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

R Galot; C Le Tourneau; J Guigay; L Licitra; I Tinhofer; A Kong; C Caballero; C Fortpied; J Bogaerts; A-S Govaerts; D Staelens; T Raveloarivahy; L Rodegher; J-F Laes; E Saada-Bouzid; J-P Machiels

doi:10.1093/annonc/mdy452

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

Ann Oncol. 2018 Dec 1;29(12):2313-2327. doi: 10.1093/annonc/mdy452.

Authors

R Galot¹, C Le Tourneau², J Guigay³, L Licitra⁴, I Tinhofer⁵, A Kong⁶, C Caballero⁷, C Fortpied⁷, J Bogaerts⁷, A-S Govaerts⁷, D Staelens⁷, T Raveloarivahy⁷, L Rodegher⁷, J-F Laes⁸, E Saada-Bouzid³, J-P Machiels⁹

Affiliations

¹ Department 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.
² Department of Drug Development and Innovation, Institut Curie, Paris & Saint-Cloud, Paris, France; INSERM U900 Research Unit, Saint-Cloud, France; Versailles-Saint-Quentin-en-Yvelines University, Montigny-le-Bretonneux, France.
³ Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
⁴ Head and Neck Cancer Medical Oncology Department, Fondazione IRCCS "Istituto Nazionale dei Tumori", Milan; Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.
⁵ Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin; Department of Radiooncology and Radiotherapy, Berlin Institute of Health, Berlin, Germany.
⁶ Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
⁷ European Organization of Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
⁸ OncoDNA, Gosselies, Belgium.
⁹ Department 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. Electronic address: [email protected].

PMID: 30307465
DOI: 10.1093/annonc/mdy452

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.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Antineoplastic Agents / pharmacology
Antineoplastic Agents / therapeutic use*
Biomarkers, Tumor / antagonists & inhibitors
Biomarkers, Tumor / genetics*
Biomarkers, Tumor / metabolism
Biopsy
Clinical Trials as Topic
Disease-Free Survival
Europe
Head and Neck Neoplasms / drug therapy*
Head and Neck Neoplasms / genetics
Head and Neck Neoplasms / mortality
Head and Neck Neoplasms / pathology
Humans
Molecular Targeted Therapy / methods
Neoplasm Recurrence, Local / drug therapy*
Neoplasm Recurrence, Local / genetics
Neoplasm Recurrence, Local / mortality
Neoplasm Recurrence, Local / pathology
Patient Selection
Precision Medicine / methods
Progression-Free Survival
Research Design
Squamous Cell Carcinoma of Head and Neck / drug therapy*
Squamous Cell Carcinoma of Head and Neck / genetics
Squamous Cell Carcinoma of Head and Neck / mortality
Squamous Cell Carcinoma of Head and Neck / pathology

Substances

Antineoplastic Agents
Biomarkers, Tumor

Associated data

ClinicalTrials.gov/NCT03088059