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
Randomized 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
2015
Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors
Abu-Khalaf MM, Baumgart MA, Gettinger SN, Doddamane I, Tuck DP, Hou S, Chen N, Sullivan C, Lezon-Geyda K, Zelterman D, Hatzis C, Deshpande H, Digiovanna MP, Azodi M, Schwartz PE, Harris LN. Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors. Cancer 2015, 121: 1817-1826. PMID: 25649370, DOI: 10.1002/cncr.29254.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityIntravenous nab-paclitaxelPhase 1b studyAdvanced solid tumorsNab-paclitaxelFDG activityDay 1Solid tumorsNanoparticle albumin-bound paclitaxelMammalian targetWeekly oral doseAcceptable safety profileRapamycin inhibitor sirolimusAlbumin-bound paclitaxelClinical trial endpointsExploratory gene expression analysisPositron emission tomographyStable diseaseTaxane therapyPartial responseWeekly doseComplete responseOral sirolimusPharmacodynamic assessmentOral dose
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 expressionPhenotypic modifications in ovarian cancer stem cells following Paclitaxel treatment
Craveiro V, Yang-Hartwich Y, Holmberg JC, Joo WD, Sumi NJ, Pizzonia J, Griffin B, Gill SK, Silasi DA, Azodi M, Rutherford T, Alvero AB, Mor G. Phenotypic modifications in ovarian cancer stem cells following Paclitaxel treatment. Cancer Medicine 2013, 2: 751-762. PMID: 24403249, PMCID: PMC3892380, DOI: 10.1002/cam4.115.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Agents, PhytogenicCarcinoma, Ovarian EpithelialDrug Resistance, NeoplasmFemaleHEK293 CellsHumansHyaluronan ReceptorsMiceMice, NudeMyeloid Differentiation Factor 88Neoplasms, Glandular and EpithelialNeoplastic Stem CellsOvarian NeoplasmsPaclitaxelPhenotypeRecurrenceSnail Family Transcription FactorsTranscription FactorsTumor BurdenXenograft Model Antitumor AssaysConceptsEpithelial ovarian cancerRecurrent epithelial ovarian cancerOvarian cancer stem cellsEOC stem cellsCancer stem cellsQuantitative polymerase chain reactionRecurrent diseaseOvarian cancerEOC cellsVivo ovarian cancer modelsStem cellsDoses of paclitaxelLethal gynecologic malignancyOvarian cancer modelProcess of recurrenceWestern blot analysisMaintenance therapyGynecologic malignanciesPrimary diseaseAggressive diseaseEOC patientsPrimary tumorPolymerase chain reactionAggressive phenotypePaclitaxel treatmentTubulin‐β‐III overexpression by uterine serous carcinomas is a marker for poor overall survival after platinum/taxane chemotherapy and sensitivity to epothilones
Roque DM, Bellone S, English DP, Buza N, Cocco E, Gasparrini S, Bortolomai I, Ratner E, Silasi D, Azodi M, Rutherford TJ, Schwartz PE, Santin AD. Tubulin‐β‐III overexpression by uterine serous carcinomas is a marker for poor overall survival after platinum/taxane chemotherapy and sensitivity to epothilones. Cancer 2013, 119: 2582-2592. PMID: 23585021, PMCID: PMC3700638, DOI: 10.1002/cncr.28017.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCystadenocarcinoma, SerousDrug Resistance, NeoplasmEpothilonesFemaleGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateMiddle AgedNeoplasm StagingPaclitaxelPlatinum CompoundsPredictive Value of TestsPrognosisReal-Time Polymerase Chain ReactionTubulinTubulin ModulatorsUp-RegulationUterine NeoplasmsConceptsUterine serous carcinomaOvarian serous carcinomaOverall survivalSerous carcinomaP-glycoproteinClinical outcomesPaclitaxel resistanceTreatment of USCPlatinum/taxane chemotherapyPoor overall survivalFresh frozen tissue samplesReal-time polymerase chain reactionCell linesTaxane chemotherapyEndometrial cancerPoor outcomePoor prognosisPolymerase chain reactionFresh frozen tissueMedian inhibitory concentrationClinical investigationSubset of individualsGlycoprotein expressionCarcinomaImmunohistochemistry
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
2011
Phase II Evaluation of Phenoxodiol in Combination With Cisplatin or Paclitaxel in Women With Platinum/Taxane-Refractory/Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
Kelly MG, Mor G, Husband A, O'Malley DM, Baker L, Azodi M, Schwartz PE, Rutherford TJ. Phase II Evaluation of Phenoxodiol in Combination With Cisplatin or Paclitaxel in Women With Platinum/Taxane-Refractory/Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers. International Journal Of Gynecological Cancer 2011, 21: 633-639. PMID: 21412168, DOI: 10.1097/igc.0b013e3182126f05.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialCisplatinDrug Resistance, NeoplasmFallopian Tube NeoplasmsFemaleHumansIsoflavonesMiddle AgedNeoplasms, Glandular and EpithelialOvarian NeoplasmsPaclitaxelPeritoneal NeoplasmsPlatinum CompoundsTaxoidsTreatment FailureTreatment OutcomeConceptsOverall best response rateBetter response rateOvarian cancerStable diseaseRefractory/Partial responseComplete responseDay 1Day 2Response ratePlatinum-resistant ovarian cancerGrade 4 toxicityTreatment-related deathsTreatment-related hospitalizationsPrimary peritoneal cancerPhase II evaluationResistant ovarian cancerCisplatin armEpithelial ovarianPaclitaxel armPaclitaxel weeklyPeritoneal cancerUnacceptable toxicityTreatment armsFallopian tube
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
MyD88 predicts chemoresistance to paclitaxel in epithelial ovarian cancer.
Silasi DA, Alvero AB, Illuzzi J, Kelly M, Chen R, Fu HH, Schwartz P, Rutherford T, Azodi M, Mor G. MyD88 predicts chemoresistance to paclitaxel in epithelial ovarian cancer. The Yale Journal Of Biology And Medicine 2006, 79: 153-63. PMID: 17940625, PMCID: PMC1994803.Peer-Reviewed Original ResearchConceptsOvarian cancer cellsEpithelial ovarian cancerExpression of MyD88Ovarian cancerOverall survivalCancer cellsMyD88 expressionRecurrent epithelial ovarian cancerShorter progression-free intervalOvarian malignant tumorsPositive ovarian cancer cellsProgression-free intervalTime of surgeryPaclitaxel combination chemotherapySpecific tumor markersPure cancer cellsCytotoxic agent paclitaxelPaclitaxel chemoresistanceWestern blot analysisPaclitaxel chemotherapyClinical courseCombination chemotherapyAppropriate therapyProinflammatory cytokinesPoor response