2024
Randomized phase II trial of weekly ixabepilone with or without biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer: Updated survival and subgroup analyses
Roque D, Siegel E, Buza N, Bellone S, Huang G, Andikyan V, Clark M, Azodi M, Schwartz P, Rao G, Xu F, Hui P, Altwerger G, Ratner E, Santin A. Randomized phase II trial of weekly ixabepilone with or without biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer: Updated survival and subgroup analyses. Gynecologic Oncology 2024, 190: s299-s301. DOI: 10.1016/j.ygyno.2024.07.449.Peer-Reviewed Original ResearchDiagnostic experiences of Black and White patients with uterine cancer: A qualitative study
Britton M, Izampuye E, Clark M, Ornstein R, Nunez-Smith M, Wright J, Xu X. Diagnostic experiences of Black and White patients with uterine cancer: A qualitative study. Gynecologic Oncology 2024, 191: 67-73. PMID: 39362045, DOI: 10.1016/j.ygyno.2024.09.010.Peer-Reviewed Original ResearchDiagnosis of uterine cancerUterine cancerRacial disparitiesHealthcare systemSocial determinants of healthNon-Hispanic White (WhiteGynecologic careDeterminants of healthDiscriminatory experiencesSemi-structured interviewsPatient engagementSocial determinantsAcceptance of discomfortHealthcare accessPerceived barriersPatient experienceThematic analysisDiagnostic journeyQualitative studyAudio-recordedBlack respondentsWhite patientsNegative experiencesHealthcareStage II-IV diseaseTrastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody–drug conjugate, demonstrates in vitro and in vivo antitumor activity against primary and metastatic ovarian tumors overexpressing HER2
Mutlu L, McNamara B, Bellone S, Manavella D, Demirkiran C, Greenman M, Verzosa M, Buza N, Hui P, Hartwich T, Harold J, Yang-Hartwich Y, Zipponi M, Altwerger G, Ratner E, Huang G, Clark M, Andikyan V, Azodi M, Schwartz P, Santin A. Trastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody–drug conjugate, demonstrates in vitro and in vivo antitumor activity against primary and metastatic ovarian tumors overexpressing HER2. Clinical & Experimental Metastasis 2024, 41: 765-775. PMID: 38909139, DOI: 10.1007/s10585-024-10297-z.Peer-Reviewed Original ResearchHigh-grade serous ovarian cancerClear cell carcinomaHER2-targeting antibody-drug conjugateAntibody-drug conjugatesT-DXdReceptor over-expressionTrastuzumab deruxtecanXenograft modelCell linesOvarian clear cell carcinomaOvarian cancer cell linesTumors overexpressing HER2Biologically aggressive tumorsFluorescence in situ hybridization assaySerous ovarian cancerEffective antibody-drug conjugatesIn vivo antitumor activityMouse xenograft modelMetastatic cell linesDS-8201aCancer cell linesAggressive tumorsHER2 expressionCell carcinomaOvarian cancerRandomized phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer (NCT03093155): Updated survival and subgroup analyses
Roque D, Siegel E, Buza N, Bellone S, Huang G, Altwerger G, Andikyan V, Clark M, Azodi M, Schwartz P, Rao G, Ratner E, Santin A. Randomized phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer (NCT03093155): Updated survival and subgroup analyses. BJC Reports 2024, 2: 43. PMCID: PMC11523995, DOI: 10.1038/s44276-024-00067-5.Peer-Reviewed Original ResearchPre-treated ovarian cancerOverall survivalBev armsDose reductionOvarian cancerTaxane responseRandomized phase 2 trialRandomized phase II trialPaclitaxel-resistant diseaseResultsThirty-seven patientsTreated with paclitaxelPhase 2 trialBiweekly bevacizumabDays 1,8,15Taxane-sensitiveUpdate survivalProgression-freePeritoneal cancerDose modificationTaxane sensitivityPlatinum resistanceSubset analysisSubgroup analysisResponse ratePatientsRandomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147)
