2004
Efficacy and safety of liposomal anthracyclines in Phase I/II clinical trials
Alberts DS, Muggia FM, Carmichael J, Winer EP, Jahanzeb M, Venook AP, Skubitz KM, Rivera E, Sparano JA, Dibella NJ, Stewart SJ, Kavanagh JJ, Gabizon AA. Efficacy and safety of liposomal anthracyclines in Phase I/II clinical trials. Seminars In Oncology 2004, 31: 53-90. PMID: 15717738, DOI: 10.1053/j.seminoncol.2004.08.010.Peer-Reviewed Original ResearchConceptsLiposomal anthracyclinesClinical trialsConventional anthracyclinesLiposomal doxorubicinTumor typesPhase I/II clinical trialsSingle-agent therapyRange of dosesAnthracycline therapyLiposomal daunorubicinAnthracycline treatmentPharmacologic advantageContinuous infusionPatient populationHematologic tumorsClinical dataPreclinical studiesPharmacokinetic profileAnthracyclinesDrug concentrationsCytotoxic agentsTumor cellsPhase ITrialsFurther studiesThe role of the liposomal anthracyclines and other systemic therapies in the management of advanced breast cancer
Robert NJ, Vogel CL, Henderson IC, Sparano JA, Moore MR, Silverman P, Overmoyer BA, Shapiro CL, Park JW, Colbern GT, Winer EP, Gabizon AA. The role of the liposomal anthracyclines and other systemic therapies in the management of advanced breast cancer. Seminars In Oncology 2004, 31: 106-146. PMID: 15717740, DOI: 10.1053/j.seminoncol.2004.09.018.Peer-Reviewed Original ResearchConceptsConventional doxorubicinBreast cancerLiposomal anthracyclinesLiposomal doxorubicinHand-foot syndromeAdvanced breast cancerMultiple phase IIConventional anthracyclinesSystemic therapyProlong survivalStandard dosesContinuous infusionToxicity profileOptimal doseActive drugCytotoxic drugsHigh dosesIntermittent scheduleWeekly scheduleAnthracyclinesNormal tissuesTrastuzumabCancerDoxorubicinNausea
1996
Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer.
Chu L, Sutton LM, Peterson BL, Havlin KA, Winer EP. Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer. The Journal Of Infusional Chemotherapy 1996, 6: 211-6. PMID: 9229318.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSymptom Distress ScaleFunctional Living Index-CancerFirst-line settingFirst-line therapyBreast cancerContinuous infusionDisease progressionPrevious phase II studyRefractory metastatic breast cancerAdequate bone marrowContinuous infusion fluorouracilGrade 3 mucositisECOG performance statusMedian overall survivalObjective response ratePhase II studyContinuous intravenous infusionQuality of lifeEvaluable diseaseFLIC scoresInfusion fluorouracilMeasurable diseasePrior chemotherapyIndex cancer
1992
High-Dose Oral Tamoxifen, a Potential Multidrug-Resistance-Reversal Agent: Phase I Trial in Combination With Vinblastine
Trump DL, Smith DC, Ellis PG, Rogers MP, Schold SC, Winer EP, Panella TJ, Jordan VC, Fine RL. High-Dose Oral Tamoxifen, a Potential Multidrug-Resistance-Reversal Agent: Phase I Trial in Combination With Vinblastine. Journal Of The National Cancer Institute 1992, 84: 1811-1816. PMID: 1359155, DOI: 10.1093/jnci/84.23.1811.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsATP Binding Cassette Transporter, Subfamily B, Member 1Drug Administration ScheduleDrug ResistanceFemaleHumansInfusions, IntravenousMaleMembrane GlycoproteinsMiddle AgedNeoplasm ProteinsNeoplasmsTamoxifenVinblastineConceptsLoading doseN-desmethyltamoxifenOral tamoxifenContinuous infusionPlasma concentrationsHigh-dose oral tamoxifenDose-limiting toxic effectPhase I clinical trialAdvanced epithelial tumorsHigh-dose tamoxifenTriphenylethylene antiestrogen tamoxifenPhase II trialDose-limiting toxicityPhase I trialDoses of tamoxifenStart of treatmentP-glycoprotein functionToxicity of vinblastineAnti-neoplastic agentsToxic effectsMetabolite N-desmethyltamoxifenIntracellular concentrationAsymptomatic prolongationStarting doseII trial