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Farlow et al. J Cancer Metastasis Treat 2019;5:18                   Journal of Cancer
               DOI: 10.20517/2394-4722.2018.100                          Metastasis and Treatment




               Review                                                                        Open Access


               Window of opportunity trials in head and neck
               cancer


               Janice L. Farlow , Andrew C. Birkeland , Paul L. Swiecicki , J. Chad Brenner , Matthew E. Spector 1
                                                2
                             1
                                                                 3,4
                                                                                 1
               1 Department of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, MI 48109, USA.
               2 Department of Otolaryngology - Head and Neck Surgery, Stanford University School of Medicine, Palo Alto, CA 94303, USA.
               3 Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan, Ann Arbor, MI 48109, USA.
               4 Department of Internal Medicine, Division of Hematology and Oncology, Ann Arbor Veterans Medical Center, Ann Arbor, MI
               48105, USA.

               Correspondence to: Dr. Matthew Spector, Department of Otolaryngology - Head and Neck Surgery, University of Michigan,
               1500 E. Medical Center Dr., Ann Arbor, MI 48109, USA. E-mail: mspector@med.umich.edu

               How to cite this article: Farlow JL, Birkeland AC, Swiecicki PL, Brenner JC, Spector ME. Window of opportunity trials in head and
               neck cancer. J Cancer Metastasis Treat 2019;5:18. http://dx.doi.org/10.20517/2394-4722.2018.100

               Received: 14 Dec 2018    First Decision: 7 Jan 2019     Revised: 14 Jan 2019    Accepted: 22 Jan 2019    Published: 18 Mar 2019

               Science Editor: Bingliang Fang    Copy Editor: Cai-Hong Wang    Production Editor: Huan-Liang Wu



               Abstract
               Head and neck squamous cell carcinoma (HNSCC) has a large global burden of disease and poor survival
               outcomes. Recent targeted therapies and immunotherapies have been explored in HNSCC, but there has been
               limited translation to clinical practice outside of recurrent or metastatic cases. Window of opportunity settings,
               where novel agents are administered between cancer diagnosis and planned definitive therapy, have begun to be
               employed in HNSCC. Tumor tissue biopsies are obtained at diagnosis and after the investigation treatment, along
               with other biospecimens and radiographic exams. Thus, this study design can characterize the safety profiles,
               pharmacodynamics, and initial tumor responses to novel therapies in a treatment-naïve subject. Early window
               studies have also identified potential biomarkers to predict sensitivity or resistance to treatments. However,
               these early investigations have revealed multiple challenges associated with this trial design. In this review, we
               discuss recent window of opportunity trials in HNSCC and how they inform design considerations for future
               studies.

               Keywords: Window of opportunity trial, head and neck cancer, biomarker, translational research, preoperative,
               oncology, trials






                           © The Author(s) 2019. Open Access This article is licensed under a Creative Commons Attribution 4.0
                           International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use,
                sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long
                as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license,
                and indicate if changes were made.


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