Sheth S, Oh J, Bellone S, Siegel E, Greenman M, Mutlu L, McNamara B, Pathy S, Clark M, Azodi M, Altwerger G, Andikyan V, Huang G, Ratner E, Kim D, Iwasaki A, Levi A, Buza N, Hui P, Flaherty S, Schwartz P, Santin A. Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147). Clinical Cancer Research 2024, 30: of1-of10. PMID: 38592381, DOI: 10.1158/1078-0432.ccr-23-3639.Peer-Reviewed Original ResearchConceptsRandomized phase II trialCD4/CD8 T cellsT cellsHPV clearanceArm BNo significant differenceClinical surveillanceRate of HPV clearanceSecondary outcomesPre-neoplastic cervical lesionsCervical intraepithelial neoplasiaT cell infiltrationT cell responsesSignificant differenceCIN3 patientsIntraepithelial neoplasiaArm ACervical lesionsImiquimod groupSurveillance armVaginal suppositoriesProspective trialsArm CHPV vaccinationImiquimodCorrection: Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer
Roque D, Siegel E, Buza N, Bellone S, Silasi D, Huang G, Andikyan V, Clark M, Azodi M, Schwartz P, Rao G, Reader J, Hui P, Tymon-Rosario J, Harold J, Mauricio D, Zeybek B, Menderes G, Altwerger G, Ratner E, Santin A. Correction: Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer. British Journal Of Cancer 2024, 130: 1073-1073. PMID: 38438590, PMCID: PMC10951353, DOI: 10.1038/s41416-024-02628-4.Peer-Reviewed Original Research
2023
Black-White differences in uterine cancer symptomatology and stage at diagnosis
Xu X, Chen L, Nunez-Smith M, Clark M, Ferris J, Hershman D, Wright J. Black-White differences in uterine cancer symptomatology and stage at diagnosis. Gynecologic Oncology 2023, 180: 118-125. PMID: 38091770, PMCID: PMC10922746, DOI: 10.1016/j.ygyno.2023.11.029.Peer-Reviewed Original ResearchAdvanced stage diagnosisWhite patientsPostmenopausal bleedingPatient characteristicsEnd Results-Medicare databaseBlack-white differencesBlack-White disparitiesBlack patientsUterine cancerCancer symptomsHigh riskPatientsAdvanced stageSymptomsDiagnosisCancer symptomatologyRegression modelsRiskLarge proportionBleedingHistologyCancerEpidemiologySymptomatologyMonthsICG Fluorescence Technique for Detection of Sentinel Lymph Nodes in Laparoscopic Endometrial Cancer Staging
AlAshqar A, Mutlu L, McNamara B, Harold J, Clark M, Huang G, Azodi M, Schwartz P, Santin A, Ratner E, Altwerger G, Andikyan V. ICG Fluorescence Technique for Detection of Sentinel Lymph Nodes in Laparoscopic Endometrial Cancer Staging. Journal Of Minimally Invasive Gynecology 2023, 30: s36. DOI: 10.1016/j.jmig.2023.08.110.Peer-Reviewed Original ResearchEndometrial cancer stagingSentinel lymph nodesLymph nodesCancer stagingSentinel lymph node identificationICG fluorescence techniqueTertiary care hospitalLymph node identificationICG techniqueSentinel lymphCare hospitalIntervention useStagingDye techniqueNode identificationLymphPatientsMalignancyHospitalTimeliness of diagnostic evaluation for postmenopausal bleeding: A retrospective cohort study using claims data
Xu X, Chen L, Nunez-Smith M, Clark M, Wright J. Timeliness of diagnostic evaluation for postmenopausal bleeding: A retrospective cohort study using claims data. PLOS ONE 2023, 18: e0289692. PMID: 37682914, PMCID: PMC10490884, DOI: 10.1371/journal.pone.0289692.Peer-Reviewed Original ResearchConceptsPostmenopausal bleedingFirst diagnostic procedureDiagnostic evaluationDiagnostic proceduresGynecologic conditionsMedicaid patientsCox proportional hazards modelPrompt diagnostic evaluationRetrospective cohort studyMarketScan Research DatabasesAdditional risk factorsNon-clinical factorsCommon gynecologic conditionProportional hazards modelLower ratesCohort studyMost patientsPatient characteristicsBenign etiologyGynecologic cancerCancer patientsPreventive careUterine cancerInsurance typeRisk factorsIn Vivo and In Vitro Efficacy of Trastuzumab Deruxtecan in Uterine Serous Carcinoma.
