2024
Sacituzumab govitecan in heavily pretreated, platinum-resistant high grade serous ovarian cancer
Greenman M, Bellone S, Demirkiran C, Hartwich T, Santin A. Sacituzumab govitecan in heavily pretreated, platinum-resistant high grade serous ovarian cancer. Gynecologic Oncology Reports 2024, 54: 101459. PMID: 39108617, PMCID: PMC11300917, DOI: 10.1016/j.gore.2024.101459.Peer-Reviewed Original ResearchHigh grade serous ovarian cancerAntibody-drug conjugatesSerous ovarian cancerSacituzumab govitecanOvarian cancerTreatment optionsPlatinum-resistant ovarian cancer patientsDose-limiting toxicityOvarian cancer patientsNovel treatment optionsPartial responseRecurrent diseaseDose reductionCancer patientsClinical trialsBackground treatmentTargeted treatmentChemotherapyTreatmentCancerDoseDiseaseOptionsTrop2PatientsRandomized 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 ratePatientsIncreased von Willebrand and Factor VIII plasma levels in gynecologic patients with Post-Acute-COVID-Sequela (PASC)/Long COVID
Bellone S, Siegel E, Scheim D, Santin A. Increased von Willebrand and Factor VIII plasma levels in gynecologic patients with Post-Acute-COVID-Sequela (PASC)/Long COVID. Gynecologic Oncology Reports 2024, 51: 101324. PMID: 38273933, PMCID: PMC10809113, DOI: 10.1016/j.gore.2024.101324.Peer-Reviewed Original ResearchElevated von Willebrand factorFactor VIII levelsVon Willebrand factorLong COVIDGynecologic patientsVIII levelsControl patientsD-dimerPlasma levelsFactor VIIID-dimer levelsPost-acute sequelaeLong COVID symptomsFactor VIII plasma levelsMicrovascular damageMicrovascular inflammationRed blood cellsThrombotic complicationsAcute infectionLC patientsPersistent inflammationPathophysiological mechanismsCancer patientsCOVID symptomsPatients
2023
Increased serum 1,25-dihydroxyvitamin D levels in gynecologic cancer patients with Post-Acute-Covid-Sequela (PASC)/Long COVID
Bellone S, Siegel E, Santin A. Increased serum 1,25-dihydroxyvitamin D levels in gynecologic cancer patients with Post-Acute-Covid-Sequela (PASC)/Long COVID. Gynecologic Oncology Reports 2023, 50: 101301. PMID: 38029227, PMCID: PMC10654147, DOI: 10.1016/j.gore.2023.101301.Peer-Reviewed Original ResearchGynecologic cancer patientsLong COVIDCancer patientsVitamin DPotent anti-inflammatory activityDihydroxyvitamin D levelsPost-acute sequelaeLong COVID symptomsAnti-inflammatory activityMental health impairmentControl cancer patientsExtrarenal conversionPost-AcuteControl patientsAcute infectionBone healthLC patientsPersistent inflammationD levelsCOVID symptomsImmune cellsPlasmatic levelsNovel biomarkersPatientsAbnormal levelsICG 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 identificationLymphPatientsMalignancyHospitalPembrolizumab with chemotherapy, with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer
McNamara B, Chang Y, Mutlu L, Harold J, Santin A. Pembrolizumab with chemotherapy, with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer. Expert Opinion On Biological Therapy 2023, 23: 227-233. PMID: 36800548, DOI: 10.1080/14712598.2023.2182679.Peer-Reviewed Original ResearchConceptsUse of pembrolizumabCervical cancerStandard chemotherapyMetastatic PD-L1Recurrent cervical cancerMetastatic cervical cancerNon-expressing tumorsVEGF therapyPD-L1Clinical efficacyGlobal morbidityPharmacologic propertiesChemotherapyPembrolizumabBevacizumabCancerRecurrentTreatmentTolerabilityFurther benefitImmunotherapyContraindicationsMorbidityEvidencePatientsChapter 3 Ovarian carcinosarcoma
