PI3K mutations detected in liquid biopsy are associated to reduced sensitivity to CDK4/6 inhibitors in metastatic breast cancer patients.


Journal

Pharmacological research
ISSN: 1096-1186
Titre abrégé: Pharmacol Res
Pays: Netherlands
ID NLM: 8907422

Informations de publication

Date de publication:
01 2021
Historique:
received: 31 07 2020
revised: 02 10 2020
accepted: 02 10 2020
pubmed: 14 10 2020
medline: 19 11 2021
entrez: 13 10 2020
Statut: ppublish

Résumé

PI3K pathway hyperactivation due to PIK3CA mutations contributes to endocrine resistance, and PIK3CA is one of the most frequently mutated genes in breast cancer (BC), occurring approximately 40 % of HR+, HER2- advanced BC (ABC). Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) have changed the treatment landscape of HR+, HER2- ABC. Putative mechanisms of resistance to CDK4/6i have been identified, but limited data are available on PI3K deregulation. The present study evaluates the impact of PIK3CA mutations on CDK4/6i plus hormone therapy and evaluates potential characteristics that may suggest for a PI3K screening in patients with ABC. ABC patients were enrolled, and 12 mL of blood were collected in EDTA tubes at baseline prior to CDK4/6i plus hormone therapy. Plasma was separated and circulating free DNA (cfDNA) was extracted. PIK3CA mutation analysis was performed on a ddPCR. Selected and analyzed mutations included: p.C420R, p.E542 K, p.E545A, p.E545D, p.E545G, p.E545K, p.Q546E, p.Q546R, p.H1047L, p.H1047R, p.H1047Y. Statistical analysis were performed to investigate the predictive power of such mutations and any association with clinical factors. Thirty patients were enrolled. PIK3CA mutation status at baseline was independently associated with shorter median PFS (7.44 vs 12.9 months, p = 0.01) in subject receiving CDK4/6i plus hormone therapy. PIK3CA mutations were found to be associated to Ki67 expression in primary lesions (p = 0.006). Moreover, the probability to find a PI3K mutation improved considering also the therapeutic management in previous lines of treatment (McFadden's R The findings of this pilot study suggest that the presence of a PI3K mutation in liquid biopsy correlates with a worse PFS in patients with ABC receiving CDK4/6i, and that liquid biopsy is a useful tool to suggests a better tailored pharmacological intervention.

Sections du résumé

BACKGROUND
PI3K pathway hyperactivation due to PIK3CA mutations contributes to endocrine resistance, and PIK3CA is one of the most frequently mutated genes in breast cancer (BC), occurring approximately 40 % of HR+, HER2- advanced BC (ABC). Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) have changed the treatment landscape of HR+, HER2- ABC. Putative mechanisms of resistance to CDK4/6i have been identified, but limited data are available on PI3K deregulation. The present study evaluates the impact of PIK3CA mutations on CDK4/6i plus hormone therapy and evaluates potential characteristics that may suggest for a PI3K screening in patients with ABC.
METHODS
ABC patients were enrolled, and 12 mL of blood were collected in EDTA tubes at baseline prior to CDK4/6i plus hormone therapy. Plasma was separated and circulating free DNA (cfDNA) was extracted. PIK3CA mutation analysis was performed on a ddPCR. Selected and analyzed mutations included: p.C420R, p.E542 K, p.E545A, p.E545D, p.E545G, p.E545K, p.Q546E, p.Q546R, p.H1047L, p.H1047R, p.H1047Y. Statistical analysis were performed to investigate the predictive power of such mutations and any association with clinical factors.
RESULTS
Thirty patients were enrolled. PIK3CA mutation status at baseline was independently associated with shorter median PFS (7.44 vs 12.9 months, p = 0.01) in subject receiving CDK4/6i plus hormone therapy. PIK3CA mutations were found to be associated to Ki67 expression in primary lesions (p = 0.006). Moreover, the probability to find a PI3K mutation improved considering also the therapeutic management in previous lines of treatment (McFadden's R
CONCLUSION
The findings of this pilot study suggest that the presence of a PI3K mutation in liquid biopsy correlates with a worse PFS in patients with ABC receiving CDK4/6i, and that liquid biopsy is a useful tool to suggests a better tailored pharmacological intervention.

Identifiants

pubmed: 33049397
pii: S1043-6618(20)31549-8
doi: 10.1016/j.phrs.2020.105241
pii:
doi:

Substances chimiques

Antineoplastic Agents 0
Class I Phosphatidylinositol 3-Kinases EC 2.7.1.137
PIK3CA protein, human EC 2.7.1.137
CDK4 protein, human EC 2.7.11.22
CDK6 protein, human EC 2.7.11.22
Cyclin-Dependent Kinase 4 EC 2.7.11.22
Cyclin-Dependent Kinase 6 EC 2.7.11.22

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105241

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

Auteurs

Marzia Del Re (M)

Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Stefania Crucitta (S)

Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Giulia Lorenzini (G)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Claudia De Angelis (C)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Lucrezia Diodati (L)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Diletta Cavallero (D)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Irene Bargagna (I)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Paola Cinacchi (P)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Beatrice Fratini (B)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Barbara Salvadori (B)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Matteo Ghilli (M)

Unit of Breast Surgery, Breast Cancer Center, University Hospital of Pisa, Italy.

Manuela Roncella (M)

Unit of Breast Surgery, Breast Cancer Center, University Hospital of Pisa, Italy.

Andrea Fontana (A)

Unit of Medical Oncology, Department of Translational Research and New Technologies in Medicine, University of Pisa, Italy.

Romano Danesi (R)

Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, Italy. Electronic address: romano.danesi@unipi.it.

Federico Cucchiara (F)

Unit of Clinical Pharmacology and Pharmacogenetics, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

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Classifications MeSH