PD15-07 IMPACT OF BONE-TARGETED THERAPIES IN PATIENTS WITH CHEMOTHERAPY-NAIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER ON ENZALUTAMIDE: A POST HOC ANALYSIS OF PREVAIL
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Résumé
You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I (PD15)1 Apr 2019PD15-07 IMPACT OF BONE-TARGETED THERAPIES IN PATIENTS WITH CHEMOTHERAPY-NAIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER ON ENZALUTAMIDE: A POST HOC ANALYSIS OF PREVAIL Fred Saad*, Neal D. Shore, Karim Fizazi, Joyce Steinberg, Janet Kim, Ping Lin, Katharina Modelska, and Tomasz M. Beer Fred Saad*Fred Saad* More articles by this author , Neal D. ShoreNeal D. Shore More articles by this author , Karim FizaziKarim Fizazi More articles by this author , Joyce SteinbergJoyce Steinberg More articles by this author , Janet KimJanet Kim More articles by this author , Ping LinPing Lin More articles by this author , Katharina ModelskaKatharina Modelska More articles by this author , and Tomasz M. BeerTomasz M. Beer More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555460.30099.9fAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Enzalutamide (ENZA) prolongs radiographic progression-free survival (rPFS) and overall survival (OS) in men with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC). Men with mCRPC are at high risk of developing bone metastases; skeletal complications of bone metastases contribute to morbidity, pain, and death. In this exploratory post hoc analysis of PREVAIL, we analyzed clinical outcomes associated with bone-targeted therapies (BTT) and ENZA vs. ENZA alone. METHODS: The Phase 3 PREVAIL study (NCT01212991) randomized men with mCRPC 1:1 to ENZA (160 mg) or placebo (PBO) with continued androgen-deprivation therapy. Target population for this post hoc analysis was men with bone metastases at baseline, grouped by pre-study baseline BTT use. Co-primary endpoints were rPFS and OS. Eastern Cooperative Oncology Group performance status (ECOG PS) deterioration was defined as time from randomization to first evidence of ECOG PS deterioration by ≥1 grade. Results are presented as hazard ratio (HR) (95% confidence interval [CI]). RESULTS: Of 1429 men, 410 had pre-study BTT use (ENZA, n=534; ENZA + BTT, n=206; PBO, n=485; PBO + BTT, n=204). The risk of rPFS was similar between ENZA + BTT and ENZA alone (HR [95% CI]=1.05 [0.69, 1.60], p=0.4408), whereas the risk of death was higher in ENZA + BTT vs. ENZA alone (1.44 [1.08, 1.92], p=0.0076) (Table). There was a 31% reduction in the risk of rPFS in PBO + BTT vs. PBO alone (0.69 [0.52, 0.93], p=0.0075), and the risk of death was similar between PBO + BTT and PBO alone (0.90 [0.69, 1.19], p=0.2669). The risk of ECOG PS deterioration was similar between ENZA + BTT and ENZA alone (1.06 [0.84, 1.33], p=0.6367), and between PBO + BTT and PBO alone (0.94 [0.74, 1.20], p=0.3615). CONCLUSIONS: In men from PREVAIL with bone metastases at baseline, pre-study BTT use with ENZA was not associated with improved clinical outcomes vs. ENZA alone. rPFS was improved in men taking PBO + BTT vs. PBO alone. The results of these exploratory analyses suggest that BTTs do not improve outcomes in combination with first-line ENZA in mCRPC. Further analysis of optimal timing and combinations when using BTTs remains relevant. Source of Funding: This study was funded by Astellas Pharma Inc. and Medivation LLC, a Pfizer Company, the co-developers of enzalutamide. Medical writing assistance was provided by Patrick Gonyo, PhD, and editorial assistance was provided by Jane Beck from Complete HealthVizion, funded by the study sponsors. Montreal, QC; Myrtle Beach, SC; Villejuif, France; Northbrook, IL; San Francisco, CA; Portland, OR© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e239-e240 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Fred Saad* More articles by this author Neal D. Shore More articles by this author Karim Fizazi More articles by this author Joyce Steinberg More articles by this author Janet Kim More articles by this author Ping Lin More articles by this author Katharina Modelska More articles by this author Tomasz M. Beer 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 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,005 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,000 |
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 ».