2021
Expected Medium- and Long-Term Impact of the COVID-19 Outbreak in Oncology
Onesti CE, Tagliamento M, Curigliano G, Harbeck N, Bartsch R, Wildiers H, Tjan-Heijnen V, Martin M, Rottey S, Generali D, Campone M, Cristofanilli M, Pusztai L, Peeters M, Berchem G, Cortes J, Ruhstaller T, Ciruelos E, Rugo HS, Jerusalem G. Expected Medium- and Long-Term Impact of the COVID-19 Outbreak in Oncology. JCO Global Oncology 2021, 7: go.20.00589. PMID: 33529077, PMCID: PMC8081548, DOI: 10.1200/go.20.00589.Peer-Reviewed Original ResearchConceptsMedical oncologistsCOVID-19 positive patientsCOVID-19 outbreakUse of telemedicineClinical trial activityAffected modalityPalliative treatmentOncology unitLong-term impactNational registryPostacute phaseClinical activityMultidisciplinary meetingOncologic activityLocal registryHealthcare staffTreatment adaptationPatientsEarly cessationTrial activityHealthcare systemCOVID-19 pandemicOncologistsRegistrySignificant reduction
2018
Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer
Dickler MN, Saura C, Richards DA, Krop IE, Cervantes A, Bedard PL, Patel MR, Pusztai L, Oliveira M, Cardenas AK, Cui N, Wilson TR, Stout TJ, Wei MC, Hsu JY, Baselga J. Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer. Clinical Cancer Research 2018, 24: 4380-4387. PMID: 29793946, PMCID: PMC6139036, DOI: 10.1158/1078-0432.ccr-18-0613.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsFemaleFulvestrantHumansImidazolesMiddle AgedMutationOxazepinesReceptor, ErbB-2Receptors, EstrogenConceptsAdverse eventsClinical activityBreast cancerMutation statusOpen-label phase II studyHR-positive breast cancerHigher objective response rateConfirmatory phase III trialNCI CTCAE v4.0Median treatment durationObjective response ratePhase II studySerious adverse eventsNew safety signalsPhase III trialsPositive breast cancerClin Cancer ResIntramuscular fulvestrantMeasurable diseaseRECIST v1.1II studyIII trialsPostmenopausal womenUnacceptable toxicityTumor response
2013
Phase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer.
James E, Chung G, Sowers N, Clark M, Lilian R, Abraham G, Chmael S, Cappiello M, DiGiovanna M, Hofstatter E, Sanft T, Israel G, Pusztai L, Harris L, Abu-Khalaf M. Phase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer. Journal Of Clinical Oncology 2013, 31: 154-154. DOI: 10.1200/jco.2013.31.26_suppl.154.Peer-Reviewed Original ResearchDose-expansion phaseGrade 3 non-hematological toxicityGrade 4 febrile neutropeniaCycle-1 DLTGrade 3 fatigueGrade 3/4 toxicitiesGrade 4 neutropeniaGrade 4 thrombocytopeniaMedian age 51Non-hematological toxicitiesObjective response rateAdvanced breast cancerDose-escalation phaseModest clinical activityHDAC inhibitor vorinostatClinical trial informationHistone deacetylase inhibitorsFebrile neutropeniaStable diseaseObjective responsePrior linesHematological toxicityTreatment delayClinical activityBreast cancer
2008
Imatinib mesylate (Gleevec®) in advanced breast cancer-expressing C-Kit or PDGFR-β: clinical activity and biological correlations
Cristofanilli M, Morandi P, Krishnamurthy S, Reuben JM, Lee B, Francis D, Booser DJ, Green MC, Arun BK, Pusztai L, Lopez A, Islam R, Valero V, Hortobagyi GN. Imatinib mesylate (Gleevec®) in advanced breast cancer-expressing C-Kit or PDGFR-β: clinical activity and biological correlations. Annals Of Oncology 2008, 19: 1713-1719. PMID: 18515258, PMCID: PMC2735063, DOI: 10.1093/annonc/mdn352.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic AgentsBenzamidesBreast NeoplasmsBreast Neoplasms, MaleCarcinoma, Ductal, BreastFemaleHumansImatinib MesylateImmunologic FactorsMaleMiddle AgedNeoplasm MetastasisPiperazinesProspective StudiesProtein Kinase InhibitorsProto-Oncogene Proteins c-kitPyrimidinesReceptor, Platelet-Derived Growth Factor betaConceptsMetastatic breast cancerPlatelet-derived growth factor receptorImatinib mesylateC-kitDisease progressionClinical activityB-fibroblast growth factorGrowth factorMedian overall survivalSerious adverse eventsPotential immunosuppressive effectsInterferon-gamma productionVascular endothelial growth factorAngiogenesis-related cytokinesEndothelial growth factorNovel molecular therapiesC-kit expressionGrowth factor receptorAdverse eventsObjective responseOverall survivalTreat analysisDismal prognosisMedian timeImmunomodulatory effects
2006
Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC)
Green M, Pusztai L, Theriault R, Adinin R, Hofweber M, Fukushima M, Mita A, Bindra N, Hortobagyi G. Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC). Journal Of Clinical Oncology 2006, 24: 10576-10576. DOI: 10.1200/jco.2006.24.18_suppl.10576.Peer-Reviewed Original ResearchMetastatic breast cancerPhase II doseBID days 1TAS-102Dose levelsBreast cancerDay 1Grade 3 non-hematologic toxicityEvaluable metastatic breast cancerInitial starting doseNon-hematologic toxicitiesInitial dose levelAdditional dose levelsHighest dose levelEvaluation of responseMinimal alopeciaHematologic toxicityStarting doseDaily dosingStandard therapyOral combinationStudy doseClinical activityOral administrationGrade 3Bortezomib (VELCADE®) in metastatic breast cancer: pharmacodynamics, biological effects, and prediction of clinical benefits
Yang CH, Gonzalez-Angulo AM, Reuben JM, Booser DJ, Pusztai L, Krishnamurthy S, Esseltine D, Stec J, Broglio KR, Islam R, Hortobagyi GN, Cristofanilli M. Bortezomib (VELCADE®) in metastatic breast cancer: pharmacodynamics, biological effects, and prediction of clinical benefits. Annals Of Oncology 2006, 17: 813-817. PMID: 16403809, DOI: 10.1093/annonc/mdj131.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBone NeoplasmsBoronic AcidsBortezomibBreast NeoplasmsDisease ProgressionDisease-Free SurvivalFemaleHumansMaleMaximum Tolerated DoseMiddle AgedPleural NeoplasmsProtease InhibitorsPyrazinesReceptors, EstrogenReceptors, ProgesteroneSoft Tissue NeoplasmsSurvival RateTreatment OutcomeConceptsMetastatic breast cancerBreast cancerPlasma interleukin-6 levelsCommon grade 3Limited clinical activityClinical response ratePhase II studyInterleukin-6 levelsMedian survival timeWeek of restBroad antitumor activityStable diseaseII studyObjective responseSkin rashClinical effectsClinical benefitDisease progressionClinical activityGrade 3Pharmacodynamic dataSurvival timeMean inhibitionSingle agentResponse rate