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
2009
A Phase II Study of Flavopiridol (Alvocidib) in Combination with Docetaxel in Refractory, Metastatic Pancreatic Cancer
Carvajal RD, Tse A, Shah MA, Lefkowitz RA, Gonen M, Gilman-Rosen L, Kortmansky J, Kelsen DP, Schwartz GK, O'Reilly E. A Phase II Study of Flavopiridol (Alvocidib) in Combination with Docetaxel in Refractory, Metastatic Pancreatic Cancer. Pancreatology 2009, 9: 404-409. PMID: 19451750, PMCID: PMC4053191, DOI: 10.1159/000187135.Peer-Reviewed Original ResearchConceptsPhase II studyPancreatic adenocarcinomaII studyRisk/benefit equationGrade 3 diarrheaGrade 3 fatigueTransient stable diseaseGrade 4 neutropeniaMetastatic pancreatic adenocarcinomaMetastatic pancreatic cancerCombination of flavopiridolCell cycle dysregulationPrimary endpointStable diseaseMedian survivalObjective responseAdverse eventsPatient populationTumor sizePan-cyclinPancreatic cancerClinical activityTumor measurementsDose reductionPatients