2023
FORMULA-509: A Multicenter Randomized Trial of Post-Operative Salvage Radiotherapy (SRT) and 6 Months of GnRH Agonist with Either Bicalutamide or Abiraterone Acetate/Prednisone (AAP) and Apalutamide (Apa) Post-Radical Prostatectomy (RP)
Nguyen P, Kollmeier M, Rathkopf D, Hoffman K, Zurita-Saavedra A, Spratt D, Dess R, Liauw S, Szmulewitz R, Einstein D, Bubley G, Yu J, An Y, Wong A, Feng F, Mckay R, Rose B, Shin K, Kibel A, Taplin M. FORMULA-509: A Multicenter Randomized Trial of Post-Operative Salvage Radiotherapy (SRT) and 6 Months of GnRH Agonist with Either Bicalutamide or Abiraterone Acetate/Prednisone (AAP) and Apalutamide (Apa) Post-Radical Prostatectomy (RP). International Journal Of Radiation Oncology • Biology • Physics 2023, 117: s81-s82. DOI: 10.1016/j.ijrobp.2023.06.401.Peer-Reviewed Original ResearchPSA progression-free survivalMetastasis-free survivalMonths of GnRH agonistAbiraterone acetate/prednisoneSalvage radiotherapyGnRH agonistPre-planned analysisPost-RPStratification factorsProgression-free survivalPost-radical prostatectomyMedian Follow-UpSubgroup of patientsMulticenter randomized trialOne-sided type I errorPre-planned subgroup analysisStatistically significant benefitTwo-sided p-valuePelvic nodesOpen-labelPrimary endpointSecondary endpointsInvestigator-initiatedSafety profileAdverse eventsFORMULA-509: A multicenter randomized trial of post-operative salvage radiotherapy (SRT) and 6 months of GnRH agonist with or without abiraterone acetate/prednisone (AAP) and apalutamide (Apa) post-radical prostatectomy (RP).
Nguyen P, Kollmeier M, Rathkopf D, Hoffman K, Zurita A, Spratt D, Dess R, Liauw S, Szmulewitz R, Einstein D, Bubley G, Yu J, An Y, Wong A, Feng F, McKay R, Rose B, Shin K, Kibel A, Taplin M. FORMULA-509: A multicenter randomized trial of post-operative salvage radiotherapy (SRT) and 6 months of GnRH agonist with or without abiraterone acetate/prednisone (AAP) and apalutamide (Apa) post-radical prostatectomy (RP). Journal Of Clinical Oncology 2023, 41: 303-303. DOI: 10.1200/jco.2023.41.6_suppl.303.Peer-Reviewed Original ResearchPSA progression-free survivalMetastasis-free survivalMonths of GnRH agonistAbiraterone acetate/prednisoneSalvage radiotherapyPre-planned analysisGnRH agonistPost-RPStratification factorsProgression-free survivalPost-radical prostatectomyMedian Follow-UpMonths of ADTSubgroup of patientsMulticenter randomized trialOne-sided type I errorPre-planned subgroup analysisStatistically significant benefitPelvic nodesOpen-labelPrimary endpointSecondary endpointsInvestigator-initiatedSafety profileAdverse events
2009
Dose-Dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel (P) with Trastuzumab (T) and Lapatinib (L) in Early Breast Cancer (EBC); Troponin I and C-Reactive Protein as Biomarkers of Cardiotoxicity.
Morris P, Chen C, Lin N, Moy B, Come S, Abbruzzi A, Patil S, Winer E, Norton L, Hudis C, Dang C. Dose-Dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel (P) with Trastuzumab (T) and Lapatinib (L) in Early Breast Cancer (EBC); Troponin I and C-Reactive Protein as Biomarkers of Cardiotoxicity. Cancer Research 2009, 69: 3088-3088. DOI: 10.1158/0008-5472.sabcs-09-3088.Peer-Reviewed Original ResearchLeft ventricular ejection fractionCongestive heart failureC-reactive proteinEarly breast cancerBiomarkers of cardiotoxicityMinimal elevationEvidence of CHFElevated C-reactive proteinTroponin IDose-dense doxorubicinSensitive inflammatory markerAnti-HER2 agentsVentricular ejection fractionPre-planned analysisCardiac troponin IElevated TnIUncontrolled arrhythmiaWeekly paclitaxelInflammatory markersMUGA scanUnstable anginaEjection fractionHeart failureRecent MIProspective study
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