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Integrating PIK3CA Testing into Clinical Practice for Advanced HR+/HER2- Breast Cancer: An Expert Consensus
Carmine De Angelis1, Dario de Biase2, Lorenzo Gerratana3
1Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Via Mariano Semmola, 52, Napoli 80131, Italy; Clinical and Translational Oncology, Scuola Superiore Meridionale, Naples, Italy.
Background:
Alterations in the PI3K/AKT/mTOR signaling pathway represent a mechanism of resistance to endocrine therapy in advanced HR+/HER2-breast cancer. The identification of activating mutations in PIK3CA has gained therapeutic relevance, guiding the use of PIK3CA-targeted inhibitors such as alpelisib and inavolisib.
Methods:
A multidisciplinary panel of Italian experts conducted a structured consensus process to develop shared recommendations for molecular testing of PIK3CA in advanced HR+/HER2-breast cancer, addressing preanalytical, analytical, and clinical-therapeutic areas of concern.
Results:
A total of 23 out of 29 statements reached complete agreement (100%). The resulting recommendations encompass sample selection, analytical methodologies, sensitivity thresholds, result reporting, and clinical interpretation and integration. Additional guidance is provided for the management of non-canonical gene variants and for other genes involved in the PI3K/AKT/mTOR pathway.
Conclusions:
This consensus document provides operational and interpretative guidelines aimed at standardizing PIK3CAtesting and assessing related genes in clinical practice. These recommendations promote a harmonized approach to patient care, in line with the latest scientific evidence.
Insights
Standardizing PIK3CA testing is crucial for advanced HR+/HER2- breast cancer patients. This consensus provides guidelines for molecular testing, improving endocrine therapy resistance management.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genetics
Background:
- PI3K/AKT/mTOR pathway alterations drive endocrine therapy resistance in HR+/HER2- breast cancer.
- Activating PIK3CA mutations are key therapeutic targets for inhibitors like alpelisib and inavolisib.
Purpose of the Study:
- To establish shared recommendations for molecular testing of PIK3CA in advanced HR+/HER2- breast cancer.
- To address preanalytical, analytical, and clinical-therapeutic aspects of PIK3CA testing.
Main Methods:
- A multidisciplinary panel of Italian experts convened for a structured consensus process.
- Recommendations were developed covering various stages of molecular testing and clinical integration.
Main Results:
- 23 out of 29 statements achieved full consensus (100% agreement).
- Recommendations cover sample selection, analytical methods, sensitivity, reporting, and interpretation.
- Guidance is offered for non-canonical variants and other PI3K/AKT/mTOR pathway genes.
Conclusions:
- This consensus provides operational and interpretative guidelines for PIK3CA testing and related gene assessment.
- The recommendations aim to standardize testing and promote a harmonized approach to patient care.
- The guidelines align with the latest scientific evidence in breast cancer treatment.
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