Abstract P5-13-20: Overall survival of women with breast cancer treated with newly approved targeted drugs in Manitoba: A population based study
Notice bibliographique
Résumé
Abstract Background: Cancer drugs are approved based on the results of clinical trials in selected, rigorously monitored groups of participants. The ultimate goal of new cancer drug approvals is to improve outcomes, preferably overall survival, at population level compared to existing standard of care. Methods: We conducted a population based study using data from the provincial Manitoba cancer registry, Manitoba Health, and electronic patient records. We collected data on patient demographics, toxicity outcomes, and efficacy outcomes including recurrence and Overall Survival (OS) of patients who were treated with the 10 most frequently used new targeted cancer drugs between January 2005 and December 2017 in Manitoba. Patient demographics were reported using descriptive statistics. Toxicity events were reported in frequency, and Kaplan-Meier curves were used for time-to-event outcomes. Results: Four breast cancer drugs – Trastuzumab Emtansine (T-DM1), pertuzumab, fulvestrant, and palbociclib qualified for inclusion. During the timeframe, 71 women were treated with T-DM1, 100 with pertuzumab, 102 with Fulvestrant, and 21 with palbociclib. Patient demographics, disease stage, and line of therapy were comparable to those reported in pivotal trials leading to approval of these drugs. Median OS was 15.82 months for T-DM1, 25.34 months for pertuzumab, 14.65 months for fulvestrant, and not assessable for palbociclib – of note, these were consistently about half the median OS duration reported in pivotal trials leading to approval of the respective drugs. [For example, median OS in pivotal trials was 55.6 months for pertuzumab, 29.9 months for T-DM1, up to 26.4 months for fulvestrant, and 37.5 months (one trial) for palbociclib]. Serious toxicities were observed more frequently than reported in the literature – detailed results will be presented. Conclusion: Despite impressive improvements in outcomes reported in clinical trials leading to approval of new targeted therapies for breast cancer, such agents only yield modest OS at population level which was often worse than even the control groups used in pivotal clinical trials. Given the main aim of new interventions are to improve outcomes at population level, future research should explore causes, and identify solutions to minimize such efficacy-effectiveness gaps. Cautious patient selection, early identification and management of toxicities, and increasing resources available to individual patients may minimize such gaps. Citation Format: Devgan S, Bucher O, Geirnaert M, Niraula S. Overall survival of women with breast cancer treated with newly approved targeted drugs in Manitoba: A population based study [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-13-20.
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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 | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| 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 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 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 ».