2022
Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients
Ortigoza MB, Yoon H, Goldfeld KS, Troxel AB, Daily JP, Wu Y, Li Y, Wu D, Cobb GF, Baptiste G, O’Keeffe M, Corpuz MO, Ostrosky-Zeichner L, Amin A, Zacharioudakis IM, Jayaweera DT, Wu Y, Philley JV, Devine MS, Desruisseaux MS, Santin AD, Anjan S, Mathew R, Patel B, Nigo M, Upadhyay R, Kupferman T, Dentino AN, Nanchal R, Merlo CA, Hager DN, Chandran K, Lai JR, Rivera J, Bikash CR, Lasso G, Hilbert TP, Paroder M, Asencio AA, Liu M, Petkova E, Bragat A, Shaker R, McPherson DD, Sacco RL, Keller MJ, Grudzen CR, Hochman JS, Pirofski LA, Rahman F, Ajayi A, Rodriguez S, Ledesma A, Keeling D, Rappoport N, Ebel S, Kim J, Chang M, Chan K, Patel P, Martocci A, Dave S, Darwish Y, Taveras M, Shoyelu V, Xin P, Iturrate E, Moldolsky L, Raimondo B, Mendez S, Hughes P, Sterling S, Lord A, Yaghi S, Veloso K, Sheikh M, Visconti-Ferrara E, Fleming A, Youn H, Jane Fran B, Medina R, McKell R, Khan S, Hamilton T, Sanchez C, Patel N, Cleare L, Vergnolle O, Nakouzi A, Quevedo G, Bortz R, Wirchnianski A, Florez C, Babb R, Ayala J, Tsagaris K, James A, Eke I, Obeidallah A, Sandu O, Sohval S, Serrano-Rahman L, Uehlinger J, Bartash R, Al-Abduladheem A, Gendlina I, Sheridan C, Bortnick A, Eichler J, Kaufman R, Yukelis S, Pennock M, Goggin M, Shen C, Annam J, Khokhar A, Barboto D, Lally B, Lee A, Lee M, Yang X, Allen S, Malaviya A, Moussa O, Park R, Sample R, Bae A, Benoni G, Boerger L, Baker L, Luther M, Ameti L, Briggs N, Golden M, Gormally M, Huang G, Johnson R, Morrison A, Montagna-Hill M, Rivera B, Cortezzo G, Debski K, Nicoletti, DeBenedictis K, Davis R, Marshall C, Duque Cuartas M, Beauchamps L, Bertran-Lopez J, Gonzales Zamora J, Delgado-Lelievre M, Dominguez S, Lee C, Kusack H, Karakeshishyan V, Hajaz A, Deniz D, Garcia G, Dae K, Blenet P, Jaffe D, Olson L, Sabogal D, Blust O, Del Prete Perez V, Bornia C, Rodriguez-Perez V, Calderon V, Ramdev R, Jolly A, Guzman I, Guerra R, Brito S, Hobbs R, Denham R, Dick J, Hernandez M, Nielsen L, Anjum S, Mader S, Stutz T, Mammadova M, Nichols P, Khan T, Boktour M, Castaneda B, Benitez B, Hinojosa E, Guerra B, Ortiz A, Hebbeler-Clark R, McShane P, Hibbard R, Hawkins B, Dohanich E, Wadle C, Greenlee K, Brooks J, Herrick C, Gode A, Bergl P, Hu K, Patel J, Srinivasan S, Graf J, Klis C, Reimer K, Carpenter E, Naczek C, Petersen R, Dex R, Drossart J, Zelten J, Brummitt C, Liang M, Yanny L, Dennison G, Runningen P, Brzezinski B, Fiebig S, Naczek C, Kasdorf M, Parameswaran L, Corcoran A, Rohatgi A, Wronska M, Wu X, Srinivasan R, Deng F, Filardo T, Pendse J, Blaser S, Whyte O, Gallagher J, Thomas O, Ramos D, Sturm-Reganato C, Fong C, Daus I, Payoen A, Chiofolo J, Friedman M, Wu D, Jacobson J, Schneider J, Sarwar U, Wang H, Huebinger R, Dronavalli G, Bai Y, Grimes C, Eldin K, Umana V, Martin J, Heath T, Bello F, Ransford D, Laurent-Rolle M, Shenoi S, Akide-Ndunge O, Thapa B, Peterson J, Knauf K, Patel S, Cheney L, Tormey C, Hendrickson J. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients. JAMA Internal Medicine 2022, 182: 115-126. PMID: 34901997, PMCID: PMC8669605, DOI: 10.1001/jamainternmed.2021.6850.Peer-Reviewed Original ResearchConceptsCCP recipientsPlacebo recipientsSecondary outcomesSymptom durationHospitalized patientsPrimary outcomeDay 28COVID-19SARS-CoV-2 serostatusSARS-CoV-2 titersWorld Health Organization (WHO) ordinal scaleCOVID-19 convalescent plasmaConvalescent plasma usePlacebo-controlled trialLess daysExploratory subgroup analysisNon-Hispanic blacksSARS-CoV-2CCP efficacyConcomitant medicationsAdverse eventsClinical improvementSymptom onsetConvalescent plasmaMedian age
