2024
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
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. PMID: 39516558, 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 ratePatients
2023
In 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 chemotherapy
2022
Elimusertib (BAY1895344), a novel ATR inhibitor, demonstrates in vivo activity in ATRX mutated models of uterine leiomyosarcoma
Harold J, Bellone S, Manavella 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. Elimusertib (BAY1895344), a novel ATR inhibitor, demonstrates in vivo activity in ATRX mutated models of uterine leiomyosarcoma. Gynecologic Oncology 2022, 168: 157-165. PMID: 36442427, PMCID: PMC9797429, DOI: 10.1016/j.ygyno.2022.11.014.Peer-Reviewed Original ResearchConceptsPatient-derived xenograftsUterine leiomyosarcomaVivo activityVehicle control treatmentMedian overall survivalTumor volume differencesOral scheduleWestern blot analysisOverall survivalOral gavageAggressive malignancyPDX modelsClinical trialsSCID miceTumor measurementsULMS patientsSignificant growth inhibitionNovel ATR inhibitorTumor samplesSignificant toxicityWestern blotKinase inhibitorsATRX mutationsGene mutationsControl vehicle
2021
Clinicopathologic characteristics and oncologic outcomes in adenosarcoma of gynecologic sites
Li JY, Mutlu L, Tymon-Rosario J, Khadraoui W, Nagarkatti N, Hui P, Buza N, Lu L, Schwartz P, Menderes G. Clinicopathologic characteristics and oncologic outcomes in adenosarcoma of gynecologic sites. Gynecologic Oncology Reports 2021, 39: 100913. PMID: 35005157, PMCID: PMC8715286, DOI: 10.1016/j.gore.2021.100913.Peer-Reviewed Original ResearchRecurrence-free survivalEarly-stage diseaseHigh-grade histologyOvarian preservationNode dissectionGrade histologyOncologic outcomesOverall survivalClinicopathologic characteristicsMyometrial invasionSarcomatous overgrowthPatients underwent lymph node dissectionUnderwent lymph node dissectionCox proportional hazards regressionLymph node dissectionEvidence of diseaseNon-inferior outcomesDeep myometrial invasionProportional hazards regressionLog-rank testKaplan-Meier estimatesLarge patient cohortPractical management optionsBilateral adnexectomyCervical adenosarcomaA phase 2 evaluation of pembrolizumab for recurrent Lynch‐like versus sporadic endometrial cancers with microsatellite instability
Bellone S, Roque DM, Siegel ER, Buza N, Hui P, Bonazzoli E, Guglielmi A, Zammataro L, Nagarkatti N, Zaidi S, Lee J, Silasi D, Huang GS, Andikyan V, Damast S, Clark M, Azodi M, Schwartz PE, Tymon‐Rosario J, Harold JA, Mauricio D, Zeybek B, Menderes G, Altwerger G, Ratner E, Alexandrov LB, Iwasaki A, Kong Y, Song E, Dong W, Elvin JA, Choi J, Santin AD. A phase 2 evaluation of pembrolizumab for recurrent Lynch‐like versus sporadic endometrial cancers with microsatellite instability. Cancer 2021, 128: 1206-1218. PMID: 34875107, PMCID: PMC9465822, DOI: 10.1002/cncr.34025.Peer-Reviewed Original ResearchConceptsObjective response rateImmune checkpoint inhibitorsProgression-free survivalEndometrial cancerWhole-exome sequencingSporadic endometrial cancerOverall survivalEnd pointPhase 2 pilot studyPrimary end pointSecondary end pointsTumor mutation burdenPhase 2 evaluationLarger confirmatory studiesAntigen processing/presentationProcessing/presentationCheckpoint inhibitorsSurgical resectionICI resistanceDMMR patientsPrognostic significanceDMMR tumorsMechanisms of resistanceLocal treatmentSporadic MSIReproducibility of scoring criteria for HER2 immunohistochemistry in endometrial serous carcinoma: a multi-institutional interobserver agreement study
Buza N, Euscher ED, Matias-Guiu X, McHenry A, Oliva E, Ordulu Z, Parra-Herran C, Rottmann D, Turner BM, Wong S, Hui P. Reproducibility of scoring criteria for HER2 immunohistochemistry in endometrial serous carcinoma: a multi-institutional interobserver agreement study. Modern Pathology 2021, 34: 1194-1202. PMID: 33536574, DOI: 10.1038/s41379-021-00746-5.Peer-Reviewed Original ResearchConceptsEndometrial serous carcinomaHER2 scoring criteriaSerous carcinomaHER2 scoreGynecologic pathologistsAnti-human epidermal growth factor receptor 2 (HER2) therapyRecent successful clinical trialsInterobserver disagreementCombination of HER2Successful clinical trialsHER2 gene amplificationInterobserver agreement studyScoring criteriaInterobserver agreement ratesOverall survivalEndometrial cancerPathologic studiesHER2 statusClinical trialsGastric carcinomaHER2 testingHER2 immunohistochemistryAdvanced stageCarcinomaScoring system
