2023
Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results.
Carneiro B, Perets R, Dowlati A, LoRusso P, Yonemori K, He L, Munasinghe W, Noorani B, Johnson E, Zugazagoitia J. Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results. Journal Of Clinical Oncology 2023, 41: 3027-3027. DOI: 10.1200/jco.2023.41.16_suppl.3027.Peer-Reviewed Original ResearchNon-small cell lung cancerSmall cell lung cancerOverall response rateCommon adverse eventsRefractory solid tumorsCell lung cancerSCLC cohortBest overall responseAdverse eventsMonotherapy cohortTaxane therapyLung cancerSolid tumorsConfirmed overall response rateDose-expansion phaseOngoing phase 1Phase 2 dosePrior taxane therapyTolerable safety profileDisease control rateGrade 3/4 neutropeniaOpen-label studyDose-escalation phasePhase 1 studySingle-agent activityPhase Ib study of HSP90 inhibitor, onalespib (AT13387), in combination with paclitaxel in patients with advanced triple-negative breast cancer
Williams N, Quiroga D, Johnson C, Brufsky A, Chambers M, Bhattacharya S, Patterson M, Sardesai S, Stover D, Lustberg M, Noonan A, Cherian M, Bystry D, Hill K, Chen M, Phelps M, Grever M, Stephens J, Ramaswamy B, Carson W, Wesolowski R. Phase Ib study of HSP90 inhibitor, onalespib (AT13387), in combination with paclitaxel in patients with advanced triple-negative breast cancer. Therapeutic Advances In Medical Oncology 2023, 15: 17588359231217976. PMID: 38152697, PMCID: PMC10752118, DOI: 10.1177/17588359231217976.Peer-Reviewed Original ResearchAdvanced triple-negative breast cancerTriple-negative breast cancerProgression-free survivalDuration of responseOverall response ratePrior taxane therapyAdverse eventsTaxane therapyCombination therapyBreast cancerMedian DORMedian progression-free survivalNon-hematologic adverse eventsPhase Ib studyPhase Ib trialPhase II doseAcceptable toxicity profileDose-limiting toxicityDrug interaction profileIb trialIntravenous paclitaxelPaclitaxel efficacyExpansion cohortCombination regimenMetastatic disease
2022
A preliminary, prospective study of peripheral neuropathy and cognitive function in patients with breast cancer during taxane therapy
Ibrahim EY, Munshani S, Domenicano I, Rodwin R, Nowak RJ, Pusztai L, Lustberg M, Ehrlich BE. A preliminary, prospective study of peripheral neuropathy and cognitive function in patients with breast cancer during taxane therapy. PLOS ONE 2022, 17: e0275648. PMID: 36206298, PMCID: PMC9543876, DOI: 10.1371/journal.pone.0275648.Peer-Reviewed Original ResearchConceptsNeurological side effectsSide effectsBreast cancerTaxane exposureProgressive neurological changesTaxane-based chemotherapyNon-interventional studyWeeks of treatmentEnd of treatmentIrreversible side effectsCourse of treatmentQuality of lifeTaxane therapyPeripheral neuropathyProspective studyPeripheral bloodBlood levelsCancer survivalNeuronal viabilityNeurological changesEffective treatmentChemotherapyCognitive impairmentPatientsPotential protein biomarkers
2021
A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results.