Tymon-Rosario J, Chui M, Santin A. Chapter 3 Ovarian carcinosarcoma. 2023, 41-54. DOI: 10.1016/b978-0-323-82938-0.00003-3.Peer-Reviewed Original ResearchHigh-grade serous ovarian carcinomaSurvival of womenEpithelial ovarian cancerSerous ovarian carcinomaEpithelial-mesenchymal transitionCarcinosarcoma patientsGynecologic tractHistologic subtypeOvarian carcinosarcomaAggressive diseaseAggressive malignancyCarcinoma componentOvarian tumorsClinical managementOvarian carcinomaClinical trialsOvarian cancerSarcomatous elementsAggressive natureCarcinosarcomaTumorsDiseaseSurvivalMolecular studiesPatients
2022
O018/#482 Updated safety of lenvatinib + pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775
Makker V, Colombo N, Herráez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Xie R, Zale M, Mckenzie J, Barresi G, Lorusso D. O018/#482 Updated safety of lenvatinib + pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775. 2022, a11-a11. DOI: 10.1136/ijgc-2022-igcs.20.Peer-Reviewed Original Research2022-LBA-325-ESGO Patients with newly diagnosed ovarian cancer treated with maintenance rucaparib: exploratory biomarker analysis from the phase 3 ATHENA-MONO study (GOG-3020/ENGOT-ov45; NCT03522246)
Oaknin A, Kristeleit R, Mahdi H, Lim M, de Vivo R, Salinas E, Wilson M, Liontos M, Santin A, Provencher D, Demirkiran F, Willmott L, Chudecka-Głaz A, Herzog T, Beiner M, Copeland L, McNeish I, Lin K, Monk B. 2022-LBA-325-ESGO Patients with newly diagnosed ovarian cancer treated with maintenance rucaparib: exploratory biomarker analysis from the phase 3 ATHENA-MONO study (GOG-3020/ENGOT-ov45; NCT03522246). 2022, a472.1-a472. DOI: 10.1136/ijgc-2022-esgo.1018.Peer-Reviewed Original ResearchEndometrial Cancer in Reproductive Age: Fertility-Sparing Approach and Reproductive Outcomes
Mutlu L, Manavella D, Gullo G, McNamara B, Santin A, Patrizio P. Endometrial Cancer in Reproductive Age: Fertility-Sparing Approach and Reproductive Outcomes. Cancers 2022, 14: 5187. PMID: 36358604, PMCID: PMC9656291, DOI: 10.3390/cancers14215187.Peer-Reviewed Original ResearchFertility-preserving approachEndometrial cancerLow-grade endometrial cancerFertility sparing approachStandard surgical treatmentCommon gynecologic malignancyGynecologic malignanciesOncologic outcomesSurgical treatmentPatient goalsReproductive ageReproductive outcomesClose monitoringCancerYoung womenConservative approachFertility goalsReproductive technologiesPatientsWomenAgeOutcomesEarly stagesHysterectomyMalignancy2022-RA-653-ESGO The impact of histology, prior therapy, and dMMR status on lenvatinib + pembrolizumab outcomes in patients with advanced endometrial cancer: A subgroup analysis of Study 309/KEYNOTE-775
Lorusso D, Makker V, Herraez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Yonemori K, Kim Y, Guerra Alia E, Sanli U, Huang J, McKenzie J, Barresi G, Colombo N. 2022-RA-653-ESGO The impact of histology, prior therapy, and dMMR status on lenvatinib + pembrolizumab outcomes in patients with advanced endometrial cancer: A subgroup analysis of Study 309/KEYNOTE-775. 2022, a102.1-a102. DOI: 10.1136/ijgc-2022-esgo.223.Peer-Reviewed Original Research525MO Updated efficacy and safety of lenvatinib (LEN) + pembrolizumab (pembro) vs treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775
