2020
Randomized Phase II Trial of Carboplatin–Paclitaxel Compared with Carboplatin–Paclitaxel–Trastuzumab in Advanced (Stage III–IV) or Recurrent Uterine Serous Carcinomas that Overexpress Her2/Neu (NCT01367002): Updated Overall Survival Analysis
Fader AN, Roque DM, Siegel E, Buza N, Hui P, Abdelghany O, Chambers S, Secord AA, Havrilesky L, O'Malley DM, Backes FJ, Nevadunsky N, Edraki B, Pikaart D, Lowery W, ElSahwi K, Celano P, Bellone S, Azodi M, Litkouhi B, Ratner E, Silasi DA, Schwartz PE, Santin AD. Randomized Phase II Trial of Carboplatin–Paclitaxel Compared with Carboplatin–Paclitaxel–Trastuzumab in Advanced (Stage III–IV) or Recurrent Uterine Serous Carcinomas that Overexpress Her2/Neu (NCT01367002): Updated Overall Survival Analysis. Clinical Cancer Research 2020, 26: 3928-3935. PMID: 32601075, PMCID: PMC8792803, DOI: 10.1158/1078-0432.ccr-20-0953.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinChemotherapy, AdjuvantCystadenocarcinoma, SerousCytoreduction Surgical ProceduresDrug Administration ScheduleEndometrial NeoplasmsEndometriumFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelProgression-Free SurvivalReceptor, ErbB-2Survival AnalysisTrastuzumabConceptsProgression-free survivalRandomized phase II trialPhase II trialOverall survivalHER2/neuStage IIICarboplatin-paclitaxelII trialRecurrent diseaseControl armSurvival analysisRecurrent uterine serous carcinomaCarboplatin/paclitaxelUterine serous carcinomaOverall survival analysisEvaluable patientsEligible patientsPrimary endpointSecondary endpointsEndometrial cancerAggressive variantSerous carcinomaPrimary treatmentSurvival medianPatients
2018
Impact of carboplatin hypersensitivity and desensitization on patients with recurrent ovarian cancer
Altwerger G, Florsheim EB, Menderes G, Black J, Schwab C, Gressel GM, Nelson WK, Carusillo N, Passante T, Huang G, Litkouhi B, Azodi M, Silasi DA, Santin A, Schwartz PE, Ratner ES. Impact of carboplatin hypersensitivity and desensitization on patients with recurrent ovarian cancer. Journal Of Cancer Research And Clinical Oncology 2018, 144: 2449-2456. PMID: 30255380, DOI: 10.1007/s00432-018-2753-y.Peer-Reviewed Original ResearchConceptsCarboplatin hypersensitivityCarboplatin desensitizationHypersensitive patientsOverall survivalRisk factorsOvarian cancerTwo-sided Fisher exactAdvanced stage ovarian cancerInfusion of carboplatinRecurrent ovarian cancerIndependent risk factorLonger overall survivalStage ovarian cancerOvarian cancer patientsLong-term treatmentNew risk factorsHigher likelihoodTwo-sided p valueT-testStudent's t-testDesignRetrospective studyGermline BRCA1/2Improved OSLonger OSDesensitization protocolRandomized Phase II Trial of Carboplatin-Paclitaxel Versus Carboplatin-Paclitaxel-Trastuzumab in Uterine Serous Carcinomas That Overexpress Human Epidermal Growth Factor Receptor 2/neu.