Tolcher A, Carneiro B, Dowlati A, Razak A, Chae Y, Villella J, Coppola S, Englert S, Phillips A, Souers A, Salman Z, Penugonda S, Powderly J, LoRusso P. A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results. Journal Of Clinical Oncology 2021, 39: 3015-3015. DOI: 10.1200/jco.2021.39.15_suppl.3015.Peer-Reviewed Original ResearchRefractory solid tumorsAdverse eventsCell lung cancerSolid tumorsLymphocyte countLung cancerNon-small cell lung cancerSmall cell lung cancerMedian age 62 yearsCommon adverse eventsDose-expansion phasePhase 2 dosePrior systemic therapyTolerable safety profileFatal adverse eventsFatal cardiac arrestOverall response rateAge 62 yearsDose-escalation resultsAnti-tumor activityECOG 0ECOG 1RECIST v1.1Taxane therapyMedian duration
2020
Multicenter Phase II Study of Cabazitaxel in Advanced Gastroesophageal Cancer: Association of HER2 Expression and M2-Like Tumor-Associated Macrophages with Patient Outcome
Shah MA, Enzinger P, Ko AH, Ocean AJ, Philip PA, Thakkar PV, Cleveland K, Lu Y, Kortmansky J, Christos PJ, Zhang C, Kaur N, Elmonshed D, Galletti G, Sarkar S, Bhinder B, Pittman ME, Plotnikova OM, Kotlov N, Frenkel F, Bagaev A, Elemento O, Betel D, Giannakakou P, Lenz HJ. Multicenter Phase II Study of Cabazitaxel in Advanced Gastroesophageal Cancer: Association of HER2 Expression and M2-Like Tumor-Associated Macrophages with Patient Outcome. Clinical Cancer Research 2020, 26: 4756-4766. PMID: 32641434, PMCID: PMC8209413, DOI: 10.1158/1078-0432.ccr-19-3920.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overEsophageal NeoplasmsEsophagogastric JunctionFemaleGene AmplificationGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateMaleMiddle AgedProgression-Free SurvivalReceptor, ErbB-2Response Evaluation Criteria in Solid TumorsStomach NeoplasmsTaxoidsTumor-Associated MacrophagesConceptsProgression-free survivalMulticenter phase II studyPhase II studyPFS ratesII studyMacrophage signatureHER2 amplificationGastric cancerEfficacy targetAdvanced gastroesophageal cancerM2 macrophage signaturePrior taxane therapyCommon adverse eventsAdvanced gastric cancerMetastatic gastric cancerM2-like tumorImproved disease controlPrior therapyRECIST 1.1Taxane efficacyPrimary endpointTaxane therapyAdverse eventsGastroesophageal cancerMetastatic disease
2018
Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. New England Journal Of Medicine 2018, 379: 2108-2121. PMID: 30345906, DOI: 10.1056/nejmoa1809615.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerProgression-free survivalMedian progression-free survivalMedian overall survivalNab-paclitaxelBreast cancerOverall survivalPD-L1Adverse eventsTreat analysisPositive tumorsAdvanced triple-negative breast cancerDeath ligand 1 (PD-L1) expressionAdjuvant taxane therapyPrimary end pointLigand 1 expressionPhase 3 trialNew adverse effectsTreat populationTaxane therapyLiver metastasesAggressive diseasePoor outcomeSafety profile
2017
Gait, balance, and patient-reported outcomes during taxane-based chemotherapy in early-stage breast cancer patients
Monfort S, Pan X, Patrick R, Ramaswamy B, Wesolowski R, Naughton M, Loprinzi C, Chaudhari A, Lustberg M. Gait, balance, and patient-reported outcomes during taxane-based chemotherapy in early-stage breast cancer patients. Breast Cancer Research And Treatment 2017, 164: 69-77. PMID: 28374323, PMCID: PMC5510549, DOI: 10.1007/s10549-017-4230-8.Peer-Reviewed Original ResearchConceptsBreast cancer patientsPatient-reported outcomesTaxane-based chemotherapyCancer patientsChemotherapy cyclesEarly-stage breast cancer patientsPatient-reported symptom severityDevelopment of CIPNSubsequent chemotherapy cyclesFirst chemotherapy cyclePatient-reported symptomsDose-limiting toxicityOutpatient oncology clinicsSelf-reported symptomsTaxane infusionTaxane therapyTaxane treatmentCIPN symptomsDose intensityPeripheral neuropathyOncology clinicPatient functionPhysical functionFunctional deficitsGait testing
