Clinical Trial Development in TP53-Mutated Locally Advanced and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Author:

Rodriguez Cristina P1ORCID,Kang Hyunseok2,Geiger Jessica L3,Burtness Barbara4,Chung Christine H5,Pickering Curtis R6,Fakhry Carole7,Le Quynh Thu8,Yom Sue S9,Galloway Thomas J10,Golemis Erica9,Li Alice11,Shoop Jeffrey,Wong Stuart12,Mehra Ranee13,Skinner Heath14,Saba Nabil F15ORCID,Flores Elsa R16,Myers Jeffrey N6,Ford James M17,Karchin Rachel18ORCID,Ferris Robert L19ORCID,Kunos Charles20,Lynn Jean M20,Malik Shakun20ORCID

Affiliation:

1. Department of Medicine, University of Washington , Seattle, WA, USA

2. Department of Medicine, University of California San Francisco , San Francisco, CA, USA

3. Department of Hematology and Medical Oncology, Cleveland Clinic Foundation , Cleveland, OH, USA

4. Department of Medicine, Yale University , New Haven, CT, USA

5. Department of Head and Neck-Endocrine Oncology, Moffit Cancer Center , Tampa, FL, USA

6. Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center , Houston, TX, USA

7. Division of Head and Neck Surgery, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University , Baltimore, MD, USA

8. Department of Radiation Oncology-Radiation Therapy, Stanford University , Palo Alto, CA, USA

9. Department of Radiation Oncology, University of California San Francisco , San Francisco, CA, USA

10. Department of Radiation Oncology, Fox Chase Cancer Center , Philadelphia, PA, USA

11. Kaiser Permanente Oakland , Oakland, CA, USA

12. Division of Neoplastic Diseases, Department of Medicine, Medical College of Wisconsin , Milwaukee, WI, USA

13. Division of Hematology/Oncology, Department of Medicine, University of Maryland , Baltimore, MD, USA

14. Department of Radiation Oncology, University of Pittsburgh , Pittsburgh, PA, USA

15. Department of Hematology and Medical Oncology, Emory University , Atlanta, GA, USA

16. Department of Molecular Oncology, Moffit Cancer Center , Tampa, FL, USA

17. Department of Medicine, Stanford University , Palo Alto, CA, USA

18. Department of Oncology, Johns Hopkins University , Baltimore, MD, USA

19. Department of Otolaryngology, University of Pittsburgh , Pittsburgh, PA, USA

20. National Institutes of Health , Bethesda, MD, USA

Abstract

Abstract TP53 mutation is the most frequent genetic event in head and neck squamous cell carcinoma (HNSCC), found in more than 80% of patients with human papillomavirus–negative disease. As mutations in the TP53 gene are associated with worse outcomes in HNSCC, novel therapeutic approaches are needed for patients with TP53-mutated tumors. The National Cancer Institute sponsored a Clinical Trials Planning Meeting to address the issues of identifying and developing clinical trials for patients with TP53 mutations. Subcommittees, or breakout groups, were tasked with developing clinical studies in both the locally advanced and recurrent and/or metastatic (R/M) disease settings as well as considering signal-seeking trial designs. A fourth breakout group was focused on identifying and standardizing biomarker integration into trial design; this information was provided to the other breakout groups prior to the meeting to aid in study development. A total of 4 concepts were prioritized to move forward for further development and implementation. This article summarizes the proceedings of the Clinical Trials Planning Meeting with the goal of developing clinical trials for patients with TP53-mutant HNSCC that can be conducted within the National Clinical Trials Network.

Funder

NCI Coordinating Center for Clinical Trials

NCI Head & Neck Cancer Steering Committee

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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