Fader AN, Roque DM, Siegel E, Buza N, Hui P, Abdelghany O, Chambers SK, Secord AA, Havrilesky L, O'Malley DM, Backes F, Nevadunsky N, Edraki B, Pikaart D, Lowery W, ElSahwi KS, Celano P, Bellone S, Azodi M, Litkouhi B, Ratner E, Silasi DA, Schwartz PE, Santin AD. Randomized Phase II Trial of Carboplatin-Paclitaxel Versus Carboplatin-Paclitaxel-Trastuzumab in Uterine Serous Carcinomas That Overexpress Human Epidermal Growth Factor Receptor 2/neu. Journal Of Clinical Oncology 2018, 36: 2044-2051. PMID: 29584549, DOI: 10.1200/jco.2017.76.5966.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptor 2Progression-free survivalUterine serous carcinomaRecurrent uterine serous carcinomaMedian progression-free survivalRandomized phase II trialEpidermal growth factor receptor 2Phase II trialGrowth factor receptor 2Serous carcinomaHER2/neuFactor receptor 2II trialTreatment armsReceptor 2Stage IIIHER2/neu-positive diseaseOne-sided log-rank testMethods Eligible patientsPrimary end pointPrimary stage IIIUnexpected safety signalsLog-rank testHumanized monoclonal antibodyEligible patients
2016
Polymerase ε (POLE) ultra-mutation in uterine tumors correlates with T lymphocyte infiltration and increased resistance to platinum-based chemotherapy in vitro
Bellone S, Bignotti E, Lonardi S, Ferrari F, Centritto F, Masserdotti A, Pettinella F, Black J, Menderes G, Altwerger G, Hui P, Lopez S, de Haydu C, Bonazzoli E, Predolini F, Zammataro L, Cocco E, Ferrari F, Ravaggi A, Romani C, Facchetti F, Sartori E, Odicino FE, Silasi DA, Litkouhi B, Ratner E, Azodi M, Schwartz PE, Santin AD. Polymerase ε (POLE) ultra-mutation in uterine tumors correlates with T lymphocyte infiltration and increased resistance to platinum-based chemotherapy in vitro. Gynecologic Oncology 2016, 144: 146-152. PMID: 27894751, PMCID: PMC5183545, DOI: 10.1016/j.ygyno.2016.11.023.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsCarboplatinCarcinomaCD4 Lymphocyte CountCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCell SurvivalDisease-Free SurvivalDNA Polymerase IIDrug Resistance, NeoplasmEndometrial NeoplasmsFemaleHumansMicrosatellite InstabilityMiddle AgedMutationPoly-ADP-Ribose Binding ProteinsTumor Cells, CulturedConceptsBetter prognosisTumor cell linesInfiltration of CD4Number of CD4Platinum-based chemotherapyT lymphocyte infiltrationPD-1 receptorCell linesLow metastatic capabilityPOLE-mutated tumorsWild-type ECsEC cell linesLymphocyte infiltrationFavorable prognosisPD-1EC patientsType tumorsEnhanced immunogenicityT lymphocytesMolecular subtypesTumors correlatesChemotherapyMetastatic capabilityPrognosisTumorsPlatinum desensitization in patients with carboplatin hypersensitivity: A single-institution retrospective study
Altwerger G, Gressel GM, English DP, Nelson WK, Carusillo N, Silasi DA, Azodi M, Santin A, Schwartz PE, Ratner ES. Platinum desensitization in patients with carboplatin hypersensitivity: A single-institution retrospective study. Gynecologic Oncology 2016, 144: 77-82. PMID: 27789084, DOI: 10.1016/j.ygyno.2016.09.027.Peer-Reviewed Original ResearchConceptsPositive skin testsHypersensitivity reactionsDesensitization protocolSkin testCarboplatin infusionLife-threatening hypersensitivity reactionSingle-institution retrospective studyCarboplatin desensitization protocolPrior hypersensitivity reactionMajority of patientsCarboplatin hypersensitivity reactionsCarboplatin hypersensitivityPulmonary hypertensionAdverse eventsRetrospective reviewRetrospective studyGynecologic cancerGrade 0Patient deathRisk factorsCardiac conditionsPatientsLarger studyInfusionAge
2014
Adjuvant Carboplatin, Paclitaxel, and Vaginal Cuff Brachytherapy for Stage III Endometrial Cancer: Analysis of Outcomes and Patterns of Recurrence Based on Pathologic Characteristics