Makker V, Colombo N, Herraez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Huang J, McKenzie J, Barresi G, Lorusso D. 525MO Updated efficacy and safety of lenvatinib (LEN) + pembrolizumab (pembro) vs treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775. Annals Of Oncology 2022, 33: s785-s786. DOI: 10.1016/j.annonc.2022.07.653.Peer-Reviewed Original Research20MO Time to deterioration in quality of life in patients (pts) with advanced endometrial cancer (aEC) treated with lenvatinib plus pembrolizumab (L+P) or treatment of physician’s choice (TPC)
Lorusso D, Colombo N, Herraez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Kim Y, McCormack M, Massaad R, Nguyen A, Zhao Q, McKenzie J, Prabhu V, Makker V. 20MO Time to deterioration in quality of life in patients (pts) with advanced endometrial cancer (aEC) treated with lenvatinib plus pembrolizumab (L+P) or treatment of physician’s choice (TPC). Annals Of Oncology 2022, 33: s391-s392. DOI: 10.1016/j.annonc.2022.04.038.Peer-Reviewed Original ResearchRandomised 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 cancerIxabepilonePFSCancerBevacizumabPatientsLenvatinib plus Pembrolizumab for Advanced Endometrial Cancer
Makker V, Colombo N, Casado Herráez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. New England Journal Of Medicine 2022, 386: 437-448. PMID: 35045221, DOI: 10.1056/nejmoa2108330.Peer-Reviewed Original ResearchConceptsAdvanced endometrial cancerProgression-free survivalEndometrial cancerOverall survivalMedian progression-free survivalPlatinum-based chemotherapy regimenLonger progression-free survivalEnd pointBlinded independent central reviewMedian overall survivalPrimary end pointPhase 3 trialResponse Evaluation CriteriaPlatinum-based chemotherapyIndependent central reviewChemotherapy regimenAdverse eventsStandard therapyCentral reviewPembrolizumabGrade 3LenvatinibChemotherapyPhysician's choicePatientsRandomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial
Powell MA, Filiaci VL, Hensley ML, Huang HQ, Moore KN, Tewari KS, Copeland LJ, Secord AA, Mutch DG, Santin A, Warshal DP, Spirtos NM, DiSilvestro PA, Ioffe OB, Miller DS. Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial. Journal Of Clinical Oncology 2022, 40: 968-977. PMID: 35007153, PMCID: PMC8937015, DOI: 10.1200/jco.21.02050.Peer-Reviewed Original ResearchConceptsProgression-free survivalUterine carcinosarcomaOvarian carcinosarcomaEligible patientsHazard ratioMore patientsPC armMedian progression-free survivalRandomized phase III trialNRG Oncology trialsPhase III trialsPI armsGenitourinary hemorrhageHematologic toxicityMedian OSIII trialsLonger OSStandard treatmentGreater death rateStage IIINoninferiority designOncology trialsPatientsStage IStage IV
2021
O002/#43 Randomized phase 3 study of lenvatinib plus pembrolizumab for advanced endometrial cancer (aec): subgroup analysis of patients with DNA mismatch repair deficient (DMMR) tumors
Makker V, Colombo N, Herráez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Banerjee S, Monk B, Ushijima K, Penson R, Kristeleit R, Fabbro M, Orlando M, Mackay H, Ren M, Orlowski R, Dutta L, Lorusso D. O002/#43 Randomized phase 3 study of lenvatinib plus pembrolizumab for advanced endometrial cancer (aec): subgroup analysis of patients with DNA mismatch repair deficient (DMMR) tumors. International Journal Of Gynecological Cancer 2021, 31: a1-a2. DOI: 10.1136/ijgc-2021-igcs.2.Peer-Reviewed Original ResearchTPC groupDNA mismatch