2015
Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors
Abu-Khalaf MM, Baumgart MA, Gettinger SN, Doddamane I, Tuck DP, Hou S, Chen N, Sullivan C, Lezon-Geyda K, Zelterman D, Hatzis C, Deshpande H, Digiovanna MP, Azodi M, Schwartz PE, Harris LN. Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors. Cancer 2015, 121: 1817-1826. PMID: 25649370, DOI: 10.1002/cncr.29254.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityIntravenous nab-paclitaxelPhase 1b studyAdvanced solid tumorsNab-paclitaxelFDG activityDay 1Solid tumorsNanoparticle albumin-bound paclitaxelMammalian targetWeekly oral doseAcceptable safety profileRapamycin inhibitor sirolimusAlbumin-bound paclitaxelClinical trial endpointsExploratory gene expression analysisPositron emission tomographyStable diseaseTaxane therapyPartial responseWeekly doseComplete responseOral sirolimusPharmacodynamic assessmentOral dose
2013
Novel Functional Assay for Spindle-Assembly Checkpoint by Cyclin-Dependent Kinase Activity to Predict Taxane Chemosensitivity in Breast Tumor Patient
Torikoshi Y, Gohda K, Davis ML, Symmans WF, Pusztai L, Kazansky A, Nakayama S, Yoshida T, Matsushima T, Hortobagyi GN, Ishihara H, Kim SJ, Noguchi S, Ueno NT. Novel Functional Assay for Spindle-Assembly Checkpoint by Cyclin-Dependent Kinase Activity to Predict Taxane Chemosensitivity in Breast Tumor Patient. Journal Of Cancer 2013, 4: 697-702. PMID: 24312139, PMCID: PMC3842438, DOI: 10.7150/jca.6248.Peer-Reviewed Original ResearchTaxane-containing chemotherapyClinical responsePreoperative chemotherapyTaxane-induced cell deathAnthracycline-based treatmentFine-needle aspiration biopsyLarge prospective studiesBreast cancer patientsCyclin-dependent kinase 1Taxane-resistant tumorsLogistic regression analysisTaxane-containing therapyBreast tumor patientsDysfunction groupTaxane therapyPathologic responseProspective studyCancer patientsPredictive biomarkersTumor patientsBreast cancerClinicopathologic parametersAspiration biopsyBiopsy samplesPatients
2007
Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study
Burstein HJ, Keshaviah A, Baron AD, Hart RD, Lambert‐Falls R, Marcom PK, Gelman R, Winer EP. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study. Cancer 2007, 110: 965-972. PMID: 17614302, DOI: 10.1002/cncr.22885.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlopeciaAnemiaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsConstipationDisease ProgressionDrug Administration ScheduleFatigueFemaleHumansKaplan-Meier EstimateMiddle AgedNauseaNeoplasm MetastasisPaclitaxelProspective StudiesReceptor, ErbB-2TrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsMetastatic breast cancerBreast cancerTrastuzumab armEpisodes of cardiotoxicityFirst-line therapyDermatologic toxicitiesEvaluable patientsPrior chemotherapyVinorelbine therapyAdvanced diseaseChemotherapy regimenEligible patientsGastrointestinal toxicityPoor accrualTaxane chemotherapyTaxane therapyMore anemiaMedian timeTrastuzumab treatmentFluid retentionDisease progressionChemotherapy agentsTreatment decisionsVinorelbineSide effectsPilot study of regional, hepatic intra‐arterial paclitaxel in patients with breast carcinoma metastatic to the liver
