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The evolving paradigm of biomarker actionability: Histology-agnosticism as a spectrum, rather than a binary quality
Paolo Tarantino1, Luca Mazzarella2, Antonio Marra1
1European Institute of Oncology IRCCS, Milan, Italy; University of Milan, Milan, Italy.
Abstract:
Precision medicine is progressively revolutionizing oncology, through the identification of biomarkers predictive of treatment response in cancer patients. For three of such biomarkers, namely NTRK-fusions, microsatellite instability and high tumor mutational burden, drugs have been approved by regulatory agencies regardless of tumor histology, realizing the paradigm of histology-agnostic actionability. Several additional biomarkers are being studied in a histology-agnostic manner, and may in the future expand this list. However, most available evidence suggest that histology-agnosticism may be the extreme of a continuous spectrum of actionability, rather than a binary quality. The present review recapitulates such evidence, highlighting opportunities and challenges posed by the emergence of the spectrum of biomarker actionability in the context of a prevalently histology-based oncology.
Insights
Precision medicine is transforming cancer care by identifying biomarkers for treatment. While some biomarkers are histology-agnostic, actionability exists on a spectrum, not just binary.
Area of Science:
- Oncology
- Genomics
- Precision Medicine
Background:
- Precision medicine utilizes biomarkers to predict cancer treatment response.
- Approved therapies targeting NTRK-fusions, microsatellite instability, and high tumor mutational burden demonstrate histology-agnostic actionability.
- The concept of histology-agnosticism is expanding with ongoing research into additional biomarkers.
Purpose of the Study:
- To review evidence on the spectrum of biomarker actionability in oncology.
- To highlight the opportunities and challenges of biomarker actionability beyond histology-based approaches.
Main Methods:
- Literature review of precision medicine in oncology.
- Analysis of evidence supporting histology-agnostic and histology-dependent biomarker actionability.
- Discussion of the implications for current oncology practices.
Main Results:
- Histology-agnosticism represents an extreme of a continuous spectrum of biomarker actionability.
- Most biomarkers exhibit varying degrees of actionability, not a simple binary classification.
- The shift towards biomarker-driven oncology presents both advancements and complexities.
Conclusions:
- Biomarker actionability in oncology is best understood as a spectrum rather than a binary concept.
- The emergence of histology-agnostic therapies broadens treatment options but requires nuanced application.
- Future oncology practice will increasingly integrate biomarker data, moving beyond traditional histology-based classifications.
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