Predictors of treatment (tx) duration in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) treated with enzalutamide (ENZA): A post hoc analysis of ARCHES.
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Le résumé fourni par la source
5093 Background: In ARCHES (NCT02677896), ENZA + androgen-deprivation therapy (ADT) significantly improved radiographic progression-free survival (primary: data cutoff, Oct 14, 2018) and overall survival (prespecified secondary: data cutoff, May 28, 2021; 5-year follow-up: data cutoff, Jul 31, 2024) vs placebo + ADT in mHSPC. This post hoc analysis explored factors associated with different ENZA tx durations (5-year follow-up). Methods: Reasons for tx discontinuation (DC) including toxicity and progression, and baseline and on-treatment factors underlying tx persistence, were compared descriptively among pts with short (0–2 years [y]; STx), medium (2–5 y; MTx), and long Tx duration (> 5 y; LTx) (STx pts represent non-responders; MTx/LTx pts represent tx responders). Results: Of 572 ENZA-treated pts, 204 (36%) were STx; 140 (24%) MTx; 228 (40%) LTx. STx pts were more likely to be older vs MTx and LTx, with high-volume disease (HVD) and Eastern Cooperative Oncology Group performance status (ECOG PS) 1, although 55.3% of LTx had HVD and 73.2% had synchronous metastases. Progressive disease and tx-emergent adverse events (TEAEs) were the most common reasons for tx DC. Drug-related TEAEs (per 100 pt-y) were more common in STx (156.0) vs MTx (89.5) and LTx (47.1), as were those leading to tx DC (STx: 12.4; MTx: 1.5; LTx: 0.1). Rates (per 100 pt-y) of TEAEs leading to ENZA dose reduction were higher in STx (6.2) vs MTx (5.8) and LTx (2.0). The rate (per 100 pt-y) of drug-related TEAEs of special interest were generally higher in STx vs MTx and LTx: convulsions (1.0 vs 0.0 vs 0.0); fatigue (19.0 vs 10.7 vs 4.8), select cardiovascular events (1.0 vs 0.6 vs 0.1); falls (2.4 vs 3.2 vs 1.1); fractures (0.5 vs 1.5 vs 0.5). Conclusions: Our findings demonstrate that LTx and MTx tended to have more favorable pt and disease characteristics vs STx, although majority of LTx had adverse prognostic features. While progressive disease was the most common reason for DC, AEs/withdrawals were the second most common. Most TEAEs of special interest were more frequent in STx. Reasons for AE-related tx changes are multifactorial, and optimal management of AEs and comorbidities, as well as dose modifications, can optimize ENZA tx. Clinical trial information: NCT02677896 . Pt characteristics STx (n = 204)n (%) MTx (n = 140)n (%) LTx (n = 228)n (%) Age: ≥ 18 to 64/≥ 65 to ≤ 84/≥ 85 y 45 (22.1)/150 (73.5)/9 (4.4) 38 (27.1)/100 (71.4)/2 (1.4) 65 (28.5)/159 (69.7)/4 (1.8) Prostate-specific antigen nadir < 0.2 ng/mL post-baseline 84/189 (44.4) 97/123 (78.9) 181/198 (91.4) ECOG PS 0/1 147 (72.1)/57 (27.9) 110 (78.6)/30 (21.4) 190 (83.3)/37 (16.2) HVD 148 (72.5) 80 (57.1) 126 (55.3) Synchronous disease 162 (79.4) 108 (77.1) 167 (73.2) Reasons for tx DC Progressive disease 106 (52.0) 63 (45.0) 19 (8.3) AE + withdrawalAEWithdrawal 74 (36.3)40 (19.6)34 (16.7) 40 (28.6)25 (17.9)15 (10.7) 7 (3.1)2 (0.9)5 (2.2) Death 10 (4.9) 10 (7.1) 10 (4.4)
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Predictors of treatment (tx) duration in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) treated with enzalutamide (ENZA): A post hoc analysis of ARCHES.
- Date Crossref
- 01/06/2026
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Prostate Cancer UK pays non établi dans la noticeOrganisation à but non lucratif
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Yale University pays non établi dans la noticeUniversité ou école supérieure
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Carolina Urologic Research Center pays non établi dans la noticeStructure de recherche
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University of Chicago Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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University of Kansas Medical Center pays non établi dans la noticeOrganisme public
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Université de Lille pays non établi dans la noticeUniversité ou école supérieure
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Hospital Clínic de Barcelona Department of Urology pays non établi dans la noticeÉtablissement de santé
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P.A. Hertzen Moscow Oncology Research Institute pays non établi dans la noticeStructure de recherche
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Kanazawa Medical University pays non établi dans la noticeUniversité ou école supérieure
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Complexo Hospitalario Universitario A Coruña pays non établi dans la noticeÉtablissement de santé
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Astellas Pharma (United States) pays non établi dans la noticeEntreprise
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Pfizer (United States) pays non établi dans la noticeEntreprise
Prostate Cancer UK, Yale University et Carolina Urologic Research Center, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.