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
2022
1398P Overall survival (OS) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) who received prior androgen deprivation therapy (ADT) and reached low prostate-specific antigen (PSA) levels treated further with enzalutamide (ENZA): Post hoc analyses of ARCHES
Petrylak D, Azad A, Szmulewitz R, Iguchi T, Shore N, Holzbeierlein J, Alekseev B, El-Chaar N, Rosbrook B, Ma J, Zohren F, Haas G, Stenzl A, Armstrong A. 1398P Overall survival (OS) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) who received prior androgen deprivation therapy (ADT) and reached low prostate-specific antigen (PSA) levels treated further with enzalutamide (ENZA): Post hoc analyses of ARCHES. Annals Of Oncology 2022, 33: s1183-s1184. DOI: 10.1016/j.annonc.2022.07.1884.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyOverall survivalLow prostate-specific antigen levelsHormone-sensitive prostate cancerPrior androgen deprivation therapyProstate-specific antigen levelDeprivation therapyAntigen levelsProstate cancerEnzalutamidePatientsTherapyCancerA0517 Clinical outcomes of patients with metastatic Hormone-Sensitive Prostate Cancer (mHSPC) with Prostate-Specific Antigen (PSA) decline to undetectable levels on enzalutamide (ENZA): Post hoc analysis of ARCHES
Stenzl A, Shore N, Villers A, Iguchi T, Gomez-Veiga F, Alcaraz A, Alekseev B, Azad A, Szmulewitz R, Petrylak D, Holzbeierlein J, Rosbrook B, Zohren F, Haas G, Gourgioti G, El-Chaar N, Armstrong A. A0517 Clinical outcomes of patients with metastatic Hormone-Sensitive Prostate Cancer (mHSPC) with Prostate-Specific Antigen (PSA) decline to undetectable levels on enzalutamide (ENZA): Post hoc analysis of ARCHES. European Urology 2022, 81: s776-s777. DOI: 10.1016/s0302-2838(22)00600-5.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerHormone-sensitive prostate cancerProstate-specific antigen (PSA) declineClinical outcomesProstate cancerUndetectable levelsPatientsCancer
2021
LBA25 Final overall survival (OS) analysis from ARCHES: A phase III, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Armstrong A, Iguchi T, Azad A, Szmulewitz R, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Shore N, Petrylak D, Rosbrook B, Zohren F, Yamada S, Haas G, Stenzl A. LBA25 Final overall survival (OS) analysis from ARCHES: A phase III, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). Annals Of Oncology 2021, 32: s1300-s1301. DOI: 10.1016/j.annonc.2021.08.2101.Peer-Reviewed Original ResearchThe 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
ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of efficacy by baseline prostate-specific antigen (PSA) levels
Alcaraz A, Szmulewitz R, Shore N, Crawford E, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Sugg J, Haas G, Stenzl A, Armstrong A. ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of efficacy by baseline prostate-specific antigen (PSA) levels. Annals Of Oncology 2020, 31: s523-s524. DOI: 10.1016/j.annonc.2020.08.894.Peer-Reviewed Original Research557 ARCHES: Efficacy of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC) by prior local and systemic treatment
Stenzl A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Gomez-Veiga F, Rosbrook B, Baron B, Haas G, Armstrong A. 557 ARCHES: Efficacy of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC) by prior local and systemic treatment. European Urology Open Science 2020, 19: e865-e866. DOI: 10.1016/s2666-1683(20)33160-8.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyHormone-sensitive prostate cancerDeprivation therapySystemic treatmentProstate cancerPlaceboEnzalutamideTherapyCancerEfficacy 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 volumePD10-10 IMPACT OF BASELINE DISEASE VOLUME AND PRIOR DOCETAXEL THERAPY ON PROSTATE-SPECIFIC ANTIGEN-RELATED OUTCOMES IN PATIENTS WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER TREATED WITH ENZALUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY
Shore* N, Crawford E, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Baron B, Haas G, Stenzl A, Armstrong A. PD10-10 IMPACT OF BASELINE DISEASE VOLUME AND PRIOR DOCETAXEL THERAPY ON PROSTATE-SPECIFIC ANTIGEN-RELATED OUTCOMES IN PATIENTS WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER TREATED WITH ENZALUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY. Journal Of Urology 2020, 203 DOI: 10.1097/ju.0000000000000844.010.Peer-Reviewed Original Research
2019
853P ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups
Stenzl A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Baron B, Haas G, Morlock R, Ramaswamy K, Armstrong A. 853P ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups. Annals Of Oncology 2019, 30: v332-v333. DOI: 10.1093/annonc/mdz248.010.Peer-Reviewed Original ResearchRadiographic progression-free survivalAndrogen deprivation therapyMetastatic hormone-sensitive prostate cancerCastration-resistant prostate cancerSymptomatic skeletal eventsProgression-free survivalDisease volumeOverall survivalRisk groupsAdverse eventsQuality of lifeAstellas PharmaBristol-Myers SquibbDeprivation therapyVisceral metastasesSkeletal eventsRadiographic responseTrial criteriaBone lesionsProstate cancerHigher QoLHormone-sensitive prostate cancerProstate-specific antigen progressionAstellas Pharma Inc.Genentech/RocheSC170 Phase 3 study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (MHSPC): The ARCHES trial
Basso U, Galetti T, 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. SC170 Phase 3 study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (MHSPC): The ARCHES trial. European Urology Open Science 2019, 18: e3258. DOI: 10.1016/s1569-9056(19)33650-4.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyHormone-sensitive prostate cancerPhase 3 studyDeprivation therapyProstate cancerPlaceboEnzalutamideTherapyCancerTrialsARCHES: 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 therapyLBA-10 ARCHES – EFFICACY OF ANDROGEN DEPRIVATION THERAPY WITH ENZALUTAMIDE OR PLACEBO IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER: PROSTATE-SPECIFIC ANTIGEN RESULTS
Stenzl* A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Baron B, Kunieda F, Morlock R, Ramaswamy K, Armstrong A. LBA-10 ARCHES – EFFICACY OF ANDROGEN DEPRIVATION THERAPY WITH ENZALUTAMIDE OR PLACEBO IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER: PROSTATE-SPECIFIC ANTIGEN RESULTS. Journal Of Urology 2019, 201 DOI: 10.1097/01.ju.0000557502.92839.76.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerHormone-sensitive prostate cancerProstate-specific antigen resultsAndrogen deprivation therapyDeprivation therapyProstate cancerAntigen resultsEnzalutamideTherapyCancerPhase 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