2023
The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES
Armstrong A, Iguchi T, Azad A, Villers A, Alekseev B, Petrylak D, Szmulewitz R, Alcaraz A, Shore N, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas G, Gourgiotti G, El-Chaar N, Stenzl A. The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES. European Urology 2023, 84: 229-241. PMID: 37179240, DOI: 10.1016/j.eururo.2023.04.002.Peer-Reviewed Original ResearchConceptsHormone-sensitive prostate cancerAndrogen deprivation therapyRadiographic progression-free survivalMetastatic hormone-sensitive prostate cancerOligometastatic hormone-sensitive prostate cancerOverall survivalProstate cancerDeprivation therapyHazard ratioAndrogen receptor inhibitionEarly treatment intensificationEfficacy of enzalutamideRisk of undertreatmentSystemic treatment strategiesSecondary efficacy endpointsPhase 3 studyProgression-free survivalNumber of metastasesConfidence intervalsProportional hazards modelPost Hoc AnalysisEfficacy endpointOligometastatic diseaseSecondary endpointsTreatment intensification
2021
The efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) on bone oligometastatic hormone-sensitive prostate cancer: A post hoc analysis of ARCHES.
Armstrong A, Iguchi T, Azad A, Villers A, Alekseev B, Petrylak D, Szmulewitz R, Alcaraz A, Shore N, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas G, Gourgioti G, El-Chaar N, Stenzl A. The efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) on bone oligometastatic hormone-sensitive prostate cancer: A post hoc analysis of ARCHES. Journal Of Clinical Oncology 2021, 39: 5071-5071. DOI: 10.1200/jco.2021.39.15_suppl.5071.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyEfficacy of enzalutamideHormone-sensitive prostate cancerBone metastasesTreatment armsProstate cancerOligometastatic hormone-sensitive prostate cancerPrior docetaxel chemotherapySecondary clinical outcomesDeprivation therapyEfficacy outcomesRadiographic progressionSecondary endpointsBaseline characteristicsDisease volumeDocetaxel chemotherapyMetastatic burdenPolymetastatic diseaseArch studyClinical outcomesCentral reviewClinical benefitSafety profilePlaceboEfficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial.
Azad A, Villers A, Alekseev B, Szmulewitz R, Alcaraz A, Shore N, Petrylak D, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Lee H, Haas G, Iguchi T, Stenzl A, Armstrong A. Efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial. Journal Of Clinical Oncology 2021, 39: 102-102. DOI: 10.1200/jco.2021.39.6_suppl.102.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerEfficacy of enzalutamideAndrogen deprivation therapyDe novo metastatic hormone-sensitive prostate cancerM1 diseaseInitial diagnosisProstate-specific antigenSecondary endpointsDisease volumeTreatment armsHormone-sensitive prostate cancerProgression-free survival eventsPrior docetaxel useKey secondary endpointNew antineoplastic therapiesDeprivation therapyDocetaxel usePrior docetaxelEfficacy outcomesPrimary endpointPSA progressionBaseline characteristicsObjective responseClinical benefitSafety profile
2020
Efficacy of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) by pattern of metastatic spread: ARCHES post hoc analyses.
Shore N, Armstrong A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Lee H, Haas G, Stenzl A. Efficacy of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) by pattern of metastatic spread: ARCHES post hoc analyses. Journal Of Clinical Oncology 2020, 38: 5547-5547. DOI: 10.1200/jco.2020.38.15_suppl.5547.Peer-Reviewed Original ResearchRadiographic progression-free survivalEfficacy of enzalutamideAndrogen deprivation therapyMetastatic hormone-sensitive prostate cancerSymptomatic skeletal eventsSoft tissue metastasesMetastatic spreadVisceral metastasesSecondary endpointsBone metastasesFirst symptomatic skeletal eventHormone-sensitive prostate cancerProstate-specific antigen progressionLarge patient subgroupPrior docetaxel treatmentProgression-free survivalSecondary endpoint measuresGreater relative efficacyNew antineoplastic therapiesM0 patientsDeprivation therapyPrimary endpointSkeletal eventsCastration resistanceDisease volume
2019
ARCHES: Efficacy of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC).
Armstrong A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Baron B, Chen L, Stenzl A. ARCHES: Efficacy of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC). Journal Of Clinical Oncology 2019, 37: 5048-5048. DOI: 10.1200/jco.2019.37.15_suppl.5048.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyCastration-resistant prostate cancerAdverse eventsSecondary endpointsOverall survivalProstate cancerNonmetastatic castration-resistant prostate cancerHormone-sensitive prostate cancerPrior androgen deprivation therapyRadiographic progression-free survivalEfficacy of enzalutamideHigh-volume diseasePrior docetaxel usePrior treatment subgroupsPre-specified subgroupsProgression-free survivalPhase 3 studyUnexpected adverse eventsNew antineoplastic therapiesDocetaxel useDeprivation therapyEfficacy endpointPrimary endpointPrior therapyPhase III study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): The ARCHES trial.
Armstrong A, Szmulewitz R, Petrylak D, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. Phase III study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): The ARCHES trial. Journal Of Clinical Oncology 2019, 37: 687-687. DOI: 10.1200/jco.2019.37.7_suppl.687.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerRadiographic progression-free survivalAndrogen deprivation therapyCastration-resistant prostate cancerAdverse eventsPrior docetaxelSecondary endpointsDisease volumeOverall survivalProstate cancerNonmetastatic castration-resistant prostate cancerHormone-sensitive prostate cancerProstate-specific antigen progressionEfficacy of enzalutamideHigh-volume diseasePhase 3 studyProgression-free survivalAndrogen receptor inhibitorUnexpected adverse eventsSimilar significant improvementsDeprivation therapyEfficacy endpointPrimary endpointTreatment discontinuationBaseline characteristics