Mutlu L, Manavella D, Bellone S, McNamara B, Harold J, Mauricio D, Siegel E, Buza N, Hui P, Hartwich T, Yang-Hartwich Y, Demirkiran C, Verzosa M, Altwerger G, Ratner E, Huang G, Clark M, Andikyan V, Azodi M, Dottino P, Schwartz P, Santin A. In Vivo and In Vitro Efficacy of Trastuzumab Deruxtecan in Uterine Serous Carcinoma. Molecular Cancer Therapeutics 2023, 22: 1404-1412. PMID: 37676984, DOI: 10.1158/1535-7163.mct-23-0126.Peer-Reviewed Original ResearchConceptsUterine serous carcinomaAntibody-dependent cellular cytotoxicityT-DXdUSC patientsUSC cell linesTrastuzumab deruxtecanSerous carcinomaHER2 expressionClinical trialsRecurrent uterine serous carcinomaTopoisomerase I inhibitor payloadSignificant antibody-dependent cellular cytotoxicityCell linesMultiple tumor indicationsPrimary USC cell linesLow HER2 expressionFuture clinical trialsHigh recurrence ratePeripheral blood lymphocytesERBB2 gene amplificationGrowth suppressionHER2-overexpressing cell linesTumor growth suppressionOverall survivalStandard chemotherapyUterine Leiomyosarcomas harboring MAP2K4 gene amplification are markedly sensitive in vivo to PLX8725, a Novel MAP2K4 Inhibitor (1315)
McNamara B, Harold J, Manavella D, Bellone S, Mutlu L, Hartwich T, Zipponi M, Yang-Hartwich Y, Demirkiran C, Verzosa M, Choi J, Dong W, Buza N, Hui P, Altwerger G, Huang G, Andikyan V, Clark M, Ratner E, Azodi M, Schwartz P, Schlessinger J, Santin A. Uterine Leiomyosarcomas harboring MAP2K4 gene amplification are markedly sensitive in vivo to PLX8725, a Novel MAP2K4 Inhibitor (1315). Gynecologic Oncology 2023, 176: s193. DOI: 10.1016/j.ygyno.2023.06.218.Peer-Reviewed Original ResearchDelayed presentation of placenta accreta following a first‐trimester medical abortion
Maurer J, Ramani S, Xu B, Gallousis S, Clark M, Andikyan V. Delayed presentation of placenta accreta following a first‐trimester medical abortion. Clinical Case Reports 2023, 11: e7849. PMID: 37636882, PMCID: PMC10457480, DOI: 10.1002/ccr3.7849.Peer-Reviewed Original ResearchHyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer
Gelissen J, Adjei N, McNamara B, Mutlu L, Harold J, Clark M, Altwerger G, Dottino P, Huang G, Santin A, Azodi M, Ratner E, Schwartz P, Andikyan V. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. Annals Of Surgical Oncology 2023, 30: 5597-5609. PMID: 37358686, DOI: 10.1245/s10434-023-13757-0.Peer-Reviewed Original ResearchConceptsHyperthermic intraperitoneal chemotherapyIntraperitoneal chemotherapyOvarian cancerStage III epithelial ovarian cancerUse of HIPECEpithelial ovarian cancerHigh-quality evidenceOvarian cancer treatmentHIPEC useInterval cytoreductionCytoreductive surgeryNeoadjuvant chemotherapyPerioperative careHIPEC protocolsHIPEC techniqueTreatment modalitiesPatient outcomesSingle administrationTumor disseminationChemotherapyCancerCancer treatmentOptimal candidatesMain siteLife dataPreliminary results of a phase II trial with sacituzumab govitecan-hziy in patients with recurrent endometrial carcinoma overexpressing Trop-2.
