Prognostic role of serum thymidine kinase 1 activity in patients with hormone receptor-positive metastatic breast cancer: Analysis of the randomised phase III Evaluation of Faslodex versus Exemestane Clinical Trial (EFECT).


Journal

European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373

Informations de publication

Date de publication:
06 2019
Historique:
received: 12 12 2018
revised: 28 03 2019
accepted: 02 04 2019
pubmed: 7 5 2019
medline: 30 5 2020
entrez: 7 5 2019
Statut: ppublish

Résumé

Thymidine kinase 1 (TK1) plays a critical role in DNA synthesis and cell proliferation. Recent studies have shown potential for serum TK1 activity (sTKa) as a prognostic marker and indicator of early response to endocrine therapy in advanced breast cancer. The aim of this study is to assess the correlation between sTKa and patient outcome. The Evaluation of Faslodex versus Exemestane Clinical Trial (EFECT) was a double-blind, double-dummy, randomised trial of fulvestrant versus exemestane after progression on non-steroidal aromatase inhibitor therapy, in postmenopausal women with advanced breast cancer. Retrospective analyses of serum archived from EFECT were conducted. sTKa was assessed using the DiviTum® assay on samples collected at baseline, after three and six months of endocrine therapy, and at disease progression. The median time to progression (mTTP) for patients with low baseline sTKa levels was 5.03 months (95% confidence interval [CI]: 3.91-5.89) versus 2.57 months (95% CI: 2.04-3.52) in patients with high sTKa baseline levels (P < 0.0001). On treatment, patients whose sTKa increased from baseline had a significantly shorter mTTP (3.39 months, 95% CI: 2.14-4.11) than those without an sTKa increase (5.39 months, 95% CI: 4.01-6.68) (P = 0.0045). Similar results were observed in the separate EFECT treatment arms. After adjusting for major prognostic factors, sTKa remained an independent marker. sTKa is a potential circulating prognostic marker in patients with advanced breast cancer treated with endocrine therapy. It may also represent a tool for upfront identification of endocrine therapy resistance and early positive response to therapy. Independent validation of these results is warranted.

Sections du résumé

BACKGROUND
Thymidine kinase 1 (TK1) plays a critical role in DNA synthesis and cell proliferation. Recent studies have shown potential for serum TK1 activity (sTKa) as a prognostic marker and indicator of early response to endocrine therapy in advanced breast cancer. The aim of this study is to assess the correlation between sTKa and patient outcome.
PATIENTS AND METHODS
The Evaluation of Faslodex versus Exemestane Clinical Trial (EFECT) was a double-blind, double-dummy, randomised trial of fulvestrant versus exemestane after progression on non-steroidal aromatase inhibitor therapy, in postmenopausal women with advanced breast cancer. Retrospective analyses of serum archived from EFECT were conducted. sTKa was assessed using the DiviTum® assay on samples collected at baseline, after three and six months of endocrine therapy, and at disease progression.
RESULTS
The median time to progression (mTTP) for patients with low baseline sTKa levels was 5.03 months (95% confidence interval [CI]: 3.91-5.89) versus 2.57 months (95% CI: 2.04-3.52) in patients with high sTKa baseline levels (P < 0.0001). On treatment, patients whose sTKa increased from baseline had a significantly shorter mTTP (3.39 months, 95% CI: 2.14-4.11) than those without an sTKa increase (5.39 months, 95% CI: 4.01-6.68) (P = 0.0045). Similar results were observed in the separate EFECT treatment arms. After adjusting for major prognostic factors, sTKa remained an independent marker.
CONCLUSION
sTKa is a potential circulating prognostic marker in patients with advanced breast cancer treated with endocrine therapy. It may also represent a tool for upfront identification of endocrine therapy resistance and early positive response to therapy. Independent validation of these results is warranted.

Identifiants

pubmed: 31059974
pii: S0959-8049(19)30223-0
doi: 10.1016/j.ejca.2019.04.002
pii:
doi:

Substances chimiques

Androstadienes 0
Antineoplastic Agents 0
Fulvestrant 22X328QOC4
Thymidine Kinase EC 2.7.1.21
thymidine kinase 1 EC 2.7.1.21
exemestane NY22HMQ4BX

Types de publication

Clinical Trial, Phase III Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

55-66

Informations de copyright

Copyright © 2019 Elsevier Ltd. All rights reserved.

Auteurs

Amelia McCartney (A)

"Sandro Pitigliani" Medical Oncology Department, Hospital of Prato, Prato, Italy.

Chiara Biagioni (C)

"Sandro Pitigliani" Medical Oncology Department, Hospital of Prato, Prato, Italy; Bioinformatics Unit, Hospital of Prato, Prato, Italy.

Gaia Schiavon (G)

IMED Biotech Unit, AstraZeneca, Cambridge, UK.

Mattias Bergqvist (M)

Biovica International, Uppsala, Sweden.

Karin Mattsson (K)

Biovica International, Uppsala, Sweden.

Ilenia Migliaccio (I)

Translational Research Unit, Hospital of Prato, Prato, Italy.

Matteo Benelli (M)

Bioinformatics Unit, Hospital of Prato, Prato, Italy.

Dario Romagnoli (D)

Bioinformatics Unit, Hospital of Prato, Prato, Italy.

Martina Bonechi (M)

Translational Research Unit, Hospital of Prato, Prato, Italy.

Giulia Boccalini (G)

Translational Research Unit, Hospital of Prato, Prato, Italy.

Marta Pestrin (M)

"Sandro Pitigliani" Medical Oncology Department, Hospital of Prato, Prato, Italy; Translational Research Unit, Hospital of Prato, Prato, Italy.

Francesca Galardi (F)

Translational Research Unit, Hospital of Prato, Prato, Italy.

Francesca De Luca (F)

Translational Research Unit, Hospital of Prato, Prato, Italy.

Laura Biganzoli (L)

"Sandro Pitigliani" Medical Oncology Department, Hospital of Prato, Prato, Italy.

Martine Piccart (M)

Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.

William J Gradishar (WJ)

Department of Medicine, Northwestern University, Chicago, IL, USA.

Stephen Chia (S)

Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, BC, Canada.

Angelo Di Leo (A)

"Sandro Pitigliani" Medical Oncology Department, Hospital of Prato, Prato, Italy.

Luca Malorni (L)

"Sandro Pitigliani" Medical Oncology Department, Hospital of Prato, Prato, Italy; Translational Research Unit, Hospital of Prato, Prato, Italy. Electronic address: luca.malorni@uslcentro.toscana.it.

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Classifications MeSH