Abstract C69: Preliminary activity of temsirolimus, an mTOR inhibitor, in patients with recurrent, unresectable, locally advanced or metastatic carcinoma of the cervix: An NCIC-CTG phase II clinical trial.
Notice bibliographique
Résumé
Abstract Background: The PI3K-Akt-mTOR pathway is deregulated in invasive cervical carcinomas, possibly as a result of HPV infection. This NCIC CTG 2-stage phase II study aimed to assess the activity of intravenous (IV) temsirolimus, an ester derivative of rapamycin that inhibits mTOR, in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. Methods: Eligibility criteria included: squamous, adenosquamous or adenocarcinoma histology, measurable disease, and PFS ≤2. Prior concurrent chemoradiation and 1 prior line of chemotherapy were permitted. Primary endpoint was objective response (by RECIST 1.1), secondary endpoints included response duration, time to progression and molecular correlates of outcome in archival tissue. Temsirolimus 25 mg i.v. was administered weekly in 4 week cycles. Tumor response was assessed every 8 weeks. One response amongst the first 18 patients was required to proceed to the second stage of accrual. Results: 35 pts (data on 31 available) have been enrolled to date, 28 are now evaluable for toxicity and 23 for response. Follow up is ongoing. 20 pts had received prior chemoradiation and 15 prior chemotherapy for metastatic disease. 19 pts had squamous, 8 adeno and 4 adenosquamous histology. Median age was 52 (range 26–77) yrs. A total of 110 cycles of treatment (median 3; range 1–12) were delivered. 33% of patients received >/= 90% of the planned dose intensity. To date 1 had a partial response (4.3%) lasting 7.2 months, and 15 stable disease (65.2%) median duration of 6.9 months (range 2.4–12.0 months), 11 pts remain on treatment. The median progression free survival was 5.49 months [95% CI (3.65–7.62)]. The most common drug related adverse events of any grade (% of pts) were: fatigue (39%), mucositis (36%), rash maculo-papular (32%), diarrhea (29%), rash-acneiform (21%), and anorexia (18%). Grade 3 hematologic and biochemical toxicites included: lymphopenia (41%), anemia (15%), hyponatremia (11%), hypertriglyceridemia (11%), hyperglycemia (11%), and hypokalemia (7%). No toxicity > grade 3 was observed. Two patients came off study because of adverse events (thromboembolic event and pneumonitis). Six patients experienced 7 serious and possibly drug related adverse events [rash (1), anemia (2), abdominal pain (1), thromboembolism (1), parasthesia (1), edema (1), and diarrhea (1)]. Seven pts required dose reductions, most commonly for the occurrence of rash or mucositis. Conclusions: Single agent temsirolimus has modest levels of activity in cervical carcinoma with a notably high proportion and duration of disease stabilization. Correlative studies of PI3K pathway will examine which tumor characteristics are associated with PR + SD and this will assist in focusing future investigation of temsirolimus. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2011 Nov 12-16; San Francisco, CA. Philadelphia (PA): AACR; Mol Cancer Ther 2011;10(11 Suppl):Abstract nr C69.
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) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| 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 | 0,000 |
| 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 ».