2024
SACI-IO HR+: A randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer.
Garrido-Castro A, Kim S, Desrosiers J, Nanda R, Carey L, Clark A, Sacks R, O'Connor T, Sinclair N, Lo K, Thomas A, Wrabel E, O'Meara T, Lin N, Burstein H, He M, Rimm D, Mittendorf E, Tayob N, Tolaney S. SACI-IO HR+: A randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer. Journal Of Clinical Oncology 2024, 42: lba1004-lba1004. DOI: 10.1200/jco.2024.42.17_suppl.lba1004.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerHR+/HER2- metastatic breast cancerPD-L1 expressionSacituzumab govitecanAntibody drug conjugatesOverall survivalArm BPD-L1Arm ASN-38Study therapyBreast cancerHormone receptor-positive/HER2-negative breast cancerOpen-label phase 2 studyFollow-upDeplete regulatory T cellsFrequent treatment-related toxicitiesHormone receptor-positive/HER2-negativeImproving progression-free survivalTopoisomerase I inhibitor payloadMedian progression-free survivalRandomized phase II trialUpregulated MHC class IT cell effector function
2019
In vitro and in vivo activity of sacituzumab govitecan, an antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (Trop-2) in uterine serous carcinoma
Han C, Perrone E, Zeybek B, Bellone S, Tymon-Rosario J, Altwerger G, Menderes G, Feinberg J, Haines K, Muller Karger ME, Bianchi A, Zammataro L, Manzano A, Bonazzoli E, Manara P, Buza N, Hui P, Ratner E, Silasi DA, Huang GS, Azodi M, Schwartz PE, Lopez S, Santin AD. In vitro and in vivo activity of sacituzumab govitecan, an antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (Trop-2) in uterine serous carcinoma. Gynecologic Oncology 2019, 156: 430-438. PMID: 31839338, DOI: 10.1016/j.ygyno.2019.11.018.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, Monoclonal, HumanizedAntibody-Dependent Cell CytotoxicityAntigens, NeoplasmCamptothecinCell Adhesion MoleculesCell Line, TumorCystadenocarcinoma, SerousFemaleFlow CytometryHumansImmunoconjugatesImmunohistochemistryMiceMice, SCIDMolecular Targeted TherapyRandom AllocationTissue Array AnalysisUterine NeoplasmsXenograft Model Antitumor AssaysConceptsUterine serous carcinomaCell surface antigen 2Sacituzumab govitecanTrop-2 expressionTrop-2Serous carcinomaAntigen 2Advanced/recurrent diseasePrimary uterine serous carcinomaResistant human tumorsSignificant bystander killingUSC patientsUSC xenograftsRecurrent diseaseClinical responseEndometrial cancerAggressive variantPoor prognosisPreclinical activityPrimary tumorIntravenous administrationClinical developmentUSC samplesActive metaboliteSN-3893 Sacituzumab govitecan in uterine and ovarian carcinosarcomas
Lopez S, Perrone E, Zeybek B, Bellone S, Manzano A, Zammataro L, Han C, Altwerger G, Angioli R, Santin A. 93 Sacituzumab govitecan in uterine and ovarian carcinosarcomas. International Journal Of Gynecological Cancer 2019, 29: a48. DOI: 10.1136/ijgc-2019-igcs.93.Peer-Reviewed Original ResearchCS cell linesAntibody-drug conjugatesSacituzumab govitecanTrop-2 expressionTrop-2Negative tumorsCell linesControl antibody drug conjugatesNovel antibody-drug conjugateAggressive gynecologic malignancyGreater antitumor effectPrimary tumor cell linesRemarkable antitumor activityAggressive carcinosarcomasGynecologic malignanciesOvarian carcinosarcomaPrimary tumorClinical trialsEpithelial tumorsSarcomatous elementsAntitumor effectsAntigen 2CarcinosarcomaActive metaboliteSN-38Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer
Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. New England Journal Of Medicine 2019, 380: 741-751. PMID: 30786188, DOI: 10.1056/nejmoa1814213.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnemiaAntibodies, Monoclonal, HumanizedAntigens, NeoplasmAntineoplastic AgentsCamptothecinCell Adhesion MoleculesDiarrheaDose-Response Relationship, DrugFemaleHumansImmunoconjugatesInfusions, IntravenousIrinotecanMaleMiddle AgedNeutropeniaProgression-Free SurvivalSurvival RateTriple Negative Breast NeoplasmsConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerSacituzumab govitecan-hziyProgression-free survivalClinical benefit rateIndependent central reviewBreast cancerResponse rateAdverse eventsOverall survivalCentral reviewBenefit rateHuman trophoblast cell surface antigen 2Refractory metastatic triple-negative breast cancerTrophoblast cell surface antigen 2Median progression-free survivalSN-38Shorter progression-free survivalCell surface antigen 2Blinded independent central reviewDurable objective responsesPrevious anticancer therapyUnacceptable toxic effectsObjective response rateMain adverse reactions
2015
Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors.
