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
2020
Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial
Goldberg SB, Schalper KA, Gettinger SN, Mahajan A, Herbst RS, Chiang AC, Lilenbaum R, Wilson FH, Omay SB, Yu JB, Jilaveanu L, Tran T, Pavlik K, Rowen E, Gerrish H, Komlo A, Gupta R, Wyatt H, Ribeiro M, Kluger Y, Zhou G, Wei W, Chiang VL, Kluger HM. Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial. The Lancet Oncology 2020, 21: 655-663. PMID: 32251621, PMCID: PMC7380514, DOI: 10.1016/s1470-2045(20)30111-x.Peer-Reviewed Original ResearchConceptsBrain metastasis responseYale Cancer CenterPD-L1 expressionPhase 2 trialUntreated brain metastasesBrain metastasesAdrenal insufficiencyAdverse eventsMetastasis responseCNS diseaseCancer CenterCohort 2Cohort 1Eastern Cooperative Oncology Group performance statusTreatment-related serious adverse eventsModified Response Evaluation CriteriaStage IV NSCLCTreatment-related deathsAcute kidney injuryPD-1 blockadeSerious adverse eventsSolid Tumors criteriaPhase 2 studyProportion of patientsResponse Evaluation Criteria