P5-19-08: Pooled Analysis of Individual Patient Data from Capecitabine Monotherapy Clinical Trials in Anthracycline-/Taxane-Pretreated Locally Advanced or Metastatic Breast Cancer (LA/MBC).
Notice bibliographique
Résumé
Abstract Background Capecitabine (C) has shown efficacy as monotherapy in anthracycline (A)-/taxane (T)-pretreated LA/MBC in phase II/III trials. Since its approval, the treatment landscape in MBC has evolved, and C has served as the combination partner and/or active comparator in trials of novel agents in pretreated MBC. This pooled analysis of clinical trial data, spanning a 12-yr period, assessed the efficacy and safety of C across treatment lines and the impact of disease characteristics on clinical outcomes with C. Methods: Individual patient (pt) data were pooled from 7 clinical trials conducted by Roche/GNE from Feb 1996-Jun 2008 where C monotherapy was the test/control regimen for pts with LA/MBC with/without prior A/T therapy. Analyses were performed on an ITT basis. Univariate and multivariate regression analyses assessed the impact of pt/disease characteristics and prior therapy on outcomes. Results: Data from 805 pts enrolled to intermittent C monotherapy were analyzed: 268 in the 1st-line metastatic setting; 537 in the ≥2nd-line metastatic setting (table). Median age: 55 yrs (range 23–90). Most pts were Caucasian (81%) with ECOG PS of 0 (55%). Baseline demographics were balanced across treatment lines. Data on A/T treatment history were available for 719 pts; 557 pts received prior A/T therapy, 176 were A-refractory, 234 T-refractory and 154 A- and T-refractory. Pooled overall response rate (ORR) was 21.0% (1.7% complete; 19.3% partial). ORR was 25.0% and 19.0% for pts treated in the 1st- and ≥2nd-line settings (OR 0.70, 95% CI: 0.5−1.0; p=0.0486). Median PFS was 126.9 days (95% CI: 119–132) in the pooled analysis, and significantly longer in pts receiving 1st- vs ≥2nd-line C: 150.0 vs 112.0 days (HR 1.45, 95% CI: 1.23−1.71; p<0.0001). Pooled median OS was 482.1 days (95% CI: 438–516). Significantly longer median OS was seen in pts receiving 1st- vs ≥2nd-line C: 666.0 vs 396.0 days (HR 1.98, 95% CI: 1.62−2.41; p<0.0001). 62 pts (8%) withdrew due to C-related AEs, which were severe in 4% of pts and life threatening in 2%. AEs of special interest occurred in 489 pts (63%); these were severe in 24% of pts and life threatening in 2%. Gastrointestinal disorders were most frequent (417 pts [53%]), and were severe or life threatening in 13% and 1% of pts. Conclusions: This pooled analysis of pt data (n=805) revealed significantly longer ORR/survival in pts receiving 1st- vs ≥2nd-line C for A-/T-pretreated MBC. Univariate and multivariate analyses are ongoing; results will be presented. Safety data were in-line with findings from phase III trials of C in MBC. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-19-08.
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 | 0,027 | 0,026 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,004 | 0,008 |
| Bibliométrie | 0,003 | 0,004 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| 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 ».