2021
Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial
Bardia A, Messersmith WA, Kio EA, Berlin JD, Vahdat L, Masters GA, Moroose R, Santin AD, Kalinsky K, Picozzi V, O'Shaughnessy J, Gray JE, Komiya T, Lang JM, Chang JC, Starodub A, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Wegener WA, Goswami T, Ocean AJ. Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial. Annals Of Oncology 2021, 32: 746-756. PMID: 33741442, DOI: 10.1016/j.annonc.2021.03.005.Peer-Reviewed Original ResearchConceptsOverall safety populationAdverse eventsSacituzumab govitecanAntibody-drug conjugatesEpithelial cancersFebrile neutropeniaMost common treatment-related adverse eventsPhase I/II multicenter trialCommon treatment-related adverse eventsTreatment-related serious adverse eventsTrophoblast cell surface antigen 2Castrate-resistant prostate cancer patientsTreatment-related adverse eventsCastrate-resistant prostate cancerSmall cell lung cancerCell surface antigen 2Clinical benefit rateTreatment-related deathsObjective response rateSerious adverse eventsProgression-free survivalDuration of responseAdvanced epithelial cancersProstate cancer patientsSmall cell lung
2020
Modeling biological and genetic diversity in upper tract urothelial carcinoma with patient derived xenografts
Kim K, Hu W, Audenet F, Almassi N, Hanrahan AJ, Murray K, Bagrodia A, Wong N, Clinton TN, Dason S, Mohan V, Jebiwott S, Nagar K, Gao J, Penson A, Hughes C, Gordon B, Chen Z, Dong Y, Watson PA, Alvim R, Elzein A, Gao SP, Cocco E, Santin AD, Ostrovnaya I, Hsieh JJ, Sagi I, Pietzak EJ, Hakimi AA, Rosenberg JE, Iyer G, Vargas HA, Scaltriti M, Al-Ahmadie H, Solit DB, Coleman JA. Modeling biological and genetic diversity in upper tract urothelial carcinoma with patient derived xenografts. Nature Communications 2020, 11: 1975. PMID: 32332851, PMCID: PMC7181640, DOI: 10.1038/s41467-020-15885-7.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnimalsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiopsyCamptothecinCarcinoma, Transitional CellFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticGenetic VariationHigh-Throughput Nucleotide SequencingHumansImmunoconjugatesInterleukin Receptor Common gamma SubunitMaleMiceMice, Inbred NODMice, SCIDMiddle AgedMutationNeoplasm MetastasisNeoplasm TransplantationPhenotypePrecision MedicineProspective StudiesQuinolinesRetrospective StudiesSequence Analysis, RNATrastuzumabUrinary Bladder NeoplasmsUrotheliumConceptsUpper tract urothelial carcinomaUrothelial carcinomaCorresponding patient tumorsEstablishment of patientHigh genomic concordancePersonalized medicine strategiesHER2 kinase inhibitorDisease-specific modelsUTUC patientsCell line modelsPDX modelsBladder cancerTreatment paradigmGenomic concordanceInvasive tumorsSuperior efficacyPatient tumorsPatientsKinase inhibitorsAntibody drugsMedicine strategiesBiological heterogeneityCarcinomaXenograftsTumorsFirst-in-Human, Multicenter, Phase I Dose-Escalation and Expansion Study of Anti-Mesothelin Antibody–Drug Conjugate Anetumab Ravtansine in Advanced or Metastatic Solid Tumors
