Personalized biomarker-based treatment strategy for patients with squamous cell carcinoma of the head and neck: EORTC position and approach
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Updated: Feb 4, 2026

A Model for Perineural Invasion in Head and Neck Squamous Cell Carcinoma
Published on: January 5, 2017
R Galot1, C Le Tourneau2, J Guigay3
1Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc, Belgium; Institute for Clinical and Experimental Research (POLE MIRO), Université Catholique de Louvain, Brussels, Belgium.
Abstract:
The molecular landscape of squamous cell carcinoma of the head and the neck (SCCHN) has been characterized and actionable or targetable genomic alterations have been identified. However, targeted therapies have very limited activity in unselected SCCHN, and the current treatment strategy is still based on tumor location and disease stage and not on tumor biology. Trying to select upfront the patients who will benefit from a specific treatment might be a way to improve patients' outcome. With the objective of optimizing the activity of targeted therapies and immunotherapy, we have designed an umbrella biomarker-driven study dedicated to recurrent and/or metastatic SCCHN patients (EORTC-1559-HNCG, NCT03088059). In this article, we review not only the different trial designs for biomarker-driven studies with their respective advantages and opportunities but also the potential pitfalls that led to the design of the EORTC-1559-HNCG protocol. We also discuss the scientific and logistic challenges of biomarker-driven trials.
Insights
Biomarker-driven studies can improve outcomes for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) by matching patients to targeted therapies and immunotherapy based on tumor biology, overcoming limitations of current treatment strategies.
Area of Science:
- Oncology
- Genomics
- Clinical Trial Design
Background:
- Squamous cell carcinoma of the head and neck (SCCHN) has identified genomic alterations, but targeted therapies show limited efficacy in unselected patients.
- Current SCCHN treatment relies on tumor location and stage, not molecular characteristics, hindering optimal patient outcomes.
Purpose of the Study:
- To optimize targeted therapy and immunotherapy effectiveness in recurrent/metastatic SCCHN.
- To design and discuss a biomarker-driven umbrella study (EORTC-1559-HNCG) for SCCHN patients.
- To review trial designs, advantages, pitfalls, and challenges in biomarker-driven oncology research.
Main Methods:
- Design of an umbrella biomarker-driven study (EORTC-1559-HNCG, NCT03088059) for recurrent/metastatic SCCHN.
- Review of various biomarker-driven trial designs, their benefits, and potential drawbacks.
- Discussion of scientific and logistical challenges inherent in biomarker-driven clinical trials.
Main Results:
- Identification of actionable genomic alterations in SCCHN.
- Limited efficacy of current targeted therapies in unselected SCCHN populations.
- Need for patient stratification based on tumor biology to improve treatment response.
Conclusions:
- Biomarker-driven approaches are crucial for advancing SCCHN treatment efficacy.
- The EORTC-1559-HNCG protocol exemplifies a strategy to personalize SCCHN therapy.
- Careful consideration of trial design and logistical factors is essential for successful biomarker-driven studies in SCCHN.
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