Abstract P2-08-02: Progression-free survival results in patient subgroups from a Phase 3 randomized trial of fulvestrant 500 mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON)
Notice bibliographique
Résumé
Abstract BACKGROUND Improved efficacy was suggested for fulvestrant 500 mg, a selective estrogen receptor degrader (SERD), vs anastrozole as first-line treatment for hormone receptor-positive locally advanced or metastatic breast cancer (LA/MBC) in the open-label Phase 2 FIRST trial. The Phase 3, randomized, double-blind, multicenter FALCON trial (NCT01602380) compared fulvestrant 500 mg with anastrozole 1 mg in patients with hormone receptor-positive LA/MBC who had not received prior hormonal therapy. The primary endpoint of the study was met, such that there was a statistically significant improvement in progression-free survival (PFS) for fulvestrant 500 mg vs anastrozole. We present an analysis of PFS for pre-specified patient subgroups in the FALCON trial. METHODS Eligible patients had ER and/or progesterone receptor (PgR)-positive breast cancer, WHO performance status 0–2 and ≥1 measurable/non-measurable lesion(s). Patients were randomized (1:1) to receive fulvestrant 500 mg (IM on Days 0, 14, 28, and each 28 days thereafter) or anastrozole 1 mg daily. The primary endpoint was PFS, assessed via RECIST 1.1, surgery/radiotherapy for disease worsening, or death (any cause). PFS was evaluated in patient subgroups defined by pre-specified baseline covariates. The consistency of effect across patient subgroups was assessed via hazard ratios and 95% confidence intervals using a log-rank test. RESULTS Overall, 462 patients were randomized to treatment: 230 received fulvestrant 500 mg and 232 received anastrozole. PFS outcomes in each patient subgroup are presented in the Table. CONCLUSIONS This analysis of patient subgroups from the FALCON trial suggests that treatment effects were largely consistent across the subgroups analyzed with some possible exceptions (e.g. patients with visceral vs non-visceral disease). Further work is ongoing to understand the possible treatment effect in these subgroups. PFS in pre-specified patient subgroupsSubgroup Number of patients (%) with event Hazard ratio (95% CI) Fulvestrant 500 mg n=230 Anastrozole n=232 Breast cancer type Locally advanced11/28 (39.3%)14/32 (43.8%)0.79 (0.36, 1.73)Metastatic132/202 (65.3%)152/200 (76.0%)0.78 (0.62, 0.99)Prior chemotherapy for LA/MBC Yes31/36 (86.1%)33/43 (76.7%)1.08 (0.66, 1.77)No112/194 (57.7%)133/189 (70.4%)0.75 (0.59, 0.97)Geographic regiona US/Canada16/25 (64.0%)19/24 (79.2%)0.66 (0.34, 1.30)Non-US/Canada127/205 (62.0%)147/208 (70.7%)0.81 (0.64, 1.03)Measurable disease Yes124/193 (64.2%)143/196 (73.0%)0.76 (0.60, 0.97)No19/37 (51.4%)23/36 (63.9%)0.99 (0.53, 1.82)ER-positive and PgR-positive Yes103/175 (58.9%)127/179 (70.9%)0.73 (0.56, 0.94)No40/55 (72.7%)39/53 (73.6%)1.04 (0.67, 1.62)Bisphosphonate use at baseline Yes44/61 (72.1%)53/62 (85.5%)0.69 (0.46, 1.03)No99/169 (58.6%)113/170 (66.5%)0.82 (0.63, 1.07)Visceral disease Yes92/135 (68.1%)87/119 (73.1%)0.99 (0.74, 1.33)No51/95 (53.7%)79/113 (69.9%)0.59 (0.42, 0.84)ªData for Asia/non-Asia subgroups are presented in a separate abstract Citation Format: Robertson JFR, Noguchi S, Shao Z, Grinsted LM, Fazal M, Ellis MJ. Progression-free survival results in patient subgroups from a Phase 3 randomized trial of fulvestrant 500 mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-08-02.
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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 | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,001 | 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 ».