Camacho LH, Kurzrock R, Cheung A, Barber DF, Gupta S, Madoff DC, Wallace MJ, Kim EE, Curley SA, Hortobagyi GN, Mavligit G. Pilot study of regional, hepatic intra‐arterial paclitaxel in patients with breast carcinoma metastatic to the liver. Cancer 2007, 109: 2190-2196. PMID: 17464952, DOI: 10.1002/cncr.22672.Peer-Reviewed Original ResearchConceptsDominant liver metastasisBreast carcinomaTaxane exposureLiver metastasesAntitumor activityCommon treatment-related toxicitiesHepatic intra-arterial therapyPatient underwent liver resectionCourses of paclitaxelUnderwent liver resectionMean patient ageTreatment-related toxicityHepatic arterial infusionIntra-arterial therapyProcedure-related complicationsBreast carcinoma metastaticMetastatic breast carcinomaIntra-arterial catheterPercutaneous transfemoral approachTime of treatmentHepatic infusionStable diseaseCarcinoma metastaticPaclitaxel therapyTaxane therapy
2006
Pilot study of regional hepatic intra-arterial (HIA) paclitaxel in patients (Pts) with breast carcinoma metastatic to the liver
Mavligit G, Kurzrock R, Cheung A, Gupta S, Madoff D, Wallace M, Kim E, Curley S, Hortobagyi G, Camacho L. Pilot study of regional hepatic intra-arterial (HIA) paclitaxel in patients (Pts) with breast carcinoma metastatic to the liver. Journal Of Clinical Oncology 2006, 24: 10626-10626. DOI: 10.1200/jco.2006.24.18_suppl.10626.Peer-Reviewed Original ResearchAnti-tumor activityBreast carcinomaTaxane exposureDominant liver metastasisHepatic arterial therapyPrevious treatment regimensUnderwent liver resectionMean hospital stayBreast carcinoma metastaticMetastatic breast carcinomaIntra-arterial catheterPercutaneous transfemoral approachGood anti-tumor activityMost common treatmentTime of treatmentAdjuvant regimensArterial therapyCarcinoma metastaticDisease stabilizationHospital stayPaclitaxel therapyTaxane therapyLiver involvementLiver metastasesLiver resectionTrastuzumab and vinorelbine or taxane chemotherapy for HER2+ metastatic breast cancer: The TRAVIOTA study
Burstein H, Keshaviah A, Baron A, Hart R, Lambert-Falls R, Marcom P, Gelman R, Winer E. Trastuzumab and vinorelbine or taxane chemotherapy for HER2+ metastatic breast cancer: The TRAVIOTA study. Journal Of Clinical Oncology 2006, 24: 650-650. DOI: 10.1200/jco.2006.24.18_suppl.650.Peer-Reviewed Original ResearchMetastatic breast cancerAdvanced breast cancerBreast cancerTaxane chemotherapyResponse rateMore frequent grade 3Stage IV breast cancerComparable clinical activityFrequent grade 3Protocol-based therapySide effect profileHigh response rateDose delaysEligible patientsMeasurable diseasePrior chemotherapyVinorelbine therapyWeekly taxanesWeekly vinorelbineChemotherapy regimenPrimary endpointTaxane therapyHematological toxicityEffect profileClinical trials
2005
A retrospective evaluation of second‐line chemotherapy response in hormone‐refractory prostate carcinoma
Rosenberg J, Galsky M, Rohs N, Weinberg V, Oh W, Kelly W, Small E. A retrospective evaluation of second‐line chemotherapy response in hormone‐refractory prostate carcinoma. Cancer 2005, 106: 58-62. PMID: 16329138, DOI: 10.1002/cncr.21559.Peer-Reviewed Original ResearchConceptsHormone-refractory prostate carcinomaProstate-specific antigenPSA decline >Clinical cross-resistanceTaxane chemotherapyProstate carcinomaProstate-specific antigen declines >PSA responseResponse to second-lineTime to PSA progressionRandomized phase II trialTaxane-resistant cell linesTaxane-based therapyFirst-line therapyKaplan-Meier methodIxabepilone treatmentPSA declinePSA progressionTaxane therapyMedian survivalSecond-lineChemotherapy responseIxabepiloneDisease progressionRetrospective evaluationPhosphorylated/Activated HER2 as a Marker of Clinical Resistance to Single Agent Taxane Chemotherapy for Metastatic Breast Cancer
