Safety and Efficacy of RAD001 (Everolimus) Administered Upon Relapse During or After Adjuvant Treatment in Post-menopausal Women With Hormone Receptor Positive, HER2/neu Negative Locally Advanced or Metastatic Breast Cancer (CRAD001JGR08 "MELPOMENI" study).
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Breast Neoplasms
/ drug therapy
Chemotherapy, Adjuvant
Disease Progression
Drug Administration Schedule
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Everolimus
/ administration & dosage
Female
Greece
/ epidemiology
Humans
Middle Aged
Neoplasm Metastasis
Neoplasm Recurrence, Local
/ drug therapy
Postmenopause
Receptor, ErbB-2
/ metabolism
Receptors, Estrogen
/ metabolism
Receptors, Progesterone
/ metabolism
Survival Analysis
Treatment Outcome
Advanced breast cancer
effectiveness
everolimus
first line
safety
Journal
Anticancer research
ISSN: 1791-7530
Titre abrégé: Anticancer Res
Pays: Greece
ID NLM: 8102988
Informations de publication
Date de publication:
Feb 2022
Feb 2022
Historique:
received:
29
11
2021
revised:
14
12
2021
accepted:
15
12
2021
entrez:
30
1
2022
pubmed:
31
1
2022
medline:
5
2
2022
Statut:
ppublish
Résumé
This study aimed to provide real-world safety and effectiveness data of everolimus (EVE) plus exemestane (EXE) in estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER This prospective observational study was conducted by 19 hospital-based oncologists in Greece. Eligible patients were treated with EVE+EXE in the first-line setting; EVE was initiated according to the approved label. Overall, 75 eligible patients (mean age: 66.9 years; visceral metastases: 49.3%; bone-only metastases: 37.3%) were included in the effectiveness analyses. Over a median (interquartile range) of 12.1 months (range=4.2-20.5 months) of EVE treatment, the median progression-free survival was 18.0 months and the overall response rate was 22.7%. Among patients that received ≥1 EVE dose (n=80), the incidence of EVE-related adverse events was 72.5% (serious: 55.0%); stomatitis (22.5%), fatigue (22.5%), pneumonitis (18.8%); and cough (18.8%) were the most common. In the routine care in Greece, EVE demonstrates clinical benefit and a predictable safety profile.
Sections du résumé
BACKGROUND/AIM
OBJECTIVE
This study aimed to provide real-world safety and effectiveness data of everolimus (EVE) plus exemestane (EXE) in estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER
PATIENTS AND METHODS
METHODS
This prospective observational study was conducted by 19 hospital-based oncologists in Greece. Eligible patients were treated with EVE+EXE in the first-line setting; EVE was initiated according to the approved label.
RESULTS
RESULTS
Overall, 75 eligible patients (mean age: 66.9 years; visceral metastases: 49.3%; bone-only metastases: 37.3%) were included in the effectiveness analyses. Over a median (interquartile range) of 12.1 months (range=4.2-20.5 months) of EVE treatment, the median progression-free survival was 18.0 months and the overall response rate was 22.7%. Among patients that received ≥1 EVE dose (n=80), the incidence of EVE-related adverse events was 72.5% (serious: 55.0%); stomatitis (22.5%), fatigue (22.5%), pneumonitis (18.8%); and cough (18.8%) were the most common.
CONCLUSION
CONCLUSIONS
In the routine care in Greece, EVE demonstrates clinical benefit and a predictable safety profile.
Identifiants
pubmed: 35093904
pii: 42/2/1031
doi: 10.21873/anticanres.15564
doi:
Substances chimiques
Receptors, Estrogen
0
Receptors, Progesterone
0
Everolimus
9HW64Q8G6G
Receptor, ErbB-2
EC 2.7.10.1
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1031-1041Informations de copyright
Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.