Santin A, McNamara B, Siegel E, Harold J, Mutlu L, Altwerger G, Huang G, Andikyan V, Clark M, Ratner E, Azodi M, Dottino P, Schwartz P, Bellone S. Preliminary results of a phase II trial with sacituzumab govitecan-hziy in patients with recurrent endometrial carcinoma overexpressing Trop-2. Journal Of Clinical Oncology 2023, 41: 5599-5599. DOI: 10.1200/jco.2023.41.16_suppl.5599.Peer-Reviewed Original ResearchRecurrent endometrial carcinomaSacituzumab govitecan-hziyTrop-2 overexpressionPhase 2 trialEndometrial carcinomaUterine serous carcinomaTrop-2Endometrioid adenocarcinomaSerous carcinomaClinical activityMetastatic triple-negative breast cancerAnti-Trop-2 antibodyGrade 3 endometrioid adenocarcinomaTriple-negative breast cancerAdequate bone marrowUnexpected safety signalsMetastatic urothelial cancerClear cell histologyPhase II trialSystemic corticosteroid usePlatinum-based chemotherapyFavorable safety profileDurable disease controlRemarkable clinical activityStage 1Uterine leiomyosarcomas harboring MAP2K4 gene amplification are sensitive in vivo to PLX8725, a novel MAP2K4 inhibitor
McNamara B, Harold J, Manavella D, Bellone S, Mutlu L, Hartwich T, Zipponi M, Yang-Hartwich Y, Demirkiran C, Verzosa M, Yang K, Choi J, Dong W, Buza N, Hui P, Altwerger G, Huang G, Andikyan V, Clark M, Ratner E, Azodi M, Schwartz P, Burton E, Inagaki H, Albers A, Zhang C, Bollag G, Schlessinger J, Santin A. Uterine leiomyosarcomas harboring MAP2K4 gene amplification are sensitive in vivo to PLX8725, a novel MAP2K4 inhibitor. Gynecologic Oncology 2023, 172: 65-71. PMID: 36958197, PMCID: PMC10192120, DOI: 10.1016/j.ygyno.2023.03.009.Peer-Reviewed Original ResearchConceptsUterine leiomyosarcomaPDX modelsGain of functionMedian overall survivalPhase I trialOral gavage dailyVivo activityTumor growth inhibitionTumor volume differencesTumor cell proliferationOverall survivalTolerable toxicityI trialOral treatmentTreatment cohortsGavage dailyAggressive tumorsSCID miceULMS patientsPK studiesTumor samplesWestern blotCell proliferationControl vehicleLeiomyosarcomaCorrigendum to “Elimusertib (BAY1895344), a novel ATR inhibitor, demonstrates in vivo activity in ATRX mutated models of uterine leiomyosarcoma”
Harold J, Bellone S, Manavell D, Mutlu L, McNamara B, Hartwich T, Zipponi M, Yang-Hartwich Y, Demirkiran C, Verzosa M, Choi J, Dong W, Buza N, Hui P, Altwerger G, Huang G, Andikyan V, Clark M, Ratner E, Azodi M, Schwartz P, Santin A. Corrigendum to “Elimusertib (BAY1895344), a novel ATR inhibitor, demonstrates in vivo activity in ATRX mutated models of uterine leiomyosarcoma”. Gynecologic Oncology 2023, 170: 334. PMID: 36906375, PMCID: PMC10266020, DOI: 10.1016/j.ygyno.2023.01.029.Peer-Reviewed Original ResearchChanges to same day discharge after minimally invasive hysterectomy throughout COVID‐19 pandemic
Sullivan M, Michel L, Wasser T, Clark M, Chudnoff S, Andikyan V. Changes to same day discharge after minimally invasive hysterectomy throughout COVID‐19 pandemic. Journal Of Obstetrics And Gynaecology Research 2023, 49: 1418-1423. PMID: 36808793, DOI: 10.1111/jog.15617.Peer-Reviewed Original ResearchConceptsRate of SDDSame-day dischargeInvasive hysterectomyDay dischargeCOVID-19 pandemicRetrospective chart reviewEmergency department visitsNumber of readmissionsMultivariable logistic regressionSame dayCommon gynecologic proceduresChi-square testChart reviewED visitsDepartment visitsHospital admissionElective surgerySurgical complexityGynecologic proceduresInclusion criteriaNosocomial infectionsHysterectomyPatientsLogistic regressionHealthcare systemRacial disparities in diagnostic evaluation of uterine cancer among Medicaid beneficiaries
