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    1. karim2001khoury 19 Feb 2026
      Correlation between PIK3CA mutations in cell-free DNA and everolimus efficacy in HR+, HER2− advanced breast cancer: results from BOLERO-2

      [Paper-level Aggregated] PMCID: PMC5355930

      Evidence Type(s): Predictive, Prognostic, Oncogenic

      Justification: Predictive: The text indicates that the presence of PIK3CA mutations, specifically H1047R, E545K, and E542K, is associated with different progression-free survival (PFS) outcomes in patients treated with everolimus, suggesting these mutations can predict treatment efficacy. Prognostic: The analysis shows that patients with E545K/E542K mutations had shorter PFS and overall survival compared to those with wild-type PIK3CA in the placebo arm, indicating these mutations may have prognostic implications regarding disease outcome. Oncogenic: The presence of PIK3CA mutations, including E542K, E545K, and H1047R, is associated with tumor behavior and treatment response, suggesting these mutations contribute to oncogenesis in the context of cancer.

      Gene→Variant (gene-first): PIK3CA(5290):E542K PIK3CA(5290):E545K PIK3CA(5290):H1047R

      Genes: PIK3CA(5290)

      Variants: E542K E545K H1047R

      CIViC paper-level aggregated PMC5355930
    2. karim2001khoury 19 Feb 2026
      Among 550 patients included in cfDNA analysis, median PFS in everolimus vs placebo arms was similar in patients with tumours that had wild-type or mutant PIK3CA (hazard ratio (HR), 0.43 and 0.37, respectively). Everolimu

      [Paragraph-level] PMCID: PMC5355930 Section: ABSTRACT PassageIndex: 6

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses the correlation between PIK3CA mutations (H1047R, E545K, E542K) and the response to the therapy everolimus, indicating that these variants are associated with treatment outcomes. Oncogenic: The mention of PIK3CA mutations in the context of tumor analysis suggests that these somatic variants contribute to tumor development or progression, particularly in relation to their response to therapy.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K 5290:H1047R

      Genes: 5290

      Variants: E542K E545K H1047R

      CIViC paragraph-level PMC5355930 Predictive Oncogenic
    3. karim2001khoury 19 Feb 2026
      PIK3CA H1047R, E545K, and E542K mutations in plasma-derived cfDNA were analysed by droplet digital PCR (ddPCR). Median PFS was estimated for patient subgroups defined by PIK3CA mutations in each treatment arm.

      [Paragraph-level] PMCID: PMC5355930 Section: ABSTRACT PassageIndex: 4

      Evidence Type(s): Diagnostic, Prognostic

      Justification: Diagnostic: The passage discusses the analysis of PIK3CA mutations to define patient subgroups, indicating that these variants are used to classify or associate with a disease or subtype. Prognostic: The mention of estimating median progression-free survival (PFS) for patient subgroups defined by PIK3CA mutations suggests a correlation with disease outcome independent of therapy.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K 5290:H1047R

      Genes: 5290

      Variants: E542K E545K H1047R

      CIViC paragraph-level PMC5355930 Diagnostic Prognostic
    4. karim2001khoury 19 Feb 2026
      In the placebo arm, patients with E545K/E542K mutation had shorter PFS and overall survival than those with wild-type PIK3CA (Supplementary Table 2), suggesting that PIK3CA mutations in the helical domain might play a ro

      [Paragraph-level] PMCID: PMC5355930 Section: RESULTS PassageIndex: 9

      Evidence Type(s): Predictive, Prognostic

      Justification: Predictive: The passage suggests that patients with E545K/E542K mutations had shorter progression-free survival (PFS) and overall survival, indicating a potential role of these mutations in resistance to hormone therapy. Prognostic: The mention of shorter PFS and overall survival in patients with the E545K/E542K mutations indicates a correlation with disease outcome independent of therapy.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K

      Genes: 5290

      Variants: E542K E545K

      CIViC paragraph-level PMC5355930 Predictive Prognostic
    5. karim2001khoury 19 Feb 2026
      To examine the role of domain-specific mutations in PIK3CA on everolimus efficacy, patients were categorised by mutation site, H1047R in the catalytic domain, and E545K and E542K in the helical domain. Everolimus prolong

      [Paragraph-level] PMCID: PMC5355930 Section: RESULTS PassageIndex: 8

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses the correlation between PIK3CA mutations (H1047R, E545K, E542K) and the efficacy of everolimus, indicating that these variants are associated with prolonged progression-free survival (PFS) in patients treated with this therapy. Oncogenic: The mention of PIK3CA mutations in the context of their role in tumor development and the efficacy of a cancer treatment suggests that these somatic variants contribute to tumor progression.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K 5290:H1047R

      Genes: 5290

      Variants: E542K E545K H1047R

      CIViC paragraph-level PMC5355930 Predictive Oncogenic
    6. karim2001khoury 19 Feb 2026
      Of the 724 patients in BOLERO-2, 550 patients (76%) underwent PIK3CA cfDNA analysis. The baseline characteristics and clinical outcomes were similar between the cfDNA and overall population (Supplementary Table 1). PIK3C

