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Are PIK3CA mutations associated with advanced breast cancer?
What are PIK3CA mutations?
Do PI3K mutations occur in HER2-negative breast cancer?
Are PIK3CA mutations associated with endocrine-resistant tumors?
Are PIK3CA mutations associated with decreased benefit to neoadjuvant human epidermal growth factor receptor 2?
Are PIK3CA mutations a negative prognostic value?
3 days ago · 2m 23s. Activating mutations in PIK3CA occur in approximately 35 to 40% of hormone receptor–positive breast cancers. 1-4 The presence of such mutations is a poor prognostic factor in patients ...
- Alpelisib for PIK3CA -Mutated, Hormone Receptor–Positive ...
PIK3CA mutations occur in approximately 40% of patients with...
- Alpelisib for PIK3CA -Mutated, Hormone Receptor–Positive ...
May 31, 2024 · PI3K inhibitors have conveyed promising results in the treatment of patients with endocrine-resistant breast cancer. Assessing PIK3CA mutations is highly relevant, and an improved outcome has...
- Systematic Literature Review Process
- Inclusion Criteria
- Exclusion Criteria
- Feasibility Assessment and Data Extraction
- Outcome Measures
- Analysis Variables
- Statistical Analysis
A systematic literature review was conducted by searching the MEDLINE and MEDLINE In-Process, EMBASE, Cochrane databases, and the Database for Abstracts of Reviews of Effects, for articles published from January 1993 to April 2019 . Additional manual searches to complement the electronic search were conducted until April 2022. All databases were se...
Studies were eligible for inclusion if they were conducted in human subjects or with human tissue, included post-menopausal women with HR + /HER2- mBC, contained information on the presence of PIK3CA mutation, included patients treated with monotherapy or combination therapy, reported PIK3CA mutation status among the HR + /HER2- subgroup, and repor...
As the objective of this meta-analysis was to identify the prognostic value of PIK3CA mutation in the absence of PI3K-targeted therapies, trial arms that included PI3K-targeted therapies (alpelisib, buparlisib, taselisib, and pictilisib) were excluded from the analysis. Data from non-PI3K -targeted comparator arms remained included. Additionally, r...
Publications identified in the systematic literature review were assessed for their suitability in terms of data availability and clinical relevance for inclusion in the meta-analysis. Summaries of trial characteristics (e.g., sample size, study design, follow-up, key inclusion and exclusion criteria, prior therapies), baseline characteristics (e.g...
The outcomes of interest in this study were PFS, defined as the time from randomization until objective disease progression (all included trials used RECIST v1.0 or v1.1) or death, and OS, defined as the time from randomization until death from any cause. PFS and OS were extracted as the median time to event (point estimates and associated 95% conf...
Binary variables (e.g., PIK3CA mutation status) were extracted as frequencies and percentages at the study level, whereas continuous variables (e.g., follow-up time) were extracted as means or medians with standard errors where available.
Meta-analyses
A meta-regression analysis was used to estimate the association between PIK3CA mutation status and PFS (median PFS and 6-, 12-, and 18-month PFS rates) or median OS across included studies (see Sect. 5 of the Supplemental Materials Table S2-S9 for detailed results). A multi-level mixed-effects model was used, with study-level random intercepts and random coefficients on PIK3CA status to capture the heterogeneity in effect sizes due to differences not explained by meta-regression factors ....
Model specifications
PIK3CA mutation status was studied as the primary exposure variable in the meta-regression model. Median PFS and OS times were studied on a linear scale and PFS rates at 6-, 12-, and 18-months were studied on a logit scale. These models, without further adjustment for arm- or trial-level factors, were studied as the primary analysis for each outcome. For OS data, limited data availability prevented further analyses. For PFS data, meta-regression adjustments were used to explore potential conf...
In the pivotal phase III randomized trial SOLAR-1 that confirmed the predictive value of PIK3CA-mutation status on the clinical benefit of the PI3K-α-selective inhibitor alpelisib in PIK3CA-mutated patients with HR + /HER2- advanced or metastatic BC [8, 9, 38], the vast majority of PIK3CA mutations were determined at the primary tumor (77%) rather than at the metastatic sites (22%) , whereas ...
May 15, 2019 · PIK3CA mutations occur in approximately 40% of patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer. The PI3Kα-specific...
- Fabrice André, Eva Ciruelos, Gabor Rubovszky, Mario Campone, Sibylle Loibl, Hope S Rugo, Hiroji Iwat...
- 2019
Mar 31, 2022 · Somatic activating mutations in the gene encoding PI3K alpha catalytic subunit (PIK3CA) are present in approximately 30% of early-stage HER2+ tumors and drive therapeutic resistance to multiple HER2-targeted agents.
May 31, 2024 · The presence of PIK3CA mutations was significantly associated with nodal involvement and mutations were more frequent in relapse than primary tumors. Our study shows the different PIK3CA mutations in endocrine-resistant BC and their fluctuations during therapy.
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