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    1. Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study

      [Paper-level Aggregated] PMCID: PMC9338780

      Evidence Type(s): Predictive, Oncogenic, Prognostic

      Justification: Predictive: The text discusses the approval of dabrafenib plus trametinib for treatment of BRAF V600E-mutant anaplastic thyroid cancer, indicating that the presence of the V600E mutation predicts a positive response to this therapy. Oncogenic: The BRAF V600E mutation is implicated in the pathogenesis of anaplastic thyroid cancer, suggesting its role as an oncogenic driver in this disease. Prognostic: The updated results indicate that patients with BRAF V600E-mutant ATC experienced improved long-term survival with the treatment, suggesting that the mutation may serve as a prognostic marker for treatment outcomes.

      Gene→Variant (gene-first): BRAF(673):V600E

      Genes: BRAF(673)

      Variants: V600E

    2. Investigator-assessed confirmed responses were reported in 20 of 36 patients (56%) in the ITT-assessable population, including 3 CRs (8%) and 17 PRs (47%; Table 3, Figure 1); an additional 11 patients (31%) had stable di

      [Paragraph-level] PMCID: PMC9338780 Section: RESULTS PassageIndex: 4

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage discusses the correlation between the BRAF V600E mutation and the response to treatment, indicating that all patients with confirmed responses had BRAF V600E-mutant disease, which suggests a predictive relationship with therapy response. Diagnostic: The mention of "centrally confirmed BRAF V600E-mutant disease" indicates that the variant is used to classify or confirm a specific disease subtype, supporting its role as a diagnostic marker.

      Gene→Variant (gene-first): 673:V600E

      Genes: 673

      Variants: V600E

    3. The ATC cohort totaled 36 patients in the ITT-assessable population, including 15 from the primary analysis cohort and 21 from the expansion cohort (Supplementary Figure S1, available at https://doi.org/10.1016/j.annonc.

      [Paragraph-level] PMCID: PMC9338780 Section: RESULTS PassageIndex: 2

      Evidence Type(s): Diagnostic, Oncogenic

      Justification: Diagnostic: The passage states that 33 out of 36 patients had the BRAF V600E mutation confirmed, indicating its use in defining or confirming a disease subtype, specifically in the context of ATC (anaplastic thyroid carcinoma). Oncogenic: The BRAF V600E mutation is known to contribute to tumor development or progression, which aligns with the evidence type of oncogenic variants in cancer.

      Gene→Variant (gene-first): 673:V600E

      Genes: 673

      Variants: V600E

    4. These updated results confirm the substantial clinical benefit and manageable toxicity of dabrafenib plus trametinib in BRAF V600E-mutant ATC. Dabrafenib plus trametinib notably improved long-term survival and represents

      [Paragraph-level] PMCID: PMC9338780 Section: ABSTRACT PassageIndex: 8

      Evidence Type(s): Predictive, Prognostic

      Justification: Predictive: The passage discusses the clinical benefit of dabrafenib plus trametinib in BRAF V600E-mutant ATC, indicating a correlation with improved treatment response. Prognostic: The mention of improved long-term survival in patients with BRAF V600E-mutant ATC suggests a correlation with disease outcome independent of therapy.

      Gene→Variant (gene-first): 673:V600E

      Genes: 673

      Variants: V600E

    5. ROAR (NCT02034110) is an open-label, nonrandomized, phase II basket study evaluating dabrafenib plus trametinib in BRAF V600E-mutant rare cancers. The ATC cohort comprised 36 patients with unresectable or metastatic ATC

      [Paragraph-level] PMCID: PMC9338780 Section: ABSTRACT PassageIndex: 4

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses the evaluation of dabrafenib plus trametinib in patients with BRAF V600E-mutant cancers, indicating a correlation with treatment response. Oncogenic: The mention of BRAF V600E in the context of a study for rare cancers suggests that this somatic variant contributes to tumor development or progression.

      Gene→Variant (gene-first): 673:V600E

      Genes: 673

      Variants: V600E

    6. Combined therapy with dabrafenib plus trametinib was approved in several countries for treatment of BRAF V600E-mutant anaplastic thyroid cancer (ATC) based on an earlier interim analysis of 23 response-assessable patient

      [Paragraph-level] PMCID: PMC9338780 Section: ABSTRACT PassageIndex: 2

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage discusses the approval of combined therapy with dabrafenib plus trametinib for treatment of BRAF V600E-mutant anaplastic thyroid cancer, indicating a correlation with treatment response. Diagnostic: The mention of BRAF V600E as a specific mutation in anaplastic thyroid cancer suggests its role in defining or classifying the disease subtype.

      Gene→Variant (gene-first): 673:V600E

      Genes: 673

      Variants: V600E

    7. These updated results confirm the substantial clinical benefit and manageable toxicity of dabrafenib plus trametinib in BRAF V600E-mutant ATC. Dabrafenib plus trametinib notably improved long-term survival and represents

      [Paragraph-level] PMCID: PMC9338780 Section: ABSTRACT PassageIndex: 8

      Evidence Type(s): Predictive, Prognostic

      Justification: Predictive: The passage discusses the clinical benefit of dabrafenib plus trametinib in BRAF V600E-mutant ATC, indicating a correlation with improved treatment response. Prognostic: The mention of improved long-term survival in patients with BRAF V600E-mutant ATC suggests a correlation with disease outcome independent of therapy.

      Gene→Variant (gene-first): 673:V600E

      Genes: 673

      Variants: V600E

    8. ROAR (NCT02034110) is an open-label, nonrandomized, phase II basket study evaluating dabrafenib plus trametinib in BRAF V600E-mutant rare cancers. The ATC cohort comprised 36 patients with unresectable or metastatic ATC

      [Paragraph-level] PMCID: PMC9338780 Section: ABSTRACT PassageIndex: 4

      Evidence Type(s): Predictive, Oncogenic

      Justification: Predictive: The passage discusses the evaluation of dabrafenib plus trametinib in patients with BRAF V600E-mutant cancers, indicating a correlation with treatment response. Oncogenic: The mention of BRAF V600E in the context of a study for rare cancers suggests that this somatic variant contributes to tumor development or progression.

      Gene→Variant (gene-first): 673:V600E

      Genes: 673

      Variants: V600E

    9. Combined therapy with dabrafenib plus trametinib was approved in several countries for treatment of BRAF V600E-mutant anaplastic thyroid cancer (ATC) based on an earlier interim analysis of 23 response-assessable patient

      [Paragraph-level] PMCID: PMC9338780 Section: ABSTRACT PassageIndex: 2

      Evidence Type(s): Predictive, Diagnostic

      Justification: Predictive: The passage discusses the approval of combined therapy with dabrafenib plus trametinib for treatment of BRAF V600E-mutant anaplastic thyroid cancer, indicating a correlation with treatment response. Diagnostic: The mention of BRAF V600E as a specific mutation in anaplastic thyroid cancer suggests its role in defining or classifying the disease subtype.

      Gene→Variant (gene-first): 673:V600E

      Genes: 673

      Variants: V600E