Wang D, Braiteh F, Lee J, Denlinger C, Shepard D, Chaudhary A, Lin Y, Gao L, Asakiewicz C, Nasroulah F, LoRusso P. Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors. Journal Of Clinical Oncology 2015, 33: 691-691. DOI: 10.1200/jco.2015.33.3_suppl.691.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdvanced malignant solid tumorsPharmacokinetics of irinotecanMalignant solid tumorsMetabolite SN-38Folinic acidSN-38Safety populationStandard therapyEastern Cooperative Oncology Group performance statusSolid tumorsCycle 1Maximum observed drug concentrationFatigue/astheniaPhase II studyKey eligibility criteriaDose-normalized areaNew safety concernsC maxII studyPerformance statusAdverse eventsStudy treatmentIntravenous infusionPlasma concentrations
2006
Pharmacokinetic and safety study of weekly irinotecan and oral capecitabine in patients with advanced solid cancers
Goel S, Desai K, Karri S, Gollamudi R, Chaudhary I, Bulgaru A, Kaubisch A, Goldberg G, Einstein M, Camacho F, Baker S, Mani S. Pharmacokinetic and safety study of weekly irinotecan and oral capecitabine in patients with advanced solid cancers. Investigational New Drugs 2006, 25: 237-245. PMID: 17195945, DOI: 10.1007/s10637-006-9028-1.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveCamptothecinCapecitabineCarboxylesteraseDeoxycytidineDose-Response Relationship, DrugDrug Administration ScheduleDrug InteractionsFemaleFluorouracilHumansInfusions, IntravenousIrinotecanMaleMiddle AgedNeoplasmsNeutropeniaTreatment OutcomeConceptsDrug-drug interactionsDay 1Day 8Open-label phase ISN-38Potential drug-drug interactionsConversion of irinotecanGrade 3 diarrheaCycles of chemotherapyAdvanced solid cancersAdvanced solid tumorsDose level 5Diarrhea/vomitingWarrants further evaluationSynergistic anti-cancer activitySN-38GWarrants further studyFatal neutropeniaOral capecitabineAnti-cancer activityDose cohortsEvaluable patientsEscalation trialNegative sepsisMin infusion
2004
501 Prospective UGT1A1 genotyping in a phase I study of safety and pharmacokinetics of liposome encapsulated SN-38 (LE-SN38)
LoRusso P, Fishman M, Kraut E, Gordon M, Elsayed Y, Steinberg J, Nieves J, Wanaski S, Dul J, Sherman J. 501 Prospective UGT1A1 genotyping in a phase I study of safety and pharmacokinetics of liposome encapsulated SN-38 (LE-SN38). European Journal Of Cancer Supplements 2004, 2: 153. DOI: 10.1016/s1359-6349(04)80509-3.Peer-Reviewed Original ResearchPharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients
Kraut E, Fishman M, Lorusso P, Steinberg J, Nieves J, Fetterly G, Darling I, Wanaski S, Dul J, Sherman J. Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients. Journal Of Clinical Oncology 2004, 22: 2501-2501. DOI: 10.1200/jco.2004.22.14_suppl.2501.Peer-Reviewed Original ResearchPharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients
Kraut E, Fishman M, Lorusso P, Steinberg J, Nieves J, Fetterly G, Darling I, Wanaski S, Dul J, Sherman J. Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients. Journal Of Clinical Oncology 2004, 22: 2501-2501. DOI: 10.1200/jco.2004.22.90140.2501.Peer-Reviewed Original Research
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