2020
HER2 Testing and Reporting in Endometrial Serous Carcinoma: Practical Recommendations for HER2 Immunohistochemistry and Fluorescent In Situ Hybridization: Proceedings of the ISGyP Companion Society Session at the 2020 USCAP Annual Meeting
Buza N. HER2 Testing and Reporting in Endometrial Serous Carcinoma: Practical Recommendations for HER2 Immunohistochemistry and Fluorescent In Situ Hybridization: Proceedings of the ISGyP Companion Society Session at the 2020 USCAP Annual Meeting. International Journal Of Gynecological Pathology 2020, 40: 17-23. PMID: 33290351, DOI: 10.1097/pgp.0000000000000711.Peer-Reviewed Original ResearchConceptsEndometrial serous carcinomaSerous carcinomaHER2 testingClinical trialsISGyP Companion Society SessionHER2 testing algorithmStandard chemotherapy regimenAnti-HER2 therapyRecent clinical trialsNew patient cohortCurrent clinical practiceHER2 scoring criteriaHER2 protein expressionUSCAP Annual MeetingChemotherapy regimenOverall survivalAppropriate triagingClinical benefitPatient cohortPatient enrollmentTrial criteriaTherapeutic responseTreatment approachesClinical practiceHER2 immunohistochemistryHuman epidermal growth factor 2 (HER2) in early stage uterine serous carcinoma: A multi-institutional cohort study
Erickson BK, Najjar O, Damast S, Blakaj A, Tymon-Rosario J, Shahi M, Santin A, Klein M, Dolan M, Cimino-Mathews A, Buza N, Ferriss JS, Stone RL, Khalifa M, Fader AN. Human epidermal growth factor 2 (HER2) in early stage uterine serous carcinoma: A multi-institutional cohort study. Gynecologic Oncology 2020, 159: 17-22. PMID: 32709539, PMCID: PMC7541557, DOI: 10.1016/j.ygyno.2020.07.016.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorChemoradiotherapy, AdjuvantCystadenocarcinoma, SerousFemaleFollow-Up StudiesHumansHysterectomyImmunohistochemistryMiddle AgedNeoplasm InvasivenessNeoplasm Recurrence, LocalNeoplasm StagingPrognosisProgression-Free SurvivalReceptor, ErbB-2Retrospective StudiesRisk AssessmentUnited StatesUterine NeoplasmsUterusConceptsHuman epidermal growth factor 2Uterine serous carcinomaHER2-positive tumorsEarly-stage diseaseOverall survivalSerous carcinomaCohort studyHER2 positivityPositive tumorsEarly stage uterine serous carcinomaLymph-vascular space invasionRecurrent uterine serous carcinomaMulti-institutional cohort studyHuman epidermal growth factor receptor 2Multi-center cohort studyEpidermal growth factor receptor 2Epidermal growth factor 2HER2-positive cohortGrowth factor receptor 2HER2-negative tumorsEquivocal IHC resultsFactor receptor 2Inferior PFSAdjuvant therapyGrowth factor 2Human epidermal growth factor 2 (HER2) in early stage uterine serous carcinoma: A multi-institutional cohort.
Erickson B, Najjar O, Klein M, Shahi M, Dolan M, Cimino-Mathews A, Grandelis A, Buza N, Delaney P, Tymon-Rosario J, Santin A, Ferriss J, Stone R, Nickles Fader A. Human epidermal growth factor 2 (HER2) in early stage uterine serous carcinoma: A multi-institutional cohort. Journal Of Clinical Oncology 2020, 38: 6084-6084. DOI: 10.1200/jco.2020.38.15_suppl.6084.Peer-Reviewed Original ResearchHuman epidermal growth factor 2Uterine serous carcinomaEarly stage uterine serous carcinomaEarly-stage diseaseMulti-institutional cohortHER2-positive tumorsSerous carcinomaOverall survivalHER2 overexpressionStage ILymph-vascular space invasionHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Epidermal growth factor 2Endometrial cancer deathsHER2-positive cohortHER2-positive diseaseStage IB diseaseBreast cancer guidelinesGrowth factor receptor 2HER2-negative tumorsWorse survival outcomesKaplan-Meier analysisBody mass indexPoor prognostic tumor
2013
Class III beta-tubulin overexpression within the tumor microenvironment is a prognostic biomarker for poor overall survival in ovarian cancer patients treated with neoadjuvant carboplatin/paclitaxel
Roque D, Buza N, Glasgow M, Ratner E, Silasi D, Azodi M, Rutherford T, Schwartz P, Santin A. Class III beta-tubulin overexpression within the tumor microenvironment is a prognostic biomarker for poor overall survival in ovarian cancer patients treated with neoadjuvant carboplatin/paclitaxel. Gynecologic Oncology 2013, 130: e124-e125. DOI: 10.1016/j.ygyno.2013.04.358.Peer-Reviewed Original Research