CIRG/TORI 010: 10-Month Analysis of a Randomized Phase II Trial of Motesanib Plus Weekly Paclitaxel as First Line Therapy in HER2-Negative Metastatic Breast Cancer (MBC).
Notice bibliographique
Résumé
Abstract Background: We assessed, in a double-blinded placebo-controlled trial, the effect of adding motesanib (M), a small molecule antagonist of VEGF, PDGF and Kit receptors, to paclitaxel (P) as first line treatment of subjects with MBC. A P plus bevacizumab (B) open-label arm was included. The study was supported by Amgen Inc.Methods: 282 subjects with HER2-negative and measurable MBC were randomly assigned treatment with P 90mg/m2 on days 1, 8 and 15 in combination with blinded placebo (Arm A), blinded M 125mg once daily (Arm B) or open-label B 10mg/kg on days 1 and 15 (Arm C). Treatment was administered in 28-day cycles until disease progression, toxicity or consent withdrawal. The primary objective was to compare objective response rate (ORR: CR or PR) between Arm A and B. Treatment efficacy was assessed every 8 weeks according to RECIST version 1.0 and scans were centrally reviewed.Results: 277 subjects received study treatment. Subject characteristics at entry were balanced: median age was 55, 80% had hormone receptor positive tumors and 66% had received adjuvant chemotherapy. At this analysis, 10 months after last enrolled subject, 235 subjects had completed treatment (median duration: 6 cycles). The median cumulative dose of P was similar across the arms: 1530, 1455 and 1652 mg/m2 in Arms A, B and C, respectively. Subjects received a median cumulative dose of 179 mg/kg of B (Arm C) and a median daily dose of 111 mg of M (Arm B). The table displays the efficacy results and relevant differences in toxicity incidences:More adverse events were reported in Arm B compared to the other arms, mainly grade 3 and 4 gastrointestinal toxicities, hepatobiliary toxicities and hypertension. Infections and stomatitis were more frequently reported in Arm C. Venous thrombo-embolic events were similar across all three arms. Among serious hepatobiliary disorders, 5 subjects experienced serious cholecystitis or gallbladder enlargement: 4 of them were managed by surgery and 4 subjects could resume study treatment.The ORR favored Arms B and C as compared to Arm A, with 49%, 52% and 41% respectively but the difference between Arm A and B was not statistically significant (p=.31, adjusting for stratification factors). Stable disease lasting at least 24 weeks was reported for 34%, 36% and 33% of subject in Arms A, B and C respectively. The Progression-Free Survival (PFS) did not significantly differ between the three arms.Conclusion: The antitumor effect of P and M is comparable to P and B as treatment of subjects with HER2-negative MBC but P and M increases toxicities compared to the other arms. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 47.
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 | 0,003 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,001 |
| Bibliométrie | 0,002 | 0,005 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| 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) | 0,004 | 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 ».