Modi S, DiGiovanna MP, Lu Z, Moskowitz C, Panageas KS, Van Poznak C, Hudis CA, Norton L, Tan L, Stern DF, Carter D, Seidman AD. Phosphorylated/Activated HER2 as a Marker of Clinical Resistance to Single Agent Taxane Chemotherapy for Metastatic Breast Cancer. Cancer Investigation 2005, 23: 483-487. PMID: 16203655, DOI: 10.1080/07357900500201301.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSingle-agent taxane therapyTaxane therapyP-HER2Clinical benefitBreast cancerClinical resistanceSingle-agent taxane chemotherapyUnique predictive informationChi-squared analysisTaxane chemotherapyClinical outcomesClinical progressionTaxane monotherapyHER2 statusClinical trialsPhosphorylated HER2Tumor specimensFunctional assessmentHER2TherapyMonoclonal antibodiesImmunohistochemistrySquared analysisProgression
2004
Phase I Study of the Farnesyltransferase Inhibitor Lonafarnib with Paclitaxel in Solid Tumors
Khuri FR, Glisson BS, Kim ES, Statkevich P, Thall PF, Meyers ML, Herbst RS, Munden RF, Tendler C, Zhu Y, Bangert S, Thompson E, Lu C, Wang XM, Shin DM, Kies MS, Papadimitrakopoulou V, Fossella FV, Kirschmeier P, Bishop WR, Hong WK. Phase I Study of the Farnesyltransferase Inhibitor Lonafarnib with Paclitaxel in Solid Tumors. Clinical Cancer Research 2004, 10: 2968-2976. PMID: 15131032, DOI: 10.1158/1078-0432.ccr-03-0412.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerGrade 4 diarrheaCell lung cancerPartial responseLung cancerMetastatic non-small cell lung cancerSolid tumorsGrade 3 peripheral neuropathyPrincipal grade 3/4 toxicitiesDose level 3Durable partial responseGrade 3 hyperbilirubinemiaPrevious taxane therapyGrade 3/4 toxicitiesGrade 4 neutropeniaPhase II trialDose-limiting toxicityPhase I trialFarnesyltransferase inhibitor lonafarnibNovel farnesyltransferase inhibitorPlasma paclitaxelII trialTaxane therapyCombination regimenMedian duration
2001
Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients
Blum J, Dieras V, Russo P, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients. Cancer 2001, 92: 1759-1768. PMID: 11745247, DOI: 10.1002/1097-0142(20011001)92:7<1759::aid-cncr1691>3.0.co;2-a.Peer-Reviewed Original ResearchConceptsMetastatic breast carcinomaTreatment-related adverse eventsHand-foot syndromeBreast carcinomaAdverse eventsGrade 3 treatment-related adverse eventsCommon treatment-related adverse eventsResponse rateGrade 4 adverse eventsMetastatic breast carcinoma patientsPrevious chemotherapy regimensPrior anthracycline chemotherapyTreatment-related deathsPhase II studyPhase II trialBreast carcinoma patientsSubgroup of patientsOverall response rateCurrent multicenterFluoropyrimidine carbamateOral capecitabineAnthracycline chemotherapyChemotherapy regimensII trialTaxane therapyChemotherapy of Metastatic Breast Cancer: What to Expect in 2001 and Beyond
Esteva F, Valero V, Pusztai L, Boehnke-Michaud L, Buzdar A, Hortobagyi G. Chemotherapy of Metastatic Breast Cancer: What to Expect in 2001 and Beyond. The Oncologist 2001, 6: 133-146. PMID: 11306725, DOI: 10.1634/theoncologist.6-2-133.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerHER-2/neu proteinAnthracycline/taxane combinationsDevelopment of anthracyclineAdvanced breast cancerHigh-dose chemotherapyPrimary breast cancerSingle-agent activityCombination chemotherapy treatmentsNovel biologic therapiesNovel treatment approachesMultidrug resistance inhibitorsTopoisomerase I inhibitorTaxane therapyBiologic therapyPalliative therapyTaxane combinationsProlong survivalTumor supressor geneChemotherapy treatmentTreatment approachesFluoropyrimidine analogsPatientsNeu protein
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