PS1026 ENASIDENIB ASSOCIATED WITH IMPROVED SURVIVAL COMPARED WITH STANDARD OF CARE FOR R/R AML PATIENTS WITH AN IDH2 MUTATION BASED ON DATA FROM STUDY AG221‐C‐001 AND A REVIEW OF PATIENT CHARTS IN FRANCE
Notice bibliographique
Résumé
Background: Enasidenib is approved for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase‐2 (IDH2) mutation. Supporting data for the use of enasidenib in patients with R/R AML and an IDH2 mutation are available from the phase 1/2 AG221‐C‐001 single‐arm study (NCT0915498); direct comparative efficacy data for enasidenib are not available. Aims: To compare the overall survival (OS) associated with enasidenib 100 mg daily and standard of care (SoC) in patients with R/R AML and an IDH2 mutation not eligible for hematopoietic stem cell transplantation (HSCT). Methods: Propensity score matching (PSM) analysis was conducted using individual patient data (IPD) for patients treated with 100 mg of enasidenib daily from the phase 1/2 AG221‐C‐001 study, and IPD for real‐world patients treated with SoC from a review of patient charts at 9 French sites. Covariates selected for calculating propensity scores (PS) included history of HSCT before baseline, age, number of prior lines of AML therapy at baseline, cytogenetic risk at baseline, and history of myelodysplastic syndromes. For the primary analysis, PSM was performed using optimal 1:1 matching and excluded patients undergoing HSCT after baseline. Hazard ratios (HRs) were estimated from Cox proportional hazards models that adjusted for PS covariates in matched populations. Robustness of results was assessed by a range of sensitivity analyses including different matching algorithms and other prognostic factors. Results: Prior to performing PSM, considerable differences between patients treated with enasidenib (N = 195) and patients treated with SoC (N = 80) were observed with respect to number of prior lines of therapy, prior HSCT, and cytogenetic risk profile, as determined by higher standard mean differences (SMDs) in the pre‐matched population compared with the post‐matched population. Before PSM, patients treated with enasidenib had improved OS compared with SoC (HR 0.82; 95% confidence internal [CI] 0.61–1.11). After matching (enasidenib n = 78; SoC n = 78) and adjusting for covariates, mortality risk was significantly lower for enasidenib compared with SoC and the 95% CI excluded the value 1 (HR 0.67, 95% CI 0.47–0.97). The median survival time for enasidenib was 9.3 months (95% CI 7.7–13.2) compared with 4.8 months (95% CI 3.8–8.2) for SoC (Figure). All sensitivity analyses had mortality HR point estimates that were in favor of enasidenib and excluded 1 from their respective 95% CI in most cases. The results from the sensitivity analyses were consistent with the primary analysis. Summary/Conclusion: Patients with R/R IDH2‐mutated AML not eligible for HSCT who were treated with enasidenib on study had improved survival compared with patients receiving SoC in a real‐world setting. Future studies are needed to validate these findings using other data sources, to compare enasidenib with specific treatments and to assess the comparative efficacy of enasidenib for other outcomes. image
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 | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,004 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| 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) | 0,000 | 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 ».