Hassan R, Blumenschein GR, Moore KN, Santin AD, Kindler HL, Nemunaitis JJ, Seward SM, Thomas A, Kim SK, Rajagopalan P, Walter AO, Laurent D, Childs BH, Sarapa N, Elbi C, Bendell JC. First-in-Human, Multicenter, Phase I Dose-Escalation and Expansion Study of Anti-Mesothelin Antibody–Drug Conjugate Anetumab Ravtansine in Advanced or Metastatic Solid Tumors. Journal Of Clinical Oncology 2020, 38: 1824-1835. PMID: 32213105, PMCID: PMC7255978, DOI: 10.1200/jco.19.02085.Peer-Reviewed Original ResearchConceptsAnetumab ravtansineDose-escalation cohortsMetastatic solid tumorsAnti-mesothelin antibodySolid tumorsExpansion cohortClinical activityCommon drug-related adverse eventsDrug-related adverse eventsPhase I Dose-EscalationMultiple solid tumor typesPhase IDose-expansion studyI Dose-EscalationPeripheral sensory neuropathyPhase II studyRecurrent ovarian cancerRecurrent solid tumorsPreliminary antitumor activityDrug-related deathsFavorable pharmacokinetic profileSolid tumor typesAntibody-drug conjugatesStable diseaseAdult patients
2019
Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study
Matulonis UA, Shapira-Frommer R, Santin AD, Lisyanskaya AS, Pignata S, Vergote I, Raspagliesi F, Sonke GS, Birrer M, Provencher DM, Sehouli J, Colombo N, González-Martín A, Oaknin A, Ottevanger PB, Rudaitis V, Katchar K, Wu H, Keefe S, Ruman J, Ledermann JA. Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study. Annals Of Oncology 2019, 30: 1080-1087. PMID: 31046082, DOI: 10.1093/annonc/mdz135.Peer-Reviewed Original ResearchConceptsRecurrent ovarian cancerObjective response rateDisease control rateProgression-free survivalTreatment-free intervalDuration of responseAdvanced recurrent ovarian cancerPD-L1 expressionPlatinum-free intervalCohort AOverall survivalPrior linesCohort BOvarian cancerHigh PD-L1 expressionLow objective response rateMedian DORSolid Tumors version 1.1End pointGynecologic cancer-related deathBlinded independent central reviewSafety of pembrolizumabSingle-agent pembrolizumabMedian overall survivalPhase II studySacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer
Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. New England Journal Of Medicine 2019, 380: 741-751. PMID: 30786188, DOI: 10.1056/nejmoa1814213.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnemiaAntibodies, Monoclonal, HumanizedAntigens, NeoplasmAntineoplastic AgentsCamptothecinCell Adhesion MoleculesDiarrheaDose-Response Relationship, DrugFemaleHumansImmunoconjugatesInfusions, IntravenousIrinotecanMaleMiddle AgedNeutropeniaProgression-Free SurvivalSurvival RateTriple Negative Breast NeoplasmsConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerSacituzumab govitecan-hziyProgression-free survivalClinical benefit rateIndependent central reviewBreast cancerResponse rateAdverse eventsOverall survivalCentral reviewBenefit rateHuman trophoblast cell surface antigen 2Refractory metastatic triple-negative breast cancerTrophoblast cell surface antigen 2Median progression-free survivalSN-38Shorter progression-free survivalCell surface antigen 2Blinded independent central reviewDurable objective responsesPrevious anticancer therapyUnacceptable toxic effectsObjective response rateMain adverse reactions
