Mapping PRO-CTCAE responses to clinician-graded adverse events, dose reductions, interruptions, and discontinuations in phase I cancer trials.
Notice bibliographique
Résumé
2014 Background: Typically symptomatic adverse events (sy-AEs) on clinical trials are reported by clinicians using the CTCAE. To complement clinician collected sy-AEs and understand tolerability better, the patient report outcome version of the CTCAE (PRO-CTCAE) has been developed to provide the patient (pt) perspective on severity of AEs (graded scale 0-4) and their interference in daily life (scale 0-4). The aim of this study was to correlate PRO responses with the grade (G) of AEs, dose interruptions/reductions and dose limiting toxicities (DLTs). Methods: Pts enrolled on phase 1 clinical trials at Princess Margaret were surveyed electronically on tablet using the full library of items for PRO-CTCAE. The PRO-CTCAE was administered at baseline (prior to therapy), mid-cycle 1, and mid-cycle 2. AEs on study were recorded by physicians using the CTCAE. The electronic medical records were analyzed for an association between reported sy-AEs and PRO score. Summary statistics were used to describe patient and disease characteristics, as well as the outcomes. Spearman’s method was used to correlate PRO severity and interference responses. Logistic regression was used to assess which factors were associated with CTCAE G 3-4 vs G 2 AEs. Results: We analyzed 158 pts: median age 60yrs, 77 (49%) were male; all were ECOG ≤1 and 22, 55 and 81 pts completed 1, 2 and 3 surveys, respectively. Clinician reported G2, 3 and 4 sy-AEs occurred in 81, 47 and 3 pts, respectively and all of these were related to a PRO item except 5% (4/81), 9% (4/47) and 33% (1/3), respectively because either the AE occurred after 3 rd time point or patient not able to complete the PRO (encephalitis). Sy-AEs causing dose interruptions, reductions, DLTs and discontinuations occurred in 45 (28%), 12 (7.5%), 5 (3%) and 12 (7.5%) pts, respectively; with a corresponding PRO item in 40 (89%), 12 (100%), 4 (80%) and 11(92%) pts, respectively. For patients who had CTCAE G2, G3/4 AEs, interruptions and discontinuations, their severity and inference levels were positively correlated (coefficient 0.49, p < 0.001; 0.45, p < 0.001 0.59, p < 0.001, 0.86, p < 0.001). Dose interruptions (p = 0.0027) and reductions (p = 0.0061) were significantly associated with G3-4 compared to G2 AEs. Conclusions: This is the first time an association between PRO-CTCAE severity and interference; and CTCAE G2, 3, 4 AEs, dose interruptions and discontinuations has been demonstrated. Additional modelling and more patient data are being analyzed to explore the relationship.
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 | 0,042 | 0,722 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,004 | 0,001 |
| 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 | 0,001 | 0,002 |
| 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; les deux têtes enseignantes s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».