2023
Preliminary 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 1
2022
Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer
Roque DM, Siegel ER, Buza N, Bellone S, Silasi DA, Huang GS, Andikyan V, Clark M, Azodi M, Schwartz PE, Rao GG, Reader JC, Hui P, Tymon-Rosario JR, Harold J, Mauricio D, Zeybek B, Menderes G, Altwerger G, Ratner E, Santin AD. Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer. British Journal Of Cancer 2022, 126: 1695-1703. PMID: 35149854, PMCID: PMC8853032, DOI: 10.1038/s41416-022-01717-6.Peer-Reviewed Original ResearchConceptsPrimary peritoneal cancerPeritoneal cancerPredictive biomarkersDay 1Taxane-resistant ovarian cancerPhase II trialM2 days 1Bevacizumab 10Evaluable patientsPrior bevacizumabWeekly ixabepiloneII trialPrimary endpointSecondary endpointsRefractory statusTUBB3 expressionPrior receiptSubgroup analysisClinical trialsOvarian cancerIxabepilonePFSCancerBevacizumabPatients
2021
Trastuzumab tolerability in the treatment of advanced (stage III-IV) or recurrent uterine serous carcinomas that overexpress HER2/neu
Tymon-Rosario J, Siegel ER, Bellone S, Harold J, Adjei N, Zeybek B, Mauricio D, Altwerger G, Menderes G, Ratner E, Clark M, Andikyan V, Huang GS, Azodi M, Schwartz PE, Fader AN, Santin AD. Trastuzumab tolerability in the treatment of advanced (stage III-IV) or recurrent uterine serous carcinomas that overexpress HER2/neu. Gynecologic Oncology 2021, 163: 93-99. PMID: 34372971, PMCID: PMC8721852, DOI: 10.1016/j.ygyno.2021.07.033.Peer-Reviewed Original ResearchConceptsUterine serous carcinomaRecurrent uterine serous carcinomaAdverse eventsTreatment armsSerous carcinomaExperimental armToxicity profileTreatment-related adverse eventsTrastuzumab maintenance therapyCarboplatin/paclitaxelCardiac adverse eventsEndometrial cancer patientsGastrointestinal adverse eventsManageable toxicity profilePhase II trialEfficacy of trastuzumabSystem organ classII trialMaintenance therapyPrimary endpointSecondary endpointsMaintenance treatmentSafety profileCancer patientsCumulative toxicity
2011
Phase II trial of adjuvant pelvic radiation “sandwiched” between ifosfamide or ifosfamide plus cisplatin in women with uterine carcinosarcoma
Einstein MH, Klobocista M, Hou JY, Lee S, Mutyala S, Mehta K, Reimers LL, Kuo D, Huang GS, Goldberg GL. Phase II trial of adjuvant pelvic radiation “sandwiched” between ifosfamide or ifosfamide plus cisplatin in women with uterine carcinosarcoma. Gynecologic Oncology 2011, 124: 26-30. PMID: 22055846, PMCID: PMC3787514, DOI: 10.1016/j.ygyno.2011.10.008.Peer-Reviewed Original ResearchConceptsDisease-free survivalAddition of cisplatinUterine carcinosarcomaResidual diseasePelvic external beam radiotherapyYear disease-free survivalKaplan-Meier statistical methodAdjuvant pelvic radiationGrade 3/4 neutropeniaGross residual diseaseIfosfamide/cisplatinPhase II trialStage 1 patientsTolerable toxicity profileRare uterine tumorExternal beam radiotherapyAdjuvant settingEfficacious regimenGOG trialsPelvic radiationRecurrent carcinosarcomaMedian followSystemic chemotherapyII trialUterine tumorsPhase II trial of adjuvant pelvic radiation “sandwiched” between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma
Einstein MH, Frimer M, Kuo D, Reimers LL, Mehta K, Mutyala S, Huang GS, Hou JY, Goldberg GL. Phase II trial of adjuvant pelvic radiation “sandwiched” between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma. Gynecologic Oncology 2011, 124: 21-25. PMID: 22035806, PMCID: PMC3681611, DOI: 10.1016/j.ygyno.2011.10.007.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBrachytherapyCarboplatinCarcinoma, PapillaryCystadenocarcinoma, SerousDose Fractionation, RadiationDrug Administration ScheduleFemaleHumansMiddle AgedNeoplasm StagingPaclitaxelRadiotherapy, AdjuvantUterine NeoplasmsConceptsAdjuvant pelvic radiationCycles of paclitaxelCycles of chemotherapyRadiation therapyPelvic radiationCarboplatin chemotherapyUterine papillary serous carcinomaExtra-uterine diseaseModality adjuvant therapyNon-hematologic toxicitiesPrescribed radiation therapyVisible residual diseasePhase II trialKaplan-Meier methodPapillary serous carcinomaStage 3Stage 1Combination paclitaxelOverall PFSAdjuvant therapyChemotherapy cyclesII trialMedian ageResidual diseaseSerous carcinoma
2009
A phase II study of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine and ovarian cancers
Gupta D, Owers RL, Kim M, Kuo DY, Huang GS, Shahabi S, Goldberg GL, Einstein MH. A phase II study of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine and ovarian cancers. Gynecologic Oncology 2009, 113: 327-330. PMID: 19307014, PMCID: PMC4451225, DOI: 10.1016/j.ygyno.2009.02.018.Peer-Reviewed Original ResearchConceptsWeekly topotecanClinical benefitOverall survivalOvarian cancerGrade 3 non-hematologic toxicityKaplan-Meier statistical methodNon-hematologic toxicitiesPrior chemotherapy regimensCycles of chemotherapyGrade 3 toxicityMedian overall survivalPhase II studyPhase II trialMajority of patientsEpithelial ovarian cancerOverall response ratePlatinum-resistant tumorsDose delaysEligible patientsRustin criteriaChemotherapy regimensII trialUnacceptable toxicityII studyMedian duration