2011
A survey of gynecologic oncologists regarding the End-of-Life discussion: A pilot study
El-Sahwi KS, Illuzzi J, Varughese J, Carusillo N, Ratner ES, Silasi DA, Azodi M, Schwartz PE, Rutherford TJ, Santin AD. A survey of gynecologic oncologists regarding the End-of-Life discussion: A pilot study. Gynecologic Oncology 2011, 124: 471-473. PMID: 22014628, DOI: 10.1016/j.ygyno.2011.09.029.Peer-Reviewed Original ResearchConceptsWithdrawal of carePercent of respondentsGynecologic oncologistsLife discussionsAdvanced-stage cancerProgression of diseaseYears of ageFirst recurrenceMajor surgeryPatient ageHalf of respondentsStage cancerMedical statusResponse rateTumor sitePatientsOncologistsPilot studyPilot surveyHealth insuranceInitial responseSurvey MonkeyAgeSocial supportCare
2007
Advances in dendritic cell-based therapeutic vaccines for cervical cancer
Bellone S, Pecorelli S, Cannon MJ, Santin AD. Advances in dendritic cell-based therapeutic vaccines for cervical cancer. Expert Review Of Anticancer Therapy 2007, 7: 1473-1486. PMID: 17944571, DOI: 10.1586/14737140.7.10.1473.Peer-Reviewed Original ResearchMeSH KeywordsAdultAlphapapillomavirusAnimalsAntigen PresentationAntigens, ViralCancer VaccinesClinical Trials as TopicCombined Modality TherapyDendritic CellsDisease ProgressionDNA-Binding ProteinsFemaleHumansMaleMiceNeoplasmsOncogene Proteins, ViralPapillomavirus E7 ProteinsPapillomavirus InfectionsPeptide FragmentsRepressor ProteinsT-Lymphocyte SubsetsUterine Cervical NeoplasmsConceptsCervical cancerDendritic cellsMetastatic diseaseTherapeutic vaccinesDendritic cell-based therapeutic vaccineE7 oncoproteinsPowerful antigen-presenting cellsRecurrent/metastatic diseasePrimary T cell responsesAutologous dendritic cellsInvasive cervical cancerHuman papillomavirus infectionT cell responsesTherapeutic clinical trialsTumor-specific target antigensAntigen-presenting cellsImportant risk factorImportant health problemNovel therapeutic strategiesPapillomavirus infectionRadical surgeryCervical dysplasiaCancer deathRisk factorsClinical trialsLocal Administration of Interleukin-11 Ameliorates Intestinal Radiation Injury in Rats
Boerma M, Wang J, Burnett AF, Santin AD, Roman JJ, Hauer-Jensen M. Local Administration of Interleukin-11 Ameliorates Intestinal Radiation Injury in Rats. Cancer Research 2007, 67: 9501-9506. PMID: 17909060, DOI: 10.1158/0008-5472.can-07-0810.Peer-Reviewed Original ResearchConceptsIntestinal radiation injuryRadiation injuryRhIL-11Bowel loopsMucosal mast cell numbersIL-11Whole body radiation exposureRecombinant human IL-11Small bowel loopsED2-positive cellsRadiation injury scoreIntestinal wall thickeningMast cell numbersIntestinal radiation responseLocal administrationHuman IL-11Pelvic radiotherapySurgical transpositionIntraluminal administrationInjury scoreIntestinal loopsMale ratsSystemic administrationSevere toxicityDrug Administration