Young MR, Higgins SA, Ratner E, Yu JB, Mani S, Silasi DA, Azodi M, Rutherford T, Schwartz PE, Damast S. Adjuvant Carboplatin, Paclitaxel, and Vaginal Cuff Brachytherapy for Stage III Endometrial Cancer: Analysis of Outcomes and Patterns of Recurrence Based on Pathologic Characteristics. International Journal Of Gynecological Cancer 2014, 25: 431. PMID: 25621409, PMCID: PMC5603450, DOI: 10.1097/igc.0000000000000376.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAgedAntineoplastic Combined Chemotherapy ProtocolsBrachytherapyCarboplatinChemoradiotherapy, AdjuvantDisease-Free SurvivalEndometrial NeoplasmsFemaleHumansHysterectomyLymph NodesLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelRetrospective StudiesSurvival RateTreatment FailureConceptsDisease-free survivalVaginal cuff brachytherapyStage III endometrial adenocarcinomaStage III endometrial cancerNode-negative diseaseOverall survivalAdjuvant chemotherapyEndometrial cancerEndometrial adenocarcinomaType IComprehensive surgical stagingLow-risk histologyNode-positive diseaseOutcomes of patientsHigh-risk histologyNode-positive ratePatterns of recurrenceAnalysis of outcomesType II diseaseAdjuvant carboplatinVaginal failuresSurgical stagingAdjuvant therapyNode negativeNode positive
2013
Class III β-tubulin overexpression within the tumor microenvironment is a prognostic biomarker for poor overall survival in ovarian cancer patients treated with neoadjuvant carboplatin/paclitaxel
Roque DM, Buza N, Glasgow M, Bellone S, Bortolomai I, Gasparrini S, Cocco E, Ratner E, Silasi DA, Azodi M, Rutherford TJ, Schwartz PE, Santin AD. Class III β-tubulin overexpression within the tumor microenvironment is a prognostic biomarker for poor overall survival in ovarian cancer patients treated with neoadjuvant carboplatin/paclitaxel. Clinical & Experimental Metastasis 2013, 31: 101-110. PMID: 24005572, PMCID: PMC3947146, DOI: 10.1007/s10585-013-9614-5.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinCystadenocarcinoma, SerousDrug Resistance, NeoplasmFemaleHumansImmunohistochemistryNeoadjuvant TherapyOvarian NeoplasmsPaclitaxelPrognosisReal-Time Polymerase Chain ReactionTubulinTumor MicroenvironmentUp-RegulationConceptsClass III β-tubulinIII β-tubulinClass III β-tubulin expressionNeoadjuvant chemotherapyPoor overall survivalOverall survivalΒ-tubulin expressionClass III β-tubulin overexpressionPrimary cytoreductionNeoadjuvant carboplatin/paclitaxelPoor median overall survivalTumor microenvironmentAdvanced ovarian carcinomaCarboplatin/paclitaxelMedian overall survivalOvarian cancer patientsCell linesCancer stem cellsNeoadjuvant carboplatinPrimary debulkingVitro chemosensitivityClinical outcomesPatient populationCancer patientsStromal expression
2012
Neoadjuvant chemotherapy (NACT) is an effective way of managing elderly women with advanced stage ovarian cancer (FIGO Stage IIIC and IV)
Glasgow MA, Yu H, Rutherford TJ, Azodi M, Silasi D, Santin AD, Schwartz PE. Neoadjuvant chemotherapy (NACT) is an effective way of managing elderly women with advanced stage ovarian cancer (FIGO Stage IIIC and IV). Journal Of Surgical Oncology 2012, 107: 195-200. PMID: 22648987, DOI: 10.1002/jso.23171.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Ovarian EpithelialChemotherapy, AdjuvantCohort StudiesDrug Administration ScheduleFemaleHumansNeoadjuvant TherapyNeoplasm StagingNeoplasms, Glandular and EpithelialOvarian NeoplasmsPaclitaxelRetrospective StudiesSurvival AnalysisTreatment OutcomeConceptsEpithelial ovarian cancerAdvanced stage ovarian cancerUpfront cytoreductive surgeryNeoadjuvant chemotherapyStage ovarian cancerCytoreductive surgeryOvarian cancerNACT patientsAge 70Stage IV epithelial ovarian cancerAdvanced epithelial ovarian cancerImproved progression-free survivalRetrospective cohort studyShorter ICU stayStage IV diseaseProgression-free survivalLess blood lossSmall bowel resectionOverall survival analysisICU staySame chemotherapyUpfront surgeryMacroscopic diseasePerioperative morbidityStage IIIC
2007
Carcinosarcoma of the ovary
