2022
Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy
Korenblik R, Olij B, Aldrighetti LA, Hilal MA, Ahle M, Arslan B, van Baardewijk LJ, Baclija I, Bent C, Bertrand CL, Björnsson B, de Boer MT, de Boer SW, Bokkers RPH, Rinkes IHMB, Breitenstein S, Bruijnen RCG, Bruners P, Büchler MW, Camacho JC, Cappelli A, Carling U, Chan BKY, Chang DH, choi J, Font JC, Crawford M, Croagh D, Cugat E, Davis R, De Boo DW, De Cobelli F, De Wispelaere JF, van Delden OM, Delle M, Detry O, Díaz-Nieto R, Dili A, Erdmann JI, Fisher O, Fondevila C, Fretland Å, Borobia FG, Gelabert A, Gérard L, Giuliante F, Gobardhan PD, Gómez F, Grünberger T, Grünhagen DJ, Guitart J, Hagendoorn J, Heil J, Heise D, Herrero E, Hess GF, Hoffmann MH, Iezzi R, Imani F, Nguyen J, Jovine E, Kalff JC, Kazemier G, Kingham TP, Kleeff J, Kollmar O, Leclercq WKG, Ben SL, Lucidi V, MacDonald A, Madoff DC, Manekeller S, Martel G, Mehrabi A, Mehrzad H, Meijerink MR, Menon K, Metrakos P, Meyer C, Moelker A, Modi S, Montanari N, Navines J, Neumann UP, Peddu P, Primrose JN, Qu X, Raptis D, Ratti F, Ridouani F, Rogan C, Ronellenfitsch U, Ryan S, Sallemi C, Moragues JS, Sandström P, Sarriá L, Schnitzbauer A, Serenari M, Serrablo A, Smits MLJ, Sparrelid E, Spüntrup E, Stavrou GA, Sutcliffe RP, Tancredi I, Tasse JC, Udupa V, Valenti D, Fundora Y, Vogl TJ, Wang X, White SA, Wohlgemuth WA, Yu D, Zijlstra IAJ, Binkert CA, Bemelmans MHA, van der Leij C, Schadde E, van Dam RM. Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy. CardioVascular And Interventional Radiology 2022, 45: 1391-1398. PMID: 35790566, PMCID: PMC9458562, DOI: 10.1007/s00270-022-03176-1.Peer-Reviewed Original ResearchConceptsFuture liver remnant hypertrophyHepatic vein embolizationMulticenter prospective single-arm trialResectable colorectal cancer liver metastasesColorectal cancer liver metastasesProspective single-arm trialFeasibility of resectionCancer liver metastasesDisease-free survivalSingle-arm trialSmall FLRPrimary endpointSecondary endpointsFLR hypertrophyLiver metastasesOverall survivalProspective trialVein embolizationLiver functionSafety profileArm trialLiver volumeWeek 1Week 3Study centersRandomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment
Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. CardioVascular And Interventional Radiology 2022, 45: 405-412. PMID: 35119481, PMCID: PMC8940827, DOI: 10.1007/s00270-021-03031-9.Peer-Reviewed Original ResearchConceptsBlinded independent central reviewIntermediate-stage hepatocellular carcinomaDisease control rateObjective response rateProgression-free survivalDuration of responseHepatocellular carcinomaCurative treatmentRECIST 1.1Primary endpointClinical benefitControl rateEastern Cooperative Oncology Group performance status 0Response rateChild-Pugh class ARandomized phase 3 studyDual primary endpointsOverall survival eventsPerformance status 0Previous systemic treatmentPD-1 inhibitorsPortal vein thrombosisPhase 3 studyResponse Evaluation CriteriaSolid Tumors 1.1
2020
Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE)
Callstrom MR, Woodrum DA, Nichols FC, Palussiere J, Buy X, Suh RD, Abtin FG, Pua BB, Madoff DC, Bagla SL, Papadouris DC, Fernando HC, Dupuy DE, Healey TT, Moore WH, Bilfinger TV, Solomon SB, Yarmohammadi H, Krebs HJ, Fulp CJ, Hakime A, Tselikas L, de Baere T. Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE). Journal Of Thoracic Oncology 2020, 15: 1200-1209. PMID: 32151777, PMCID: PMC9201766, DOI: 10.1016/j.jtho.2020.02.022.Peer-Reviewed Original ResearchMeSH KeywordsCryosurgeryHumansKidney NeoplasmsLung NeoplasmsNeoplasm Recurrence, LocalProspective StudiesQuality of LifeRetrospective StudiesTreatment OutcomeConceptsOverall survival ratePulmonary metastasesPercutaneous cryoablationSurvival rateLocal recurrence-free survivalGrade 4 eventsPleural catheter placementMetastatic lung tumorsPhase 2 studyKaplan-Meier methodRecurrence-free survivalRate of pneumothoraxKaplan-Meier estimatesKey inclusion criteriaQuality of lifeComplication eventsExtrapulmonary cancersMetastatic diseasePerformance statusInitial treatmentRecurrent tumorsCatheter placementLung metastasesMulticenter studyCryoablation treatment
