The Advanced Renal Cell Carcinoma Sorafenib (ARCCS) expanded access trial: Subset analysis of patients (pts) with brain metastases (BM)
Notice bibliographique
Résumé
15506 Background: Sorafenib (SOR) was demonstrated to be safe and effective in a phase III trial of previously treated RCC pts; however, pts with BM were excluded. BM occur in 5–10% of RCC pts, and generally portend a poor prognosis. Safety and efficacy of SOR in this pt population was therefore explored in a subset analysis of ARCCS, a community-based expanded access program. Methods: Pts received SOR 400 mg bid in this open-label, nonrandomized trial if they were =15 years old with advanced RCC and had ECOG PS of 0–2. Pts with BM were included but required to have some prior local therapy for their brain lesions. Prior treatment did not have to be successful, and pts whose BM had been surgically removed were also eligible for this protocol. BM were excluded as target lesions for RECIST unless they were the only lesions being followed. Major exclusion criteria included treatment with other investigational drugs within 4 wks of enrollment; life expectancy <2 mos; active coronary artery disease, ischemia, or hypertension; and severe renal impairment requiring dialysis. The primary endpoints were safety and efficacy (per investigator assessed RECIST criteria). Results: Of 2,488 ARCCS pts valid for safety, 65 (2.6%) had been previously treated for BM: 72.3% male with median age 59.5 yrs. 99% had =1 prior therapy for non-brain disease including 81.5 % radiotherapy, 78.5% nephrectomy and 47.7% prior systemic therapy. Grade 3 adverse events (AE) occurring >2% in this subset were fatigue and seizure (6.2% each) and hand-foot skin reaction, diarrhea, hemoglobin, mucositis, dehydration, vomiting, hyperglycemia, and thrombosis (3.1% each). In the total ARCCS population vs the BM subset, Grade 3 AEs were 35.2% vs 26.2% and Grade 4 AEs were 6.1% vs 9%. There were no CNS-related bleeding events in pts with BM. Of the 47 pts evaluable for response, partial response was reported in 2 (4%), stable disease in 33 (70%), and progressive disease in 12 (26%). Conclusions: The toxicity and efficacy of SOR in pts with brain mets in ARCCS were comparable to those observed in the whole study population. Of note, SOR was well tolerated in this study with no reports of cerebral hemorrhagic events. [Table: see text]
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) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 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 ».