HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH TRANSPLANT-INELIGIBLE OR TRANSPLANT-DEFERRED NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) IN THE PHASE 3 CEPHEUS TRIAL
Notice bibliographique
Résumé
Previous daratumumab clinical trials showed no detriment to health-related quality of life (HRQoL) with addition of daratumumab as part of a triplet or quadruplet treatment regimen. In the phase 3 CEPHEUS trial (NCT03652064), minimal residual disease negativity and progression-free survival improved with subcutaneous daratumumab plus bortezomib and Rd (DVRd) vs VRd in pts with newly diagnosed multiple myeloma (NDMM). Evaluate HRQoL of DVRd vs VRd in CEPHEUS. Pts had transplant-ineligible (TIE) or transplant-deferred (TD) NDMM, ECOG performance status ≤2, and International Myeloma Working Group frailty score ≤1. Pts were randomized 1:1 to DVRd or VRd. Patient-reported outcomes (PROs) were evaluated at baseline (BL), once each cycle to C8D1, and every 3rd C from C9D1 until disease progression. PROs included the European Organization for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC QLQ-C30), EORTC QLQ multiple myeloma 20 (EORTC QLQ-MY20), and the EuroQol 5-Dimension 5-Level (EQ-5D-5L). The intent-to-treat population had 395 pts (DVRd, n = 197; VRd, n = 198). Median follow-up was 58.7 months; 135 pts in the DVRd arm and 106 in the VRd arm were on study treatment at C36. Compliance was >85% at BL and >81% through C36 in both arms. For all questionnaires, BL means were comparable, and similar improvements in least square (LS) mean change from BL were seen across arms. At C36, the LS mean change from BL (95% CI) in EORTC QLQ-C30 global health status was 8.2 for DVRd and 8.5 for VRd with no apparent difference between arms. For EORTC QLQ-C30, the LS mean change from BL at C36 was 3.6 for DVRd and 5.1 for VRd (difference −1.5 [−6.4, 3.4], P = 0.54). For fatigue, these changes were −4.7 (−8.6, −0.7) for DVRd and −5.4 (−9.6, −1.2) for VRd (difference 0.7 [−4.9, 6.3], P = 0.80). For pain, reduction from BL was numerically higher with DVRd (−14.8) vs VRd (−8.7; difference −6.1 [−12.7, 0.5], P = 0.06). LS mean change from BL in EORTC QLQ-MY20 disease symptoms score at C36 was −8.4 for DVRd and −9 for VRd (difference 0.6 [−3.5, 4.7], P = 0.78). For EQ-5D-5L visual analogue scale (VAS) score, these changes were 7.3 () in DVRd and 5.6 () in VRd (difference 1.7 [−2.4, 5.7], P = 0.41). For all scales, a similar median time to worsening and time to improvement were observed across arms. PROs of the TIE subgroup had similar results. DVRd-treated pts in CEPHEUS had improved HRQoL and physical functioning as well as symptom (pain, fatigue, overall disease symptoms) reduction from BL. Improvements were similar vs VRd with no apparent differences between arms, indicating no detriment to HRQoL with addition of daratumumab. This study was funded by Johnson & Johnson. Medical writing support was provided by Shuang Li, PhD, of Eloquent Scientific Solutions, and funded by Johnson & Johnson.
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) | 0,000 | 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 | 0,000 | 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) | 0,001 | 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 ».