Ribociclib (RIB) + tamoxifen (TAM) or a non-steroidal aromatase inhibitor (NSAI) in premenopausal patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2–) advanced breast cancer (ABC): MONALEESA-7 patient-reported outcomes (PROs)
Notice bibliographique
Résumé
Background: In the Phase III MONALEESA-7 trial (NCT02278120), RIB + TAM/NSAI + goserelin (GOS) significantly improved progression-free survival vs placebo (PBO) + TAM/NSAI + GOS in premenopausal pts with HR+, HER2– ABC; here we report key PRO data. Methods: Pre/perimenopausal pts (N = 672; ≤1 line of prior chemotherapy and no prior endocrine therapy for ABC) were randomized 1:1 to RIB (600 mg/day; 3 weeks on/1 week off) or PBO + TAM (20 mg/day) or an NSAI (letrozole [2.5 mg/day]/anastrozole [1 mg/day]) + GOS (3.6 mg every 28 days). Primary endpoint: PFS. PROs were a secondary endpoint and were evaluated using EORTC QLQ-C30, QLQ-BR23, EQ-5D-5L, and WPAI-GH questionnaires. Changes from baseline and time to 10% deterioration (TTD) in health-related quality of life (HRQoL) were analyzed using linear mixed-effect and stratified Cox regression models, respectively. Results: Questionnaire compliance was high (>75%). On-treatment HRQoL (EORTC QLQ-C30 global health status/QoL score) was maintained up to Cycle (C) 17 in both arms. From C18 onwards, HRQoL improved in the RIB arm (clinically meaningful improvements [>5 points] at C5 and from C19 to C31), but numerically worsened in the PBO arm. Median TTD in HRQoL was not reached (NR) in the RIB arm (95% CI 22.2–NR) vs 21.2 months in the PBO arm (95% CI 15.4–23.0; hazard ratio 0.699; 95% CI 0.533–0.916; p = 0.004). EORTC QLQ-C30 physical, social, and role functioning domains, and WPAI-GH % work time missed were maintained in the RIB arm; physical and role functioning were maintained for a longer duration in the RIB vs PBO arm. WPAI-GH % activity impairment was maintained in the RIB vs PBO arm. Reductions in EORTC QLQ-C30 pain score were observed up to C28 in the RIB arm and up to C17 in the PBO arm; clinically meaningful reductions were observed in the RIB arm from C3 to C11 and C22 to C28. Conclusions: RIB + TAM/NSAI + GOS improves HRQoL and maintains functioning, work productivity, and activity in premenopausal pts with HR+, HER2– ABC. RIB + TAM/NSAI + GOS is also associated with a clinically meaningful reduction in pain vs PBO + TAM/NSAI + GOS. Clinical trial identification: NCT02278120, 29 October 2014. Editorial acknowledgement: Bhavika Modasia PhD of ArticulateScience Ltd. Legal entity responsible for the study: Novartis Pharmaceuticals Corporation. Funding: Novartis Pharmaceuticals Corporation. Disclosure: N. Harbeck: Personal fees for lectures/consulting: Eli-Lilly, Novartis, Pfizer, during the conduct of the study. P. Wheatley-Price: Personal fees for advisory boards: Novartis, AstraZeneca, Lilly Oncology, Bristol-Myers Squibb, Merck, Takeda, during the conduct of the study. B. Lanoue: Employed by Novartis Pharmaceuticals Corporation, during the conduct of the study. J. Alam: Employment: Novartis. D. Chandiwana: Employment and stock ownership: Novartis. M. Colleoni: Fees for advisory boards: AstraZeneca, Pierre Fabre, Pfizer, OBI Pharma, Puma Biotechnology, and Celldex; Honoraria: Novartis, outside the submitted work. All other authors have declared no conflicts of interest.
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 | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,001 |
| 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 ».