Abstract P4-22-06: Treatment postprogression in women with endocrine-resistant HR+/HER2- advanced breast cancer who received palbociclib plus fulvestrant in PALOMA-3
Notice bibliographique
Résumé
Abstract Background: Palbociclib (PAL) plus fulvestrant (FUL) demonstrated significant improvement in progression-free survival (PFS) vs placebo (PBO) plus FUL in women with HR+/HER2- advanced breast cancer (ABC) whose disease had progressed on prior endocrine therapy (ET). Because the effectiveness of standard therapies after progression on PAL is unknown, it is important to understand whether the benefits of PAL with respect to PFS extend to subsequent treatments. Method: Pre-, peri-, and postmenopausal patients (pts) with HR+/HER2- ABC who had relapsed/progressed on prior ET were randomized 2:1 to PAL (125 mg/d oral [3 wk on drug, 1 wk off]) + FUL (500 mg/mo intramuscular, per standard of care) or PBO+FUL. One prior line of chemotherapy (CT) for ABC was allowed. For 9 mo immediately after participation in PALOMA-3, pts were assessed every 3 mo for information on poststudy progression and treatment; the type of treatment, its duration, and sites of progression were analyzed. Results: As of Oct 2015, with a median follow-up of 15.8 mo for PAL+FUL and 15.3 mo for PBO+FUL, 333 PFS events were observed (200 and 133, respectively). Median PFS was 11.2 vs 4.6 mo (hazard ratio [HR], 0.497 [95% CI, 0.398–0.620]; P<0.0001). In both treatment arms, the most common sites of disease progression were the liver (149 [43%] and 94 [54%]) and bone (55 [16%] and 43 [25%]). 1 pt in each treatment arm developed new brain metastasis. The most commonly used postprogression regimens were capecitabine (n=57 [28.8%]), paclitaxel (n=22 [11.1%]), and exemestane (n=34 [17.2%]). Median time to subsequent CT (from randomization to the start of the first CT treatment poststudy) was longer with PAL+FUL (252 d) than with PBO+FUL (132 d). This was also observed in pts with visceral disease who never received CT in the advanced setting at study entry (median 208 and 125 d, respectively). 252 pts had subsequent disease progression, treatment discontinuation on immediate subsequent therapy, or died. Proportionally fewer pts in the PAL+FUL vs PBO+FUL arm discontinued next-line treatment (33% vs 46%), indicating that PAL does not adversely affect the efficacy of subsequent treatments. Analysis of the time to end of next-line treatment showed that the HR between the 2 treatment arms was 0.623 ([95% CI, 0.482–0.805]; 1-sided P value=0.0001) in favor of PAL treatment (Table 1). Conclusion: The current analysis demonstrated that the treatment effect of PAL+FUL was retained in the most immediate line postprogression and that progression after PAL has no effect on the therapeutic benefit from subsequent treatments. Sponsor: Pfizer Table 1. PAL+FUL (n=347)PBO+FUL (n=174)Pts who progressed and were eligible for subsequent therapy, n (%)198 (57)130 (75)Pt with postprogression event, n (%)156 (45)96 (55)Objective progression on next-line therapy, n (%)15 (4)5 (3)Deaths, n (%)28 (8)11 (6)End of next-line therapy, n (%)113 (33)80 (46)Median (95% CI) probability of being event-free at 12 mo69.2 (64.0–73.8)54.4 (46.4–61.7)Median (95% CI) time to end of next-line therapy, mo17.9 (16.0–NR)12.8 (11.0–14.6)Hazard ratio (95% CI)0.623 (0.482–0.805)P value0.0001FUL=fulvestrant; NR=not reached; PAL=palbociclib; PBO=placebo. Citation Format: Turner NC, André F, Cristofanilli M, Verma S, Iwata H, Loi S, Harbeck N, Ro J, Colleoni M, Zhang K, Huang Bartlett C, Giorgetti C, Slamon D. Treatment postprogression in women with endocrine-resistant HR+/HER2- advanced breast cancer who received palbociclib plus fulvestrant in PALOMA-3 [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 P4-22-06.
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 | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| 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) | 0,001 | 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 ».