huang Y, Loda M, Shapiro GI, Glazer PM, LoRusso PM, Ivy SP, Shyr Y, Swisher EM, Petrylak DP. Randomized Trial of Olaparib With or Without Cediranib for Metastatic Castration-Resistant Prostate Cancer: The Results From National Cancer Institute 9984. Journal Of Clinical Oncology 2022, 41: 871-880. PMID: 36256912, PMCID: PMC9901975, DOI: 10.1200/jco.21.02947.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerRadiographic progression-free survivalMedian radiographic progression-free survivalCastration-resistant prostate cancerArm AProstate cancerAdverse eventsGrade 3Progressive metastatic castration-resistant prostate cancerEndothelial growth factor receptor inhibitorEnd pointHomologous recombination repair genesGrowth factor receptor inhibitorsPrimary end pointSecondary end pointsProgression-free survivalRecombination repair genesPoly (ADP-ribose) polymerase inhibitionTreat setTreat patientsClinical outcomesRandomized trialsPreclinical modelsReceptor inhibitorsCediranibEmerging Role of PARP Inhibitors in Metastatic Prostate Cancer
Unlu S, Kim JW. Emerging Role of PARP Inhibitors in Metastatic Prostate Cancer. Current Oncology Reports 2022, 24: 1619-1631. PMID: 35931885, DOI: 10.1007/s11912-022-01305-0.Peer-Reviewed Original ResearchConceptsPARP inhibitorsBRCA2 mutationsProstate cancerFDA approvalMetastatic prostate cancer patientsAccelerated FDA approvalDeleterious BRCA2 mutationsHRR gene mutationsObjective response ratePhase II studyMetastatic prostate cancerProstate cancer patientsPoly (ADP-ribose) polymerase (PARP) inhibitorsUS FDA approvalSomatic mutationsMCRPC patientsCombination regimenII studyClinical benefitRadium-223Cancer patientsStandard treatmentAndrogen receptorDNA damage repair pathwaysClinical developmentEffect of androgen receptor directed therapy in prostate cancer patients with COVID-19.
Unlu S, Shin J, Par-Young J, Vinetz J, Petrylak D, Kang I, Kim J. Effect of androgen receptor directed therapy in prostate cancer patients with COVID-19. Journal Of Clinical Oncology 2022, 40: 161-161. DOI: 10.1200/jco.2022.40.6_suppl.161.Peer-Reviewed Original ResearchProstate cancerPCa patientsAndrogen receptorCOVID-19Mortality rateYale New Haven Health SystemProtective rolePrevalence of PCaRate of hospitalRetrospective chart reviewExpression of TMPRSS2Rate of hospitalizationProstate cancer patientsAndrogen receptor antagonistProstate cancer casesSARS-CoV-2Institutional review boardDirected therapyChart reviewClinical characteristicsGnRH agonistHormone therapyGnRH antagonistHome medicationsClinical outcomes
2021
Digital Health for Optimal Supportive Care in Oncology: Benefits, Limits, and Future Perspectives
Aapro M, Bossi P, Dasari A, Fallowfield L, Gascón P, Geller M, Jordan K, Kim J, Martin K, Porzig S. Digital Health for Optimal Supportive Care in Oncology: Benefits, Limits, and Future Perspectives. Kompass Nutrition & Dietetics 2021, 1: 72-90. DOI: 10.1159/000519151.Peer-Reviewed Original ResearchSupportive careDigital health solutionsHealth solutionsHealth economic endpointsOncology supportive careRoutine supportive careHealthcare resource utilizationOptimal supportive careImprovement of QoLTreatment of symptomsPatient-centered careEvidence-based therapeutic interventionsDifferent healthcare systemsUnplanned hospitalizationMost patientsSymptom supportOncology practiceSymptom distressClinical studiesPatient managementOral drugsSymptom monitoringPatient complianceTreatment efficacyTherapeutic interventionsClinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation
Kim J, Cardin DB, Vaishampayan UN, Kato S, Grossman SR, Glazer P, Shyr Y, Ivy SP, LoRusso P. Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. The Oncologist 2021, 26: e1104-e1109. PMID: 33742489, PMCID: PMC8265343, DOI: 10.1002/onco.13758.Peer-Reviewed Original ResearchConceptsMetastatic pancreatic adenocarcinomaHomologous recombination DNA repair deficiencyMetastatic pancreatic ductal adenocarcinomaPancreatic ductal adenocarcinomaOlaparib combinationStable diseaseBRCA mutationsAdverse eventsDuctal adenocarcinomaCommon treatment-related adverse eventsVascular endothelial growth factor receptor inhibitorEndothelial growth factor receptor inhibitorTreatment-related adverse eventsGrowth factor receptor inhibitorsPrior systemic chemotherapyMedian overall survivalObjective response rateGermline BRCA mutationsBest overall responseExpression of BRCA1/2Restaging scanCancer cell linesPrimary endpointStudy drugSystemic chemotherapySapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC).
Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseaseAdverse eventsObjective responseWithdrew consentTSC2 mutationsUrothelial carcinomaTSC1 mutationsTumor samplesCommon adverse eventsMedian overall survivalTreatment-related deathsPhase II studyCentral labOverall response rateDual mTORC1/2 inhibitorUnknown mutational statusCentral confirmationEligible patientsEvaluable patientsMUC patientsRestaging scanII studyPrimary endpointBaseline characteristicsSafety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I StudyAtezolizumab in Castration-Resistant Prostate Cancer
Petrylak DP, Loriot Y, Shaffer DR, Braiteh F, Powderly J, Harshman LC, Conkling P, Delord JP, Gordon M, Kim JW, Sarkar I, Yuen K, Kadel EE, Mariathasan S, O'Hear C, Narayanan S, Fassò M, Carroll S, Powles T. Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I StudyAtezolizumab in Castration-Resistant Prostate Cancer. Clinical Cancer Research 2021, 27: 3360-3369. PMID: 33568344, DOI: 10.1158/1078-0432.ccr-20-1981.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerPartial responseProstate cancerAtezolizumab monotherapyOverall survivalPrior linesImmune-related response criteriaTreatment-related adverse eventsDose-expansion studyPSA response rateMedian overall survivalBiomarker analysisEvaluable patientsRECIST 1.1Adverse eventsOS ratesClinical benefitSafety profileDisease progressionAtezolizumabClinical activityRadiographic assessmentImmune responseLimited efficacy
2020
Cabozantinib plus docetaxel and prednisone in metastatic castration‐resistant prostate cancer
Madan RA, Karzai FH, Al Harthy M, Petrylak DP, Kim JW, Arlen PM, Rosner I, Theoret MR, Cordes L, Bilusic M, Peer CJ, Dawson NA, Couvillon A, Hankin A, Williams M, Chun G, Owens H, Marte JL, Lee M, Tomita Y, Yuno A, Trepel JB, Lee S, Steinberg SM, Gulley JL, Figg WD, Dahut WL. Cabozantinib plus docetaxel and prednisone in metastatic castration‐resistant prostate cancer. BJU International 2020, 127: 435-444. PMID: 32969563, PMCID: PMC8265825, DOI: 10.1111/bju.15227.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerDocetaxel/prednisoneCastration-resistant prostate cancerPhase 1 studyProstate cancerDose of cabozantinibEfficacy of cabozantinibPalmar-plantar erythrodysesthesiaPhase 1/2 trialPhase 2 studyOverall survival timeDocetaxel/Median TTPNeutropenic feverPoor accrualThromboembolic eventsMore patientsRandomized studyMedian timeMulticentre studyGrade 3Survival timeCabozantinibPrednisonePatientsDigital health for optimal supportive care in oncology: benefits, limits, and future perspectives
Aapro M, Bossi P, Dasari A, Fallowfield L, Gascón P, Geller M, Jordan K, Kim J, Martin K, Porzig S. Digital health for optimal supportive care in oncology: benefits, limits, and future perspectives. Supportive Care In Cancer 2020, 28: 4589-4612. PMID: 32533435, PMCID: PMC7447627, DOI: 10.1007/s00520-020-05539-1.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesSupportive careDigital health solutionsHealth solutionsHealth economic endpointsOncology supportive careRoutine supportive careHealthcare resource utilizationOptimal supportive careImprovement of QoLTreatment of symptomsPatient-centered careEvidence-based therapeutic interventionsDifferent healthcare systemsUnplanned hospitalizationMost patientsSymptom supportOncology practiceSymptom distressClinical studiesPatient managementOral drugsSymptom monitoringPatient complianceTreatment efficacyA Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Somaiah N, Chawla SP, Block MS, Morris JC, Do K, Kim JW, Druta M, Sankhala KK, Hwu P, Jones RL, Gnjatic S, Kim-Schulze S, Tuballes K, Yishak M, Lu H, Yakovich A, Meulen J, Chen M, Kenney RT, Bohac C, Pollack SM. A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1. OncoImmunology 2020, 9: 1847846. PMID: 33312760, PMCID: PMC7714520, DOI: 10.1080/2162402x.2020.1847846.Peer-Reviewed Original ResearchConceptsNY-ESO-1Prime-boost vaccine regimenVaccine regimenImmune responseNY-ESO-1 immune responsesNY-ESO-1 antibodyNY-ESO-1 proteinToll-like receptor agonistsInjection site painOral metronomic cyclophosphamidePhase 1b studyRecombinant protein boostCommon adverse eventsDisease control ratePrime-boost vaccineT cell responsesDose-escalation designSoft tissue sarcomasLentiviral vectorsMetronomic cyclophosphamideAdverse eventsMetastatic diseaseOverall survivalProgressive diseaseStudy entry
