8-year outcomes of enzalutamide (ENZA) versus a non-steroidal anti-androgen (NSAA) for metastatic, hormone-sensitive prostate cancer (ENZAMET; ANZUP 1304).
Notice bibliographique
Résumé
5090 Background: We previously reported that ENZA improved overall survival (OS) after median follow-up times of 34 and 68 months, in comparison with a NSAA, when added to testosterone suppression, with or without concurrent early docetaxel, for mHSPC. We now report outcomes after median follow-up of 98 months. Methods: Participants (pts) with mHSPC were randomly assigned (1:1) from 31MAR2014-24MAR2017 to treatment with ENZA 160 mg or NSAA, in addition to testosterone suppression. Concurrent early docetaxel was used in 45%. OS was the primary endpoint and analysed with the Kaplan-Meier method, log-rank test for p-values, and Cox regression for hazard ratios (HR). Secondary outcomes included deaths due to prostate cancer (PC) versus (vs) other causes. The numbers of pts experiencing specified adverse events (AE) of grade 3-5 are expressed per 100 person-years of study treatment exposure to account for differing treatment durations. Results: After a median follow-up of 98 months, data cut-off 30JUN2024, death was reported in 285/563 (51%) pts assigned ENZA vs 337/562 (60%) assigned NSAA. OS was longer among those assigned ENZA than NSAA (medians 95 vs 70 months; OS at 96 months 50% vs 40%; HR 0.73, 95% CI 0.63 to 0.86; p=0.0001). Clinical PFS also continued to favour ENZA over NSAA (HR 0.49; 95% CI 0.42 to 0.57; p<0.0001). PC accounted for 468 of all 622 deaths, and were less frequent among those assigned ENZA than NSAA (207 vs 261). Deaths due to other causes accounted for a total of 154 deaths, and were similarly frequent among those assigned ENZA vs NSAA (78 vs 76). Mean duration of study treatment was longer for ENZA than NSAA (58 vs 36 months). 185/562 (33%) remain on ENZA with 88% on full dose. G3-5 AE of interest were reported in the following numbers of pts per 100 years of study treatment with ENZA vs NSAA: cardiac disorder 2.2 vs 2.2, nervous system disorder 2.3 vs 2.0, fall 0.70 vs 0.24. Causes of death according to PSA at 7 months are tabulated below. Among those with PSA at 7 months ≤0.2, deaths were due to PC in 29%, and other causes in 13%. Among those with PSA at 7 months >0.2, deaths were due to PC in 60%, and other causes in 13%. Conclusions: Treatment with enzalutamide continues to confer substantial OS benefits at 8 years. These findings highlight long-term safety, toxicities, non-PC causes of death, and survival outcomes of those with and without PSA ≤0.2 at 7 months. ClinicalTrials.gov Identifier NCT02446405. Clinical trial information: NCT02446405 . Landmark analysis by PSA at 7 months ENZA (N=555) NSAA (N=549) ALL (N=1104) Deaths due to prostate cancer, PSA ≤0.2 100/375 (27%) 87/270 (32%) 187/645 (29%) Deaths due to other causes, PSA ≤0.2 54/375 (14%) 33/270 (12%) 87/645 (13%) Deaths due to prostate cancer, PSA >0.2 104/180 (58%) 170/279 (61%) 274/459 (60%) Deaths due to other causes, PSA >0.2 22/180 (12%) 39/279 (14%) 61/459 (13%)
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) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| 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 ».