Xu X, Chen L, Nunez-Smith M, Clark M, Wright J. Racial disparities in diagnostic evaluation of uterine cancer among Medicaid beneficiaries. Journal Of The National Cancer Institute 2023, 115: 636-643. PMID: 36788453, PMCID: PMC10248843, DOI: 10.1093/jnci/djad027.Peer-Reviewed Original ResearchConceptsAbnormal uterine bleedingWhite patientsUterine cancerFirst diagnostic procedureDiagnostic evaluationBlack patientsDiagnostic proceduresBlack-White disparitiesManagement visitsMarketScan Multi-State Medicaid DatabaseMulti-State Medicaid DatabaseUterine bleedingPatient characteristicsMedicaid databaseEarly diagnosisMedicaid beneficiariesMultivariable regressionPatientsCancerRacial disparitiesDiagnosisVisitsMore evaluationDisparitiesBleedingThe Poly (ADP-ribose) polymerase inhibitor olaparib and pan-ErbB inhibitor neratinib are highly synergistic in HER2 overexpressing epithelial ovarian carcinoma in vitro and in vivo
Han C, McNamara B, Bellone S, Harold J, Manara P, Hartwich T, Mutlu L, Yang-Hartwich Y, Zipponi M, Demirkiran C, Verzosa M, Altwerger G, Ratner E, Huang G, Clark M, Andikyan V, Azodi M, Dottino P, Schwartz P, Santin A. The Poly (ADP-ribose) polymerase inhibitor olaparib and pan-ErbB inhibitor neratinib are highly synergistic in HER2 overexpressing epithelial ovarian carcinoma in vitro and in vivo. Gynecologic Oncology 2023, 170: 172-178. PMID: 36706643, PMCID: PMC10023457, DOI: 10.1016/j.ygyno.2023.01.015.Peer-Reviewed Original ResearchConceptsCombination of olaparibOvarian cancerHER2 expressionSingle agentCell linesGynecologic cancer mortalityHER2-negative tumorsOvarian cancer cell linesOvarian cancer patientsEpithelial ovarian carcinomaNovel therapeutic optionsOC cell linesUnmet medical needPoly (ADP-ribose) polymerase (PARP) inhibitorsPan-ErbB inhibitorSingle-agent olaparibPolymerase inhibitor olaparibPoly (ADP-ribose) polymerase (PARP) inhibitor olaparibPrimary HER2Cancer cell linesNegative tumorsTherapeutic optionsCancer mortalityCancer patientsNeu expressionTrastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody–drug conjugate with topoisomerase I inhibitor payload, shows antitumor activity in uterine and ovarian carcinosarcoma with HER2/neu expression
Mauricio D, Bellone S, Mutlu L, McNamara B, Manavella D, Demirkiran C, Verzosa M, Buza N, Hui P, Hartwich T, Harold J, Yang-Hartwich Y, Zipponi M, Altwerger G, Ratner E, Huang G, Clark M, Andikyan V, Azodi M, Schwartz P, Santin A. Trastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody–drug conjugate with topoisomerase I inhibitor payload, shows antitumor activity in uterine and ovarian carcinosarcoma with HER2/neu expression. Gynecologic Oncology 2023, 170: 38-45. PMID: 36610380, PMCID: PMC10445234, DOI: 10.1016/j.ygyno.2022.12.018.Peer-Reviewed Original ResearchConceptsHER2/neu expressionDS-8201aAntibody-drug conjugatesNeu expressionCS cell linesTrastuzumab deruxtecanOvarian carcinosarcomaTopoisomerase I inhibitor payloadCell linesAggressive gynecologic malignancyLimited therapeutic optionsEffective antibody-drug conjugatesCarcinosarcoma cell lineGynecologic malignanciesTherapeutic optionsIsotype controlSarcomatous elementsXenograft modelBystander killingFlow cytometryTumor cellsCarcinosarcomaAntitumor activityVivo studiesVivo activity