2019
First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1
Somaiah N, Block MS, Kim JW, Shapiro GI, T. K, Hwu P, Eder J, Jones RL, Lu H, Meulen J, Bohac C, Chen M, Hsu FJ, Gnjatic S, Pollack SM. First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1. Clinical Cancer Research 2019, 25: 5808-5817. PMID: 31227504, DOI: 10.1158/1078-0432.ccr-19-1025.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsAdverse eventsDendritic cellsSarcoma patientsImmune responseCommon treatment-related adverse eventsNY-ESO-1 immune responsesNY-ESO-1-expressing tumorsSolid tumorsLimited tumor burdenDisease control rateInjection site reactionsNY-ESO-1Potential clinical activityFavorable safety profileAntigen-specific responsesCancer-testis antigensAnti-NYDose cohortsPartial responseAdvanced cancerTumor burdenSafety profileSynovial sarcomaControl rateDissecting alterations in human CD8+ T cells with aging by high-dimensional single cell mass cytometry
Shin MS, Yim K, Moon K, Park HJ, Mohanty S, Kim JW, Montgomery RR, Shaw AC, Krishnaswamy S, Kang I. Dissecting alterations in human CD8+ T cells with aging by high-dimensional single cell mass cytometry. Clinical Immunology 2019, 200: 24-30. PMID: 30659916, PMCID: PMC6443094, DOI: 10.1016/j.clim.2019.01.005.Peer-Reviewed Original ResearchFirst-in-Human Phase I Trial of a Tumor-Targeted Cytokine (NHS-IL12) in Subjects with Metastatic Solid Tumors
Strauss J, Heery CR, Kim JW, Jochems C, Donahue RN, Montgomery AS, McMahon S, Lamping E, Marté J, Madan RA, Bilusic M, Silver MR, Bertotti E, Schlom J, Gulley JL. First-in-Human Phase I Trial of a Tumor-Targeted Cytokine (NHS-IL12) in Subjects with Metastatic Solid Tumors. Clinical Cancer Research 2019, 25: 99-109. PMID: 30131389, PMCID: PMC6320276, DOI: 10.1158/1078-0432.ccr-18-1512.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedCell Line, TumorDNA FragmentationDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunoglobulin GInfluenza, HumanInterleukin-12Killer Cells, NaturalLymphocytes, Tumor-InfiltratingMaleMaximum Tolerated DoseMiddle AgedNatural Killer T-CellsNeoplasmsNeoplasms, Second PrimaryReceptors, Antigen, T-CellRecombinant Fusion ProteinsTransaminasesConceptsTreatment-related adverse eventsAscending dose cohortsNHS-IL12Solid tumorsT-cell receptor sequencing analysisHuman phase I trialMultiple ascending dose cohortsSingle ascending dose (SAD) cohortsTumor-infiltrating lymphocyte densityPeripheral blood mononuclear cellsPeripheral immune cell subsetsDurable stable diseaseImmune checkpoint inhibitorsObjective tumor responsePhase II doseT-cell receptor diversityAdvanced solid tumorsFlu-like symptomsMetastatic solid tumorsPhase I trialNatural killer cellsImmune cell subsetsBlood mononuclear cellsWarrants further studyEnhanced antitumor activity
2018
CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer
Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. Journal Of Clinical Oncology 2018, 36: 2836-2844. PMID: 30110194, PMCID: PMC6161834, DOI: 10.1200/jco.2017.76.6212.Peer-Reviewed Original ResearchConceptsObjective response rateGastroesophageal junction cancerEsophagogastric cancerJunction cancerOverall survivalTreatment-related grade 3/4 adverse eventsInvestigator-assessed objective response rateResponse rateGrade 3/4 adverse eventsProgression-free survival ratesEfficacy of nivolumabLong-term OSMeaningful antitumor activityMetastatic esophagogastric cancerMore prior therapiesNivolumab Plus IpilimumabSafety of nivolumabManageable safety profilePrimary end pointSecond-line chemotherapySuperior overall survivalPhase III studyAssociation of tumorPrior therapyData cutoffAtezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study
Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fassò M, O’Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncology 2018, 4: 537-544. PMID: 29423515, PMCID: PMC5885219, DOI: 10.1001/jamaoncol.2017.5440.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Transitional CellCohort StudiesDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisSurvival AnalysisTime FactorsUrinary Bladder NeoplasmsUrotheliumConceptsDeath ligand 1 (PD-L1) expressionMedian overall survivalMetastatic urothelial carcinomaLigand 1 expressionProgression-free survivalPhase 1 studyOverall survivalAdverse eventsClinical benefitUrothelial carcinomaImmune cellsEastern Cooperative Oncology Group performance status 0Long-term clinical profilesMedian progression-free survivalSerious related adverse eventsSolid Tumors version 1.1Treatment-related adverse eventsLong-term clinical outcomesTumor-infiltrating immune cellsPerformance status 0Treatment-related deathsUnacceptable toxic effectsMetastatic urothelial cancerObjective response rateThird-line therapy
2017
Immune Analysis of Radium-223 in Patients With Metastatic Prostate Cancer
Kim JW, Shin MS, Kang Y, Kang I, Petrylak DP. Immune Analysis of Radium-223 in Patients With Metastatic Prostate Cancer. Clinical Genitourinary Cancer 2017, 16: e469-e476. PMID: 29137877, PMCID: PMC5878980, DOI: 10.1016/j.clgc.2017.10.010.Peer-Reviewed Original ResearchConceptsCell death protein 1Death protein 1Metastatic prostate cancerT cellsProstate cancerPeripheral blood mononuclear cellsFrequency of CD27Frequency of CD8Immune checkpoint moleculesT cell subsetsBlood mononuclear cellsProtein 1Peripheral blood samplesImmune deficiency conditionsSignificant changesMean frequencyEM CD8Checkpoint moleculesFirst doseMemory CD8Osteoblastic metastasesRadium-223Cell subsetsCytokine productionMononuclear cellsPerspectives in immunotherapy: meeting report from the “Immunotherapy Bridge”, Napoli, November 30th 2016
Ascierto PA, Daniele B, Hammers H, Hirsh V, Kim J, Licitra L, Nanda R, Pignata S. Perspectives in immunotherapy: meeting report from the “Immunotherapy Bridge”, Napoli, November 30th 2016. Journal Of Translational Medicine 2017, 15: 205. PMID: 29020960, PMCID: PMC5637331, DOI: 10.1186/s12967-017-1309-2.Peer-Reviewed Original ResearchConceptsTypes of cancerAnti-PD-1/PD-L1 monotherapyPlatinum-refractory metastatic urothelial carcinomaResponse rateImmune systemPD-L1/PDFirst-line monotherapyImmunotherapy-responsive diseasePD-L1 monotherapyPre-treated NSCLCAddition of chemotherapyDiscontinuation of therapyMetastatic urothelial carcinomaMetastatic breast cancerUse of nivolumabMetastatic renal carcinomaImmune checkpoint receptorsModest response ratesHigh response rateLess side effectsMultiple oncogenic pathwaysImmunotherapy BridgeLine monotherapyAdvanced NSCLCMetastatic NSCLC
2016
Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial
Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. The Lancet Oncology 2016, 17: 1590-1598. PMID: 27733243, PMCID: PMC5648054, DOI: 10.1016/s1470-2045(16)30496-x.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaTreatment-related adverse eventsAdvanced urothelial carcinomaSerious adverse eventsPlatinum-based chemotherapyUrothelial carcinomaAdverse eventsNivolumab monotherapyObjective responseInvestigator-assessed objective responsePrevious platinum-based chemotherapyProtocol-defined reasonsSafety of nivolumabManageable safety profileOpen-label studyPD-L1 expressionDurable clinical responsesDose of treatmentBristol-Myers SquibbCheckMate 032Data cutoffElevated lipaseMonotherapy groupPrimary endpointStudy drug