First prospective outcome data for the second-generation multigene test Endopredict in ER-positive/HER2-negative breast cancer.
Adult
Aged
Antineoplastic Agents, Hormonal
/ therapeutic use
Breast Neoplasms
/ drug therapy
Chemotherapy, Adjuvant
Disease-Free Survival
Family Characteristics
Female
Humans
Kaplan-Meier Estimate
Middle Aged
Neoplasm Recurrence, Local
/ drug therapy
Predictive Value of Tests
Prognosis
Proportional Hazards Models
Prospective Studies
Real-Time Polymerase Chain Reaction
Receptor, ErbB-2
/ metabolism
Receptors, Estrogen
/ metabolism
Treatment Outcome
Adjuvant chemotherapy
Breast cancer
Endocrine therapy
Endopredict
Predictive biomarker
Prognostic biomarker
Journal
Archives of gynecology and obstetrics
ISSN: 1432-0711
Titre abrégé: Arch Gynecol Obstet
Pays: Germany
ID NLM: 8710213
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
06
07
2020
accepted:
24
08
2020
pubmed:
10
9
2020
medline:
22
1
2021
entrez:
9
9
2020
Statut:
ppublish
Résumé
Prospectively collected outcome data of patients (pts) whose adjuvant systemic therapy recommendation was based on the clinico-molecular test EndoPredict Pts with ER-positive, HER2-negative early breast cancer with 0-3 positive lymph nodes were enrolled. The EP was carried out on all tumor samples. Pts were evaluated for treatment compliance, local recurrence, distant metastases and overall survival. Censored time-to-event outcomes were analysed by Cox proportional hazards models. Additional estimates of the event-free-survival were calculated by the Kaplan-Meier method. Hypothesis testing was conducted on two-sided exploratory 5% significance levels. 373 consecutive pts were enrolled. EP classified 238 pts (63.8%) as low risk and 135 pts (36.2%) as high risk. Median follow-up was 41.6 months. Risk for disease recurrence or death in EPclin high-risk patients was twofold higher in comparison with EPclin low-risk patients (hazard ratio (HR) 2.05 (95% CI 0.85-4.96; p = 0.110). Patients with EPclin high risk were at significant higher risk of distant metastases than patients with EPclin low risk (HR 5.18; 95% CI 1.04-25.74; p = 0.0443). EPclin high-risk patients who actually underwent adjuvant CTX had a 3-year-DFS of 96.3% (95% CI 92.2-100) in contrast to EPclin high-risk patients without CTX (3-year-DFS: 91.5% (95% CI 82.7-100%); HR 0.32; 95% CI 0.10-1.05; p = 0.061). These first prospective outcome results show that EP, in clinical routine, is a valid clinico-molecular test, to predict DFS and to guide decision of adjuvant CTX use in ER-positive, HER2-negative early breast cancer pts with 0-3 positive lymph nodes. Adjuvant CTX seems to be beneficial for EPclin high-risk patients.
Identifiants
pubmed: 32902674
doi: 10.1007/s00404-020-05771-4
pii: 10.1007/s00404-020-05771-4
pmc: PMC7584549
doi:
Substances chimiques
Antineoplastic Agents, Hormonal
0
Receptors, Estrogen
0
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1461-1467Références
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