2017
Multicenter Trial of the VenaTech Convertible Vena Cava Filter
Hohenwalter EJ, Stone JR, O’Moore P, Smith SJ, Selby JB, Lewandowski RJ, Samuels S, Kiproff PM, Trost DW, Madoff DC, Handel J, Gandras EJ, Vlahos A, Rilling WS. Multicenter Trial of the VenaTech Convertible Vena Cava Filter. Journal Of Vascular And Interventional Radiology 2017, 28: 1353-1362. PMID: 28821379, DOI: 10.1016/j.jvir.2017.06.032.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesProsthesis DesignPulmonary EmbolismTreatment OutcomeVena Cava FiltersVenous ThromboembolismConceptsVena cava filtersCava filtersDevice-related adverse eventsHigh-risk traumaAdverse event ratesSingle-arm studyFailure of anticoagulationTechnical success rateLong-term safetyConverted patientsAdverse eventsPulmonary embolismSurgical prophylaxisVenous thromboembolismMulticenter trialCaval filtersRight atriumSurgical removalClinical assessmentProcedure timePatientsEvent ratesMean timeSuccess rateMonths
2008
Chemotherapy With Bevacizumab Does Not Affect Liver Regeneration After Portal Vein Embolization in the Treatment of Colorectal Liver Metastases
Zorzi D, Chun YS, Madoff DC, Abdalla EK, Vauthey JN. Chemotherapy With Bevacizumab Does Not Affect Liver Regeneration After Portal Vein Embolization in the Treatment of Colorectal Liver Metastases. Annals Of Surgical Oncology 2008, 15: 2765. PMID: 18636296, PMCID: PMC5901734, DOI: 10.1245/s10434-008-0035-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsEmbolization, TherapeuticFemaleFollow-Up StudiesHumansLiver NeoplasmsLiver RegenerationMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinPortal VeinPrognosisProspective StudiesSurvival RateTreatment OutcomeConceptsPortal vein embolizationColorectal liver metastasesVascular endothelial growth factorLiver metastasesLiver regenerationPreoperative chemotherapyFLR hypertrophyLiver resectionVein embolizationFuture liver remnant volumeFLR volume increaseMajor liver resectionLiver remnant volumeEffect of chemotherapyImpairs liver regenerationEndothelial growth factorConclusionPreoperative chemotherapyConcurrent bevacizumabProspective databaseRight hepatectomyPostoperative outcomesConsecutive patientsRemnant volumeBevacizumabMurine model
2007
Pilot study of regional, hepatic intra‐arterial paclitaxel in patients with breast carcinoma metastatic to the liver
Camacho LH, Kurzrock R, Cheung A, Barber DF, Gupta S, Madoff DC, Wallace MJ, Kim EE, Curley SA, Hortobagyi GN, Mavligit G. Pilot study of regional, hepatic intra‐arterial paclitaxel in patients with breast carcinoma metastatic to the liver. Cancer 2007, 109: 2190-2196. PMID: 17464952, DOI: 10.1002/cncr.22672.Peer-Reviewed Original ResearchConceptsDominant liver metastasisBreast carcinomaTaxane exposureLiver metastasesAntitumor activityCommon treatment-related toxicitiesHepatic intra-arterial therapyPatient underwent liver resectionCourses of paclitaxelUnderwent liver resectionMean patient ageTreatment-related toxicityHepatic arterial infusionIntra-arterial therapyProcedure-related complicationsBreast carcinoma metastaticMetastatic breast carcinomaIntra-arterial catheterPercutaneous transfemoral approachTime of treatmentHepatic infusionStable diseaseCarcinoma metastaticPaclitaxel therapyTaxane therapy