Comparison of Electronic Surveillance With Routine Monitoring for Patients With Lymphoma at High Risk of Relapse: Prospective Randomized Controlled Phase 3 Trial (Sentinel Lymphoma)
Notice bibliographique
Résumé
Background: Relapse is a major event in patients with lymphoma. Therefore, early detection may have an impact on quality of life and overall survival. Patient-reported outcome measures have demonstrated clinical benefits for patients with lung cancer; however, evidence is lacking in patients with lymphoma. We evaluated the effect of a web-mediated follow-up application for patients with lymphoma at high risk of relapse. Objective: This study aims to demonstrate that monitoring patients via a web application enables the detection of at least 30% more significant events occurring between 2 systematic follow-up consultations with the specialist using an electronic questionnaire. Methods: We conducted a prospective, randomized phase 3 trial comparing the impact of web-based follow-up (experimental arm) with a standard follow-up (control arm). The trial was based on a 2-step triangular test and was designed to have a power of 90% to detect a 30% improvement in the detection of significant events. A significant event was defined as a relapse, progression, or a serious adverse event. The study covered the follow-up period after completion of first-line treatment or relapse (24 months). Eligible patients were aged 18 years and older and had lymphoma at a high risk of relapse. In the experimental arm, patients received a 16-symptom questionnaire by email every 2 weeks. An email alert was sent to the medical team based on a predefined algorithm. The primary objective was assessed after the inclusion of the 40th patient. The study was continued for the duration of the analysis. Results: A total of 52 patients were included between July 12, 2017, and April 7, 2020, at 11 centers in France, with 27 in the experimental arm and 25 in the control arm. The median follow-up was 21.3 (range 1.3-25.6) months, and 121 events were reported during the study period. Most events occurred in the experimental arm (83/119, 69.7%) compared with 30.2% (36/119) in the control arm. A median number of 3.5 (range 1-8) events per patient occurred in the experimental arm, and 1.8 (range 1-6) occurred in the control arm (P=.01). Progression and infection were the most frequently reported events. Further, 19 patients relapsed during follow-up: 6 in the experimental arm and 13 in the control arm (P<.001), with a median follow-up of 7.7 (range 2.8-20.6) months and 6.7 (range 1.9-16.4) months (P=.94), respectively. Statistical analysis was conducted after including the 40th patient, which showed no superiority of the experimental arm over the control arm. The study was therefore stopped after the 52nd patient was enrolled. Conclusions: The primary objective was not reached; however, patient-reported outcome measures remain essential for detecting adverse events in patients with cancer, and the electronic monitoring method needs to demonstrate its effectiveness and comply with international safety guidelines.
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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 | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,000 |
| 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 | 0,000 |
| 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 ».