SILASI D, ILLUZZI JL, KELLY MG, RUTHERFORD TJ, MOR G, AZODI M, SCHWARTZ PE. Carcinosarcoma of the ovary. International Journal Of Gynecological Cancer 2007, 18: 22-29. PMID: 17451459, DOI: 10.1111/j.1525-1438.2007.00948.x.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinosarcomaChemotherapy, AdjuvantCisplatinCombined Modality TherapyDisease-Free SurvivalFemaleHumansIfosfamideMiddle AgedOvarian NeoplasmsPaclitaxelRegistriesRetrospective StudiesSurvival RateTreatment OutcomeConceptsProgression-free intervalMedian progression-free intervalAdvanced stage diseaseMedian survivalOptimal cytoreductionOvarian carcinosarcomaStage diseaseTaxol groupEffective cytotoxic regimenFirst-line cisplatinFirst-line chemotherapyCombination of carboplatinEpithelial ovarian cancerCytotoxic regimenIfosfamide groupAdjuvant cisplatinEntire cohortMedical recordsOvarian cancerCytoreductionPatientsSurvival rateCarcinosarcomaCarboplatinCisplatinNeoadjuvant chemotherapy lessens surgical morbidity in advanced ovarian cancer and leads to improved survival in stage IV disease
Hou JY, Kelly MG, Yu H, McAlpine JN, Azodi M, Rutherford TJ, Schwartz PE. Neoadjuvant chemotherapy lessens surgical morbidity in advanced ovarian cancer and leads to improved survival in stage IV disease. Gynecologic Oncology 2007, 105: 211-217. PMID: 17239941, DOI: 10.1016/j.ygyno.2006.11.025.Peer-Reviewed Original ResearchConceptsProgression-free survivalExtra-abdominal diseasePeri-operative morbidityStage IV diseaseOverall survivalPDS groupNAC patientsAggressive surgeryNeoadjuvant chemotherapyNAC groupOvarian cancerAdjuvant platinum-based chemotherapyAdvanced epithelial ovarian cancerImproved progression-free survivalIntra-operative blood lossFurther aggressive surgeryUnits of transfusionAdvanced ovarian cancerShorter hospital stayPlatinum-based chemotherapyTreatment of choiceEpithelial ovarian cancerAdvanced EOCOptimal cytoreductionCytoreductive surgery
2006
Atypical presentations of carboplatin hypersensitivity reactions: Characterization and management in patients with gynecologic malignancies
McAlpine JN, Kelly MG, O'Malley DM, Azodi M, Coombe K, Schwartz PE, Rutherford TJ. Atypical presentations of carboplatin hypersensitivity reactions: Characterization and management in patients with gynecologic malignancies. Gynecologic Oncology 2006, 103: 288-292. PMID: 16647749, DOI: 10.1016/j.ygyno.2006.03.007.Peer-Reviewed Original ResearchMeSH KeywordsCarboplatinDesensitization, ImmunologicDrug HypersensitivityFemaleHumansRetrospective StudiesSkin TestsConceptsSkin testingPlatinum hypersensitivityAllergy symptomsCarboplatin cycleLife-threatening adverse eventsCarboplatin skin testingCarboplatin-treated patientsCycles/patientDuration of symptomsRetrospective chart reviewSystemic allergic reactionsCarboplatin hypersensitivity reactionsContinuation of treatmentNegative predictive valueAPH patientsChart reviewChemotherapeutic cyclesGynecologic malignanciesAdverse eventsAtypical presentationDose escalationMedian onsetHypersensitivity reactionsAllergic reactionsMedian number
2004
Patients with uterine papillary serous cancers may benefit from adjuvant platinum-based chemoradiation
Kelly MG, O'Malley D, Hui P, McAlpine J, Dziura J, Rutherford TJ, Azodi M, Chambers SK, Schwartz PE. Patients with uterine papillary serous cancers may benefit from adjuvant platinum-based chemoradiation. Gynecologic Oncology 2004, 95: 469-473. PMID: 15581948, DOI: 10.1016/j.ygyno.2004.08.030.Peer-Reviewed Original ResearchConceptsUterine papillary serous carcinomaStage IA patientsResidual uterine diseaseAdvanced stage uterine papillary serous carcinomaIA patientsUterine diseaseSerous cancerUterine papillary serous cancerComplete surgical stagingObstetrics stage IAPapillary serous cancerDifferent therapeutic optionsPapillary serous carcinomaPlatinum-based chemoradiationMore effective treatmentsLocoregional diseaseHysterectomy specimenStage IAStage IIIAStage IIICSurgical stagingExtrauterine metastasesSerous carcinomaTherapeutic optionsFallopian tube