Initial report of RTOG 9601, a phase III trial in prostate cancer: Effect of anti-androgen therapy (AAT) with bicalutamide during and after radiation therapy (RT) on freedom from progression and incidence of metastatic disease in patients following radical prostatectomy (RP) with pT2-3,N0 disease and elevated PSA levels.
Notice bibliographique
Résumé
1 Background: To test if long term AAT when combined with RT in these patients (pts) with prostate cancer (PC) will improve cancer control outcomes as well as overall survival (OS). Methods: Post-RP pts with pT3,N0 or with pT2,N0 (and positive margins) who have an elevated PSA were entered on a phase III, double-blinded, placebo-controlled trial of RT alone (64.8 Gy in 1.8 Gy fractions) vs RT + AAT (24 months of bicalutamide, 150mg daily) during and after RT. The primary end point is OS. Results: From 3/98 to 3/03, 771 eligible pts (median age 65) were randomized to RT + AAT (387) or RT alone (383). Pretreatment characteristics were balanced. 672 (87%) had a PSA nadir after RP of < 0.5 ng/mL. 655 (85%) had an entry PSA value of <1.6, 115 (15%) had an entry PSA of 1.6-3.9. Median follow-up was 7.1 years. Actuarial OS at 7 years was 91% for RT + AAT and 86% for RT alone. Too few primary end-point events have occurred to allow a statistical comparison between groups. Freedom from PSA progression (FFP) at 7 years was 57% for RT + AAT and 40% for RT alone (P < 0.0001); for 226 pts with GS < 7 were 63% and 50% (P<0.02), for 411 GS 7 these were 55% and 39% (P<0.0006), and for 134 GS 8-10 were 56% and 26% (P < 0.0008). The 7-yr cumulative incidence of metastatic PC was less in the RT and AAT arm, 7% vs 13% in the RT arm (p<0.041). Late grade 3-4 toxicities were similar in both arms. By category the combined grade 3-4 toxicities for RT + AAT and RT alone were: bladder 6% vs 5% bowel 2% vs 1%, cardiac 3% vs 2%. Gynecomastia (mostly grades 1-2) differed significantly, 89% vs15%. In the RT + AAT arm grade 3 was the highest liver toxicity, which occurred in 3 pts. Conclusions: The addition of 24 months of bicalutamide 150 mg daily during and after RT significantly improved FFP and reduced the incidence of metastatic PC without adding significantly to RT toxicity. The significance of benefit in OS, as well analysis of risk-stratified subsets, wait longer follow-up. No significant financial relationships to disclose.
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 tête enseignante, 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 ».