Abstract B131: Efficacy and safety of darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel in Black/African-American patients from the phase 3 ARASENS trial
Notice bibliographique
Résumé
Abstract Introduction: Blacks/African-Americans (B/AAs) are disproportionately affected by prostate cancer, with higher incidence and mortality rates versus other racial/ethnic groups. Darolutamide (DARO) is a structurally distinct and highly potent androgen receptor inhibitor. In the ARASENS trial (NCT02799602), DARO in combination with androgen-deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% (HR, 0.68; 95% CI 0.57–0.80; P<0.001) vs placebo (PBO) + ADT with docetaxel in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC). We present efficacy and safety of DARO + ADT and docetaxel in B/AAs from ARASENS. Methods: Pts with mHSPC were randomized 1:1 to DARO 600 mg or PBO twice daily in combination with ADT and docetaxel. The primary endpoint was overall survival (OS). Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and safety. Results: In ARASENS, 54 B/AAs received DARO (n=26) or PBO (n=28); 36/244 (14.8%) patients recruited in North America were B/AA. Baseline characteristics in the B/AA population were generally similar compared with the overall population, except for the proportion of pts who were <65 years of age (57.4% vs 36.6%), had ECOG performance status of 1 (37.0% vs 28.7%) and recurrent disease (24.1% vs 12.9%). Median prostate-specific antigen levels were similar (35.9 vs 27.6 μg/L), but alkaline phosphatase levels were lower in B/AAs (109.5 vs 143.0 U/L) vs all patients. In B/AAs, OS favored DARO + ADT + docetaxel vs PBO + ADT + docetaxel (stratified HR, 0.41; 95% CI, 0.17–1.02), with 4-year survival rates of 62% vs 41%. The DARO group also had longer time to CRPC vs PBO (median, not reached vs 12.6 months; HR, 0.09; 95% CI 0.02–0.30). The safety profile of DARO in B/AAs was consistent with that observed for all patients (grade 3/4 adverse events [AEs]: 57.7% vs 66.1%; serious AEs: 42.3% vs 44.8%). The occurrence of discontinuations of DARO/PBO due to AEs and AEs associated with androgen receptor pathway inhibitors (eg, fatigue/asthenia, vasodilation/flushing, hypertension, diabetes/hyperglycemia, cardiac disorders, fall, depressed mood disorders, rash, fracture, decreased weight, mental impairment, and breast disorders/gynecomastia) were similar between treatment groups in B/AAs and consistent with the overall population. Conclusions: In this small population of B/AAs with mHSPC from the ARASENS trial, DARO was associated with an improvement in OS and time to CRPC and was well tolerated. Efficacy and safety findings in B/AAs were consistent with the overall ARASENS population. Citation Format: Neal D. Shore, Maha H.A. Hussain, Fred Saad, Karim Fizazi, Cora N. Sternberg, E. David Crawford, Bertrand Tombal, Luke Nordquist, Michael Cookson, Jay Jhaveri, Silke Thiele, Shankar Srinivasan, Jorge Ortiz, Matthew R. Smith. Efficacy and safety of darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel in Black/African-American patients from the phase 3 ARASENS trial [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B131.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,005 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».