repair deficient tumorsPrior platinum-based chemotherapy regimenMismatch repair-proficient tumorsPlatinum-based chemotherapy regimenTreatment-emergent adverse eventsRandomized phase 3 studyMismatch repair-deficient tumorsBlinded independent central reviewManageable safety profileAdvanced endometrial cancerPhase 3 studyPlatinum-based therapyIndependent central reviewRepair-deficient tumorsRECIST v1.1Chemotherapy regimenAdverse eventsEndometrial cancerProficient tumorsCentral reviewDMMR patientsSafety profileSubgroup analysisPatientsFinancial toxicity in patients with gynecologic malignancies: a cross sectional study
Zeybek B, Webster E, Pogosian N, Tymon-Rosario J, Balch A, Altwerger G, Clark M, Menderes G, Huang G, Azodi M, Ratner ES, Schwartz PE, Santin AD, Andikyan V. Financial toxicity in patients with gynecologic malignancies: a cross sectional study. Journal Of Gynecologic Oncology 2021, 32: e87. PMID: 34431257, PMCID: PMC8550931, DOI: 10.3802/jgo.2021.32.e87.Peer-Reviewed Original ResearchConceptsCross-sectional studyGynecologic malignanciesFinancial toxicityPatient demographicsSectional studyMalignancy typeGynecologic oncology patientsOvarian cancer patientsPatient/diseaseCost of careFinancial burdenHigh financial burdenTreatment regimenHigh financial toxicityOncology patientsDisease characteristicsGynecologic cancerCancer careCancer patientsRisk factorsClinical trialsCOST scoreMedian COST scorePatientsSignificant burden145 Characterization of adverse reactions in patients with advanced endometrial cancer (aec) receiving lenvatinib + pembrolizumab (Study 309/KEYNOTE-775)
Colombo N, Lorusso D, Santin A, Kim Y, Herráez A, Yonemori K, Fujiwara K, Colomba E, Miller D, Pignata S, Monk B, Guerra E, Kristeleit R, Orlando M, Sanli U, Dutta L, Orlowski R, Ren M, Makker V. 145 Characterization of adverse reactions in patients with advanced endometrial cancer (aec) receiving lenvatinib + pembrolizumab (Study 309/KEYNOTE-775). International Journal Of Gynecological Cancer 2021, 31: a78-a78. DOI: 10.1136/ijgc-2021-esgo.120.Peer-Reviewed Original ResearchPalmar-plantar erythrodysesthesiaLenvatinib dose reductionAdverse reactionsMusculoskeletal painDose reductionPrior platinum-based therapyAEC patientsTarget lesion diametersCommon adverse reactionsAdvanced endometrial cancerManagement of patientsPlatinum-based therapyQd poEndometrial cancerTreatment initiationMedian timeEndometrial carcinomaHypertensionLenvatinibPrompt identificationPhysician's choiceDiarrheaPatientsFirst onsetMeaningful improvementsMinimal uterine serous carcinoma and endometrial polyp: a close clinicopathological relationship
Assem H, Rottmann D, Finkelstein A, Wang M, Ratner E, Santin AD, Buza N, Hui P. Minimal uterine serous carcinoma and endometrial polyp: a close clinicopathological relationship. Human Pathology 2021, 118: 1-8. PMID: 34508766, DOI: 10.1016/j.humpath.2021.09.001.Peer-Reviewed Original ResearchConceptsMinimal uterine serous carcinomaEndometrial polypsUterine serous carcinomaSerous carcinomaHigh stage patientsLow stage patientsPelvic washing cytologyAdvanced stage diseaseEndometrial serous carcinomaHigher stage diseaseLower tumor stageClinical outcome assessmentClose topographic relationshipBackground endometriumExtrauterine diseaseExtrauterine spreadStage diseaseExcellent prognosisLymphovascular invasionClinicopathological relationshipWashing cytologyTumor stageHigh riskPatientsLarge series