Testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer (ENZAMET): an international, open-label, randomised, phase 3 trial

Martin, Andrew; Cheung, Leanna; Lawrence, Nicola; McJannett, Margaret; Parulekar, Wendy R.; Reaume, M. Neil; Tan, Thean Hsiang; Vera‐Badillo, Francisco; Williams, Scott; Winter, Diana; Yip, Sonia; Zhang, Alison; Abdi, Ehtesham; Allan, Suzanne; Bastick, Patricia; Begbie, Stephen; Blum, Robert; Briscoe, Karen; Brungs, Daniel; Bydder, Sean; Chittajallu, Bala Renuka; Cronk, Michelle R.; Cuff, Katharine; Davis, Ian D.; Dowling, Anthony; Frydenberg, Mark; George, M. C.; Horvath, Lisa G.; Hovey, Elizabeth; Joshua, Anthony M.; Karanth, Narayan; Kichenadasse, Ganessan; Krieger, Laurence E.; Marx, Gavin; Mathlum, Maitham; Nott, Louise M.; Otty, Zulfiquer; Parnis, Francis; Pook, David; Sandhu, Shahneen; Sewak, Sanjeev; Stevanovic, Amanda Gwendolyn; Stockler, Martin R.; Suder, Aneta; Tan, Hsiang; Torres, Javier; Troon, Simon; Underhill, Craig; Weickhardt, Andrew; Zielinski, Robert; Abbas, Tahir; Anan, Ghadeer; Booth, C. N.; Campbell, H. E. A.; N., Kim; Chin, Joseph L.; Chouinard, Edmond; Donnelly, Bryan J.; Drachenberg, Darrel; Faghih, Amir; Finelli, Antonio; Hotte, Sébastien J.; Noonan, Krista; North, Scott; Rassouli, Mohammad; Reaume, N.; Rendon, Ricardo; Saad, Fred; Sadikov, Evgeny; Vigneault, Éric; Zalewski, Paweł; McCaffrey, John; McDermott, Ray; Morris, Patrick G.; O’Connor, Miriam; Donnellan, Paul; O’Donnell, Dearbhaile M.; Edwards, Joanne; Fong, Peter; Tan, Alvin; Chowdhury, Simon; Crabb, Simon J.; Khan, Omar; Khoo, Vincent; Macdonald, Graham; Payne, Heather; Robinson, Angus; Shamash, Jonathon; Staffurth, John; Thomas, C.; Thomson, Alastair; Sweeney, Christopher J.

doi:10.1016/s1470-2045(23)00063-3

Cited by 64 publications

(46 citation statements)

References 21 publications

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“…Long‐term follow‐up of the ENZAMET (Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer) trial shows sustained improved overall survival for men with metastatic hormone‐sensitive prostate cancer treated with the addition of enzalutamide (ENZA) to testosterone suppression 1 . The results confirm the short‐term improved survival benefits seen in an interim analysis.…”

mentioning

confidence: 58%

Enzalutamide shows sustained overall survival improvement in patients with metastatic hormone‐sensitive prostate cancer

Nierengarten¹

2023

Cancer

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mentioning

confidence: 58%

Enzalutamide shows sustained overall survival improvement in patients with metastatic hormone‐sensitive prostate cancer

Nierengarten¹

2023

Cancer

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“…The primary outcome of ENZAMET was OS and was stratified by docetaxel use. The most recent results after a median follow-up of 68 months (476 deaths) showed ongoing OS improvements in the overall cohort (5-year OS 67% vs. 57%, HR 0.70, p < 0.001) [ 21 , 34 ]. The benefit of enzalutamide was less pronounced in patients who received docetaxel (HR 0.82 (0.63–1.06); however, the use of docetaxel did not result in a significant interaction with the overall benefit of enzalutamide across the disease spectrum.…”

