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Related Concept Videos

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  5. Biomedical And Clinical Sciences
  7. Oncology And Carcinogenesis
  9. Predictive And Prognostic Markers
  11. Circulating Tumour Dna In Patients With Advanced Melanoma Treated With Dabrafenib Or Dabrafenib Plus Trametinib: A Clinical Validation Study

Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study

Mahrukh M Syeda1, Jennifer M Wiggins1, Broderick C Corless1

  • 1NYU Langone Health, New York, NY, USA.

The Lancet. Oncology
|February 15, 2021

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Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
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Employing Digital Droplet PCR to Detect BRAF V600E Mutations in Formalin-fixed Paraffin-embedded Reference Standard Cell Lines
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View abstract on PubMed

Summary
This summary is machine-generated.

This study shows that cell-free circulating tumor DNA (ctDNA) levels can predict survival in melanoma patients receiving targeted therapy. Monitoring ctDNA changes offers a promising way to track treatment effectiveness.

Area of Science:

  • Oncology
  • Molecular Biology
  • Genetics

Background:

  • Melanoma treatment efficacy lacks validated blood-based biomarkers.
  • Cell-free circulating tumor DNA (ctDNA) shows promise but requires standardized detection and large-scale validation.
  • Serial ctDNA changes and their association with survival outcomes in BRAF/MEK inhibitor therapy are not well-established.

Purpose of the Study:

  • To evaluate if baseline ctDNA concentrations and kinetics can predict survival outcomes in melanoma patients.
  • To assess the utility of ctDNA as a predictive biomarker in patients receiving BRAF, MEK, or BRAF plus MEK inhibitor therapy.
  • To validate droplet digital PCR assays for measuring BRAF V600 mutant ctDNA.

Main Methods:

  • Utilized analytically validated droplet digital PCR assays to measure BRAF V600 mutant ctDNA in plasma samples.

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  • Analyzed pretreatment and on-treatment samples from two clinical trials (COMBI-d and COMBI-MB) involving targeted therapies.
  • Investigated the association between ctDNA levels (baseline, week 4, zero conversion) and efficacy endpoints (PFS, OS, ORR) using Cox models and Kaplan-Meier analysis.

    • Main Results:

    • Elevated baseline ctDNA concentration was significantly associated with worse overall survival (HR 1.13, p<0.0001) in COMBI-d.
    • A ctDNA cutoff of 64 copies/mL stratified patients into high/low risk groups for survival outcomes, validated in COMBI-MB.
    • Undetectable ctDNA at week 4 correlated with extended progression-free and overall survival, especially in patients with elevated LDH.

    Conclusions:

    • Pretreatment and on-treatment BRAF V600 mutant ctDNA measurements can serve as independent, predictive biomarkers of clinical outcome.
    • ctDNA kinetics and baseline levels provide valuable prognostic information for melanoma patients undergoing targeted therapy.
    • This study supports the use of ctDNA monitoring for personalized treatment strategies in melanoma.