Abstract P3-13-04: Effect of age on tolerability and efficacy of eribulin and capecitabine in patients with metastatic breast cancer treated in study 301
Notice bibliographique
Résumé
Abstract Background: The Phase III trial (NCT00337103) compared eribulin (E) with capecitabine (C) in patients (pts) with metastatic breast cancer (MBC) in the 1st-, 2nd-, and 3rd-line setting. Median overall survival (OS) was 15.9 and 14.5 months (HR 0.88; 95% CI 0.77, 1.00; P = 0.056) and median progression-free survival (PFS) was 4.1 and 4.2 months (HR 1.08; 95% CI 0.93, 1.25; P = 0.30) for E and C, respectively. This analysis compares toxicity and efficacy of E and C in relation to age. Material and methods: In this post-hoc exploratory analysis, the effect of age on the incidence of adverse events (AEs), OS, PFS, and objective response rate (ORR) with E and C were analyzed for two age groups: ≤65 years (E, n = 468; C, n = 491) and >65 years (E, n = 86; C, n = 57). For OS and PFS, analyses were stratified by HER2 and geographic region. Results: With increasing age, the proportion of pts with worse performance status (PS ≥1: 54.5% vs 69.2% for ≤65 and >65 years, respectively), ER+ (47.4% vs 57.3%), and PgR+ MBC (41.3% vs 45.5%) increased, and the proportion with triple-negative MBC decreased (26.6% vs 20.3%). With both treatments, AEs were reported in a higher proportion of pts in the older age group, this becoming more apparent for grade 3+ AEs (E: 64.6% vs 70.2%, and C: 45.0% vs 54.4% for ≤65 and >65 respectively). With E, there was a trend for increased incidence of grade 3/4 neutropenia (45.0% vs 50.0%) and leukopenia (13.7% vs 22.6%) but, in contrast, decreased peripheral sensory neuropathy (3.9% vs 1.2%) with increasing age. For C, there was a trend for increased palmar-plantar erythrodysethesia syndrome (total: 44.4% vs 50.9%; grade 3/4: 14.1% vs 17.5%), and grade 3/4 fatigue (1.8% vs 7.0%) and diarrhea (4.7% vs 10.5%) with increasing age; emesis and nausea were similar for both age groups. Dose adjustments due to AEs with E were slightly higher in the older age group: withdrawals 7.4% vs 10.7%; dose reductions 31.1% vs 36.9%; and dose delays 30.9% vs 36.9%. With C, there was a trend for an increased incidence of withdrawals (9.2% vs 21.1%) and dose delays (34.2% vs 49.1%) due to AEs with increasing age: the incidence of dose reductions was slightly higher in the older age group (31.3% vs 36.8%). In an unadjusted analysis, a trend for improved OS with E vs C was observed in both subgroups (≤65 years: median 15.8 vs 14.5 months; HR 0.90; 95% CI 0.78, 1.04; P = 0.16, and >65 years: median 18.4 vs 14.1 months; HR 0.74; 95% CI 0.50, 1.12; P = 0.16). PFS and ORR for E and C were: median PFS: E, 4.0 and 5.4 months; C, 4.2 and 5.9 months; ORR: E, 10.9% and 11.6%; C, 11.6% and 10.5%, in the ≤65 and >65 groups respectively. Conclusions: This exploratory and unadjusted analysis suggests a trend for improved OS with E in both younger and older pts with MBC. With both treatments there was a suggestion that AEs were reported in a higher proportion of pts in the older age group, this becoming more apparent for grade 3+ events. Specifically, these data suggest an increased incidence of grade 3/4 diarrhea, dose delays, and study withdrawal due to AEs in pts treated with C, and potentially suggest that with E there may be less difference between the AE profile in younger vs older pts than with C. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-13-04.
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 | 0,003 | 0,002 |
| 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 | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 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 ».