Section: Triplet Therapy In Mcspc—rationale and Summary Of Clinical Datamentioning

confidence: 99%

Triplet Therapy in Metastatic Castrate Sensitive Prostate Cancer (mCSPC)—A Potential New Standard of Care

et al. 2023

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The treatment paradigm for metastatic castrate-sensitive prostate cancer (mCSPC) has evolved rapidly in the past decade with the approval of several life-prolonging therapies including docetaxel chemotherapy and multiple androgen receptor pathway inhibitors (ARPI) in combination with androgen deprivation therapy (ADT). Recently reported phase-three trials have demonstrated a survival benefit of upfront triplet therapy with ADT, docetaxel plus either abiraterone acetate or darolutamide when compared to ADT plus docetaxel alone. However, multiple questions including the incremental benefit of docetaxel to a combination of ADT and ARPI, the timing of ARPI, optimal patient selection for triplet therapy and clinical and genomic biomarkers still remain to be answered. Moreover, real-world data suggest suboptimal treatment intensification with many patients treated with ADT alone highlighting challenges in implementation. In this article, we review the phase-three data associated with triplet therapy in mCSPC. We also discuss the knowledge gaps that exist despite the completion of these studies and how ongoing studies are likely to change the paradigm in the near future. Finally, we provide a simple algorithm based on current data that clinicians can use in daily practice to select patients for appropriate treatment strategies.

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“…Nach einem medianen FU von 34 Monaten betrug die HR zugunsten des Enzalutamid-Armes 0,67 (KI 0,52-0,86; p = 0,002) [13]. Nach einem medianen FU von 68 Monaten ist das mediane OS noch immer nicht erreicht gewesen (HR 0,70; KI 0,58-0,84; p<0,0001) [14].…”

Section: Enzalutamid -Enzamet Und Archesunclassified

“…Die ENZAMET-und TITAN-Studie, welche eine Therapie mit Enzalutamid bzw. Apalutamid evaluierten, enthielten ein ausgewogenes Patientengut im Hinblick auf die Metastasenlast [14,18]. Im Hinblick auf den Zeitpunkt der Metastasierung waren die Patienten in der TITAN-Studie jedoch nicht ausgeglichen verteilt, da auch hier nur ein geringer Anteil der Patienten metachron metastasiert waren (16%) [18].…”

Section: Evaluation Von Metastasierungsmuster Und -Zeitpunktunclassified

“…Im Hinblick auf den Zeitpunkt der Metastasierung waren die Patienten in der TITAN-Studie jedoch nicht ausgeglichen verteilt, da auch hier nur ein geringer Anteil der Patienten metachron metastasiert waren (16%) [18]. In der ENZA-MET-Studie war dieses Patientenkollektiv hingegen in 42% vertreten [14]. Die ARASENS-Studie inkludierte alle Patienten, wohin gegen die PEACE-1-Studie nur de novo metastasierte Patienten enthielt [23,25].…”

Section: Evaluation Von Metastasierungsmuster Und -Zeitpunktunclassified

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Medikamentöse Tumortherapie des mHSPC: Double- oder Tripletherapie: wer, wann und wie?

Paffenholz,

Roesch

2023

Aktuelle Urol

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Zusammenfassung Die alleinige Androgendeprivation (ADT) zur Therapie des metastasierten hormonsensitiven Prostatakarzinoms (mHSPC) stellt mittlerweile eine Ausnahme dar. Die derzeitige Standardtherapie des mHSPC besteht aus einer Kombination: entweder ADT + neuartigen Hormontherapie (NHT) oder ADT + Chemotherapie. Aufgrund neuester Studiendaten und einer entsprechenden Zulassung (in Deutschland) nimmt die dreifache Kombination bestehend aus ADT + NHT + Chemotherapie Einzug in die Therapie des mHSPC. Die komplexer werdende mHSPC-Therapie erfordert die prätherapeutische Einteilung in ein „low“ vs. „high risk“, „low“ vs. „high volume“ und synchron vs. metachron metastasiertes HSPC. Zudem muss das Nebenwirkungsprofil der einzelnen Optionen beachtet und insbesondere eingeschätzt werden, ob der Patient Chemotherapie-fit vs. -unfit ist. Diese Übersicht gibt einen prägnanten Überblick über die relevanten Studien sowie die entsprechenden derzeit gültigen Empfehlungen und Zulassungen für Deutschland.

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Testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer (ENZAMET): an international, open-label, randomised, phase 3 trial

Cited by 64 publications

References 21 publications

Enzalutamide shows sustained overall survival improvement in patients with metastatic hormone‐sensitive prostate cancer

Enzalutamide shows sustained overall survival improvement in patients with metastatic hormone‐sensitive prostate cancer

Triplet Therapy in Metastatic Castrate Sensitive Prostate Cancer (mCSPC)—A Potential New Standard of Care

Medikamentöse Tumortherapie des mHSPC: Double- oder Tripletherapie: wer, wann und wie?

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