      [Paragraph-level] PMCID: PMC5355930 Section: RESULTS PassageIndex: 3

      Evidence Type(s): Diagnostic, Predictive

      Justification: Diagnostic: The passage discusses the prevalence of PIK3CA mutations, including specific variants, in a patient population, indicating their association with the disease context. Predictive: The mention of higher prevalence of PIK3CA mutations in the everolimus arm compared to the placebo arm suggests a correlation with treatment response, indicating predictive value.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K 5290:H1047R

      Genes: 5290

      Variants: E542K E545K H1047R

      CIViC paragraph-level PMC5355930 Diagnostic Predictive
    7. karim2001khoury 19 Feb 2026
      Among 550 patients included in cfDNA analysis, median PFS in everolimus vs placebo arms was similar in patients with tumours that had wild-type or mutant PIK3CA (hazard ratio (HR), 0.43 and 0.37, respectively). Everolimu

      [Paragraph-level] PMCID: PMC5355930 Section: ABSTRACT PassageIndex: 6

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses the correlation between PIK3CA mutations (H1047R, E545K, E542K) and the response to the therapy everolimus, indicating that these variants are associated with treatment outcomes. Oncogenic: The mention of PIK3CA mutations in the context of tumor analysis suggests that these somatic variants contribute to tumor development or progression, particularly in relation to their response to therapy.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K 5290:H1047R

      Genes: 5290

      Variants: E542K E545K H1047R

      CIViC paragraph-level PMC5355930 Predictive Oncogenic
    8. karim2001khoury 19 Feb 2026
      PIK3CA H1047R, E545K, and E542K mutations in plasma-derived cfDNA were analysed by droplet digital PCR (ddPCR). Median PFS was estimated for patient subgroups defined by PIK3CA mutations in each treatment arm.

      [Paragraph-level] PMCID: PMC5355930 Section: ABSTRACT PassageIndex: 4

      Evidence Type(s): Diagnostic, Prognostic

      Justification: Diagnostic: The passage discusses the analysis of PIK3CA mutations to define patient subgroups, indicating that these variants are used to classify or associate with a disease or subtype. Prognostic: The mention of estimating median progression-free survival (PFS) for patient subgroups defined by PIK3CA mutations suggests a correlation with disease outcome independent of therapy.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K 5290:H1047R

      Genes: 5290

      Variants: E542K E545K H1047R

      CIViC paragraph-level PMC5355930 Diagnostic Prognostic
    9. karim2001khoury 19 Feb 2026
      In the placebo arm, patients with E545K/E542K mutation had shorter PFS and overall survival than those with wild-type PIK3CA (Supplementary Table 2), suggesting that PIK3CA mutations in the helical domain might play a ro

      [Paragraph-level] PMCID: PMC5355930 Section: RESULTS PassageIndex: 9

      Evidence Type(s): Predictive, Prognostic

      Justification: Predictive: The passage suggests that patients with E545K/E542K mutations had shorter progression-free survival (PFS) and overall survival, indicating a potential role of these mutations in resistance to hormone therapy. Prognostic: The mention of shorter PFS and overall survival in patients with the E545K/E542K mutations indicates a correlation with disease outcome independent of therapy.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K

      Genes: 5290

      Variants: E542K E545K

      CIViC paragraph-level PMC5355930 Predictive Prognostic
    10. karim2001khoury 19 Feb 2026
      To examine the role of domain-specific mutations in PIK3CA on everolimus efficacy, patients were categorised by mutation site, H1047R in the catalytic domain, and E545K and E542K in the helical domain. Everolimus prolong

      [Paragraph-level] PMCID: PMC5355930 Section: RESULTS PassageIndex: 8

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses the correlation between PIK3CA mutations (H1047R, E545K, E542K) and the efficacy of everolimus, indicating that these variants are associated with prolonged progression-free survival (PFS) in patients treated with this therapy. Oncogenic: The mention of PIK3CA mutations in the context of their role in tumor development and the efficacy of a cancer treatment suggests that these somatic variants contribute to tumor progression.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K 5290:H1047R

      Genes: 5290

      Variants: E542K E545K H1047R

      CIViC paragraph-level PMC5355930 Predictive Oncogenic
    11. karim2001khoury 19 Feb 2026
      Of the 724 patients in BOLERO-2, 550 patients (76%) underwent PIK3CA cfDNA analysis. The baseline characteristics and clinical outcomes were similar between the cfDNA and overall population (Supplementary Table 1). PIK3C

      [Paragraph-level] PMCID: PMC5355930 Section: RESULTS PassageIndex: 3

      Evidence Type(s): Diagnostic, Predictive

      Justification: Diagnostic: The passage discusses the prevalence of PIK3CA mutations, including specific variants, in a patient population, indicating their association with the disease context. Predictive: The mention of higher prevalence of PIK3CA mutations in the everolimus arm compared to the placebo arm suggests a correlation with treatment response, indicating predictive value.

      Gene→Variant (gene-first): 5290:E542K 5290:E545K 5290:H1047R

      Genes: 5290

      Variants: E542K E545K H1047R

      CIViC paragraph-level PMC5355930 Diagnostic Predictive
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    pmc.ncbi.nlm.nih.gov/articles/PMC5355930/pdf/bjc201725a.pdf