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Phase I Study Methodology in Head and Neck Oncology

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Head and Neck Cancer

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Abstract

Phase I trials evaluating anticancer treatments in locoregionally advanced or recurrent metastatic head and neck squamous cell carcinomas (HNSCC) require disease-specific considerations. In the locoregionally advanced setting, trials are often conducted in combination with radiation (RT) in patients with a curative diagnosis. Both safety and efficacy are relevant factors in their design and conduct. Preclinical evidence of safety, as well as appropriate biological justification of antitumor activity, should be available to rationalize the incorporation of new agents in the combination treatment regime. Trials enrolling patients with recurrent and/or metastatic HNSCC have been transformed by the advent of molecularly targeted agents and immune checkpoint inhibitors. Several challenges are faced by these studies which include patient enrichment, measurement of efficacy, and determining the optimal biological dose. Regardless of the disease stage, innovative clinical trial designs; identification of predictive, therapeutic, and toxicity biomarkers; and detection of early signals of antitumor activity are urgently needed to expedite the development of safe and effective combination regimes in HNSCC.

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Authors and Affiliations

  1. Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada

    Aaron Hansen BSc, MBBS

  2. Department of Medical Oncology, Institut Curie, 26 rue d’ulm, Paris, 75005, France

    Christophe Le Tourneau MD, PhD

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  1. Aaron Hansen BSc, MBBS
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  2. Christophe Le Tourneau MD, PhD
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Correspondence to Christophe Le Tourneau MD, PhD .

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Editors and Affiliations

  1. Department of Radio-Oncology, Genolier Swiss Medical Network, Genolier, Switzerland

    Jacques Bernier

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Hansen, A., Le Tourneau, C. (2016). Phase I Study Methodology in Head and Neck Oncology. In: Bernier, J. (eds) Head and Neck Cancer. Springer, Cham. https://doi.org/10.1007/978-3-319-27601-4_43

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  • DOI: https://doi.org/10.1007/978-3-319-27601-4_43

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