Treatment patterns and clinical outcomes among patients receiving palbociclib in combination with an aromatase inhibitor or fulvestrant for HR+/HER2-negative advanced/metastatic breast cancer in real-world settings in the US: Results from the IRIS study.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Aromatase Inhibitors
/ administration & dosage
Bone Neoplasms
/ drug therapy
Brain Neoplasms
/ drug therapy
Breast Neoplasms
/ drug therapy
Female
Fulvestrant
/ administration & dosage
Humans
Liver Neoplasms
/ drug therapy
Lung Neoplasms
/ drug therapy
Middle Aged
Neoplasm Staging
Piperazines
/ administration & dosage
Practice Patterns, Physicians'
Pyridines
/ administration & dosage
Receptors, Estrogen
/ metabolism
Receptors, Progesterone
/ metabolism
Treatment Outcome
Breast cancer
ClinicalTrials.gov
Medical chart review
NCT03159195
Palbociclib
Real-world
Retrospective
Journal
Breast (Edinburgh, Scotland)
ISSN: 1532-3080
Titre abrégé: Breast
Pays: Netherlands
ID NLM: 9213011
Informations de publication
Date de publication:
Feb 2019
Feb 2019
Historique:
received:
05
08
2018
revised:
17
10
2018
accepted:
19
10
2018
pubmed:
6
11
2018
medline:
29
5
2019
entrez:
5
11
2018
Statut:
ppublish
Résumé
Palbociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor approved for use in postmenopausal women with hormone receptor-positive, human epidermal growth factor 2-negative (HR+/HER2-) advanced/metastatic breast cancer (ABC/MBC). Palbociclib has proven benefits in phase III placebo-controlled studies; however, real-world outcome data are lacking. The Ibrance Real World Insights (IRIS) study evaluated palbociclib use in patients with HR+/HER2- ABC/MBC in the real-world setting in the US, Argentina, and Germany. Here we describe results for the US patient subgroup. IRIS was a retrospective medical chart review study of patients with confirmed HR+/HER2- ABC/MBC who received palbociclib with either an aromatase inhibitor (AI) as initial endocrine-based therapy in postmenopausal women or fulvestrant-based therapy in women with disease progression following endocrine therapy. Physicians extracted data from patient medical records for ≤16 sequential patients each. Outcomes included progression-free and survival rates. Records were extracted for 652 patients: 360 (55.2%) treated with palbociclib + AI and 292 (44.8%) treated with palbociclib + fulvestrant. The 12-month progression-free rate was 84.1% for patients treated with palbociclib + AI and 79.8% for those treated with palbociclib + fulvestrant; 12-month survival rates were 95.1% for palbociclib + AI and 87.9% for palbociclib + fulvestrant. In this first real-world assessment of clinical outcomes in US patients with HR+/HER- ABC/MBC, treatment with palbociclib in combination with AI or fulvestrant demonstrated favorable effectiveness in terms of progression-free and survival rates. Ongoing studies are needed to deliver mature clinical outcome data beyond 12/24 months in the real-world setting.
Identifiants
pubmed: 30391832
pii: S0960-9776(18)30316-3
doi: 10.1016/j.breast.2018.10.009
pii:
doi:
Substances chimiques
Aromatase Inhibitors
0
Piperazines
0
Pyridines
0
Receptors, Estrogen
0
Receptors, Progesterone
0
Fulvestrant
22X328QOC4
palbociclib
G9ZF61LE7G
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
22-27Informations de copyright
Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.