Health-related quality of life (HRQoL) after progressive disease (PD) in SPARTAN: A phase III trial of apalutamide (APA) versus placebo (PBO) in men with nonmetastatic castration-resistant prostate cancer (nmCRPC)
Notice bibliographique
Résumé
Background: Compared with PBO, APA prolongs the median metastasis-free survival (MFS) by > 2 y (HR = 0.30; 95% CI, 0.24-0.36), and provids a 55% reduction in the risk of symptomatic progression (Sx PD) (HR = 0.45; 95% CI, 0.32-0.63) in patients (pts) with nmCRPC (SPARTAN study, Smith MR, et al. NEJM 2018), with no decline in HRQoL in either treatment group up to the time of developing distant metastases (Mets). Here, we report pt HRQoL following PD. Methods: 1207 pts (median age, both arms: 74 y) with nmCRPC were randomized 2:1 to APA (240 mg QD) or PBO. ADT was continued in all pts. HRQoL was assessed using the pt-reported outcome (PRO) questionnaire Functional Assessment of Cancer Therapy-Prostate (FACT-P). Following development of Mets, pts in the 2 arms received similar treatments, and PROs were collected at 4, 8, and 12 mo. Sx PD was defined as 1) development of a skeletal-related event; 2) initiation of new systemic anticancer treatment due to pain progression or worsening of disease-related symptoms; or 3) development of clinically significant symptoms due to loco-regional tumor progression requiring surgery or radiation. Descriptive statistics were performed for all FACT-P subscales. Results: Group mean PRO scores after PD were available from 341 pts and from 60 pts after Sx PD (Table). These PRO scores were similar for APA vs PBO up to 12 mo after PD. While APA delayed time to Sx PD, once Sx PD was reached there were similar numeric decreases from baseline across FACT-P subdomains up to 12 mo after Sx PD. Conclusions: Relative to PBO, pts treated with APA had a longer MFS, with no decline in HRQoL through the time of Mets, and similar HRQoL after Mets. Sx PD was delayed with APA vs PBO and was associated with a decline in HRQoL in both groups. Thus, HRQoL decline for pts treated with APA was delayed because of a longer time to Sx PD.Table: 804PPRO group mean scoresAPAPBOBaselineBefore MetsAfter MetsaIncludes pts with and without subsequent approved treatment for metastatic CRPC. SE, standard error.BaselineBefore MetsAfter MetsaIncludes pts with and without subsequent approved treatment for metastatic CRPC. SE, standard error.All pts, n797772157396384184Group mean (SE)FACT-P FACT-G117.2 (0.7) 84.1 (0.4)117.4 (0.7) 83.9 (0.5)112.5 (1.9) 80.7 (1.3)116.6 (1.0) 83.4 (0.7)116.6 (1.0) 83.2 (0.7)114.5 (1.6) 81.8 (1.1)BaselineBefore Sx PDAfter Sx PDaIncludes pts with and without subsequent approved treatment for metastatic CRPC. SE, standard error.BaselineBefore Sx PDAfter Sx PDaIncludes pts with and without subsequent approved treatment for metastatic CRPC. SE, standard error.Sx PD subgroup, n646430636330Group mean (SE)FACT-P FACT-G115.2 (2.5) 84.4 (1.9)117.0 (2.4) 84.2 (1.7)108.6 (3.7) 78.6 (2.9)117.8 (2.0) 85.2 (1.5)114.5 (2.2) 82.6 (1.7)105.6 (4.3) 75.3 (3.4)a Includes pts with and without subsequent approved treatment for metastatic CRPC. SE, standard error. Open table in a new tab Clinical trial identification: NCT01946204. Editorial acknowledgement: This study was funded by Janssen Research & Development. Writing assistance was provided by Ann Tighe, PhD, of PAREXEL, and was funded by Janssen Global Services, LLC. Legal entity responsible for the study: Janssen Research & Development. Funding: Janssen Research & Development. Disclosure: D. Cella: Consultant: AbbVie, Astellas, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Inc, Evidera, GlaxoSmithKline, Helsinn, Ipsen, Janssen Research & Development, Novartis; President: FACIT.org. F. Saad: Grants, Personal fees, Non-financial support: Janssen, Astellas, Sanofi, Bayer. B.A. Hadaschik: Grants: German Cancer Aid, German Research Foundation, Profound Medical; Grants Janssen, Uromed; Personal fees: Janssen, Astellas, Bayer, Uromed; Non-financial support: Janssen, Astellas, Bayer. J.N. Graff: Grants: Janssen, Sanofi, Astellas, Merck Bristol-Myers Squibb; Personal fees: Janssen, Sanofi, Astellas, Bayer, Dendreon. H. Uemura: Personal fees: Janssen, Astellas, Takeda, Sanofi, Bayer, and Astra-Zeneca. S. Oudard: Personal fees: Janssen, Sanofi, Astellas, Bayer, Merck. S. Hudgens: Consulting fees: Janssen. K. McQuarrie, M.K. Yu, A. Lopez-Gitlitz, B. Rooney: Employee: Janssen Research & Development; Stock owner: Johnson & Johnson. M. Morris: Consulting fees: Janssen. M.R. Smith: Grants: Janssen; Personal fees: Janssen, Astellas, Bayer. All other authors have declared no conflicts of interest.
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 | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 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 ».