LUMINA: A prospective trial omitting radiotherapy (RT) following breast conserving surgery (BCS) in T<sub>1</sub>N<sub>0</sub> luminal A breast cancer (BC).
Notice bibliographique
Résumé
LBA501 Background: Adjuvant breast RT is usually prescribed following BCS to reduce the risk of local recurrence (LR). However, this treatment is inconvenient, costly, and associated with acute and late toxicity. Traditional clinical pathological factors (CPFs) alone are limited in their ability to identify women with a low enough risk of LR to omit RT. Molecular defined intrinsic subtypes of BC provide additional prognostic information with luminal A having the lowest risk of recurrence. A retrospective analysis of a previous trial suggested that women >60 years with luminal A grade 1-2 T 1 N 0 BC treated by BCS and endocrine therapy alone had a low rate of LR ( JCO 2015; 33:2035). The utility of identifying luminal A subtype combined with CPFs has not been prospectively evaluated for its ability to guide RT decision-making. Methods: A prospective multicenter cohort study was performed. Eligibility criteria were: women ≥ 55 years; having undergone BCS for grade 1-2 T 1 N 0 BC; ≥ 1mm margins of excision; luminal A subtype (defined as: ER ≥ 1%, PR>20%, HER2 negative and Ki67 ≤ 13.25%); and treated with adjuvant endocrine therapy. ER, PR and HER2 were performed locally as per ASCO guidelines. Patients meeting clinical eligibility with ER ≥ 1%, PR>20%, HER2 negative BC were registered and had Ki67 immunohistochemistry performed centrally in one of three Canadian laboratories using International Ki67 Working Group methods. Proficiency testing between laboratories was performed yearly. Patients with Ki67 ≤ 13.25% were enrolled in the trial and were assigned to not receive RT. The primary outcome was LR defined as time from enrollment to any invasive or non-invasive cancer in the ipsilateral breast. Assuming a 5-year LR rate of 3.5%, 500 patients were required to show that the upper bound of a two sided 90% (one-sided 95%) confidence interval (CI) was <5%. Patients were followed every six months for the first two years and then yearly. The probability of LR was estimated using the cumulative incidence function with death as a competing risk. Secondary outcomes were contralateral BC; relapse free survival (RFS) based on any recurrence; disease free survival (DFS) based on any recurrence, second cancer or death; and overall survival (OS). Results: From August 2013 to July 2017, 501 of 727 registered patients from 26 centers had a Ki67 ≤ 13.25% and were enrolled. Median follow-up was 5 years. Median age was 67 and 442 (88%) patients were <75 years. Median tumor size was 1.1 cm. The 5-year rate of LR satisfied our pre-specified boundary (see Table). Conclusions: Women ≥ 55 years with grade 1-2 T 1 N 0 luminal A BC following BCS treated with endocrine therapy alone had very low rates of LR at 5 years and are candidates for omission of RT. Clinical trial information: NCT01791829. [Table: see text]
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 | 0,005 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,001 |
| 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 | 0,001 |
| 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 ».