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[Expert consensus on detection and clinical application of alterations in PIK3CA/AKT1/PTEN genes (2026 edition)].

Created on 26 Oct 2026

Authors

Breast Cancer Expert Committee of China Anti-Cancer Association, Society of Tumor Pathology of China Anti-Cancer Association, Breast Cancer Expert Committee of National Cancer Quality Control Center

Published in

Zhonghua zhong liu za zhi [Chinese journal of oncology]. Volume 48. Issue 10. Pages 1194-1212. Oct 23, 2026.

Abstract

Breast cancer is the most common malignancy among women worldwide, with a continuously increasing incidence, posing a major public health threat to women's health. In recent years, with advances in molecular biology and innovations in diagnostic and therapeutic technologies, the management of breast cancer has evolved from histopathological classification to an era of individualized precision medicine guided by molecular characteristics. PIK3CA/AKT1/PTEN alterations represent one of the key mechanisms underlying resistance to endocrine therapy, CDK4/6 inhibitors, and anti-HER-2 therapies in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER-2-) breast cancer. Data from China indicate that approximately 60% of patients with breast cancer harbor genetic alterations in PI3K/AKT pathway. Multiple agents targeting these alterations have been approved domestically and internationally, including the AKT inhibitor capivasertib and the PI3K inhibitors inavolisib and alpelisib, which have significantly improved survival outcomes in patients with corresponding genomic alterations. To standardize testing procedures and guide the rational use of targeted therapies, the Breast Cancer Expert Committee of China Anti-Cancer Association, the Society of Tumor Pathology of China Anti-Cancer Association, and the Breast Cancer Expert Committee of the National Cancer Quality Control Center jointly led a multidisciplinary panel of experts from breast surgery, medical oncology, pathology, pharmacy, and related fields to develop this consensus based on systematic literature searches of PubMed, Embase, the Cochrane Library, as well as Chinese databases such as CNKI and Wanfang, and guided by the GRADE evidence grading system. This consensus comprehensively addresses the clinical significance of PIK3CA/AKT1/PTEN testing, technical specifications, therapeutic decision-making, adverse event management, and future research directions. It aims to provide a standardized framework for clinical practice and institutional workflow in this field, offering practical guidance for clinicians, pathologists, and healthcare institutions, and ultimately maximizing the benefits of precision medicine for patients with breast cancer.

PMID:
42927945
Bibliographic data and abstract were imported from PubMed on 26 Oct 2026.

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