MP34-17 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER: POST HOC ANALYSIS OF PROSPER BY PROSTATE SPECIFIC-ANTIGEN PROGRESSION
Notice bibliographique
Résumé
You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) IV (MP34)1 Apr 2019MP34-17 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER: POST HOC ANALYSIS OF PROSPER BY PROSTATE SPECIFIC-ANTIGEN PROGRESSION Fred Saad*, Cora N. Sternberg, Eleni Efstathiou, Karim Fizazi, Katharina Modelska, Xiaowei Guan, Jennifer Sugg, Joyce Steinberg, and Bettina Noerby Fred Saad*Fred Saad* More articles by this author , Cora N. SternbergCora N. Sternberg More articles by this author , Eleni EfstathiouEleni Efstathiou More articles by this author , Karim FizaziKarim Fizazi More articles by this author , Katharina ModelskaKatharina Modelska More articles by this author , Xiaowei GuanXiaowei Guan More articles by this author , Jennifer SuggJennifer Sugg More articles by this author , Joyce SteinbergJoyce Steinberg More articles by this author , and Bettina NoerbyBettina Noerby More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555909.47437.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Nonrising prostate-specific antigen (PSA) at radiographic progression may occur in patients with metastatic castration-resistant prostate cancer (CRPC) treated with enzalutamide. In the primary analysis of PROSPER, enzalutamide provided a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) in patients with nonmetastatic (nm) CRPC. Here we report results in patients with or without PSA progression, defined according to PCWG2, at the time of metastasis or death. METHODS: Eligible patients with nmCRPC on bone and computed tomography scan, PSA doubling time ≤ 10 months, and PSA ≥ 2 ng/mL at screening continued androgen deprivation therapy and were randomized 2:1 to enzalutamide 160 mg or placebo. The primary endpoint was MFS. RESULTS: 1,401 patients were enrolled, with a median age of 74 years (range, 50-95 years). In all patients, enzalutamide reduced the risk of metastasis or death by 71% (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.24-0.35; P < .0001). Overall, 869 patients (62%) did not have PSA progression at the data cutoff date of June 28, 2017 (n/N = 725/933 [78%] in the enzalutamide group; n/N = 144/468 [31%] in the placebo group). Enzalutamide significantly reduced the risk of metastasis or death regardless of whether patients had PSA progression (HR with PSA progression, 0.57; 95% CI, 0.45-0.73; HR without PSA progression, 0.19; 95% CI, 0.13-0.29) (Table). CONCLUSIONS: In patients with nmCRPC and rapidly rising PSA, enzalutamide treatment resulted in a clinically meaningful and statistically significant reduction in the risk of developing metastases or death regardless of whether patients had PSA progression. The treatment effect was even greater in patients who did not have PSA progression. This finding requires further evaluation. Clinical trial identification: NCT02003924 Source of Funding: Pfizer Inc. and Astellas Pharma, Inc. Montreal, Canada; New York, NY; Houston, TX; Villejuif, France; San Francisco, CA; Northbrook, IL; Vejle, Denmark© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e502-e502 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Fred Saad* More articles by this author Cora N. Sternberg More articles by this author Eleni Efstathiou More articles by this author Karim Fizazi More articles by this author Katharina Modelska More articles by this author Xiaowei Guan More articles by this author Jennifer Sugg More articles by this author Joyce Steinberg More articles by this author Bettina Noerby More articles by this author Expand All Advertisement PDF downloadLoading ...
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 | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,003 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,010 | 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 ».