Frontiers in Oncology (Mar 2023)
Postoperative adjuvant radiochemotherapy with cisplatin versus adjuvant radiochemotherapy with cisplatin and pembrolizumab in locally advanced head and neck squamous cell carcinoma- the study protocol of the Adrisk trial
- Susanne Wiegand,
- Gunnar Wichmann,
- Jeannette Vogt,
- Kathrin Vogel,
- Annegret Franke,
- Thomas Kuhnt,
- Florian Lordick,
- Anne-Marie Scheuble,
- Peter Hambsch,
- Peter Brossart,
- Franz Georg Bauernfeind,
- Holger Kaftan,
- Georg Maschmeyer,
- Matthias Paland,
- Marc Münter,
- Victor Lewitzki,
- Nicole Rotter,
- Carmen Stromberger,
- Carmen Stromberger,
- Marcus Beck,
- Steffen Dommerich,
- Thomas Christoph Gauler,
- Gunnar Hapke,
- Orlando Guntinas-Lichius,
- Ursula Schröder,
- Martin Görner,
- Matthias G. Hautmann,
- Felix Steger,
- Bálint Tamaskovics,
- Anett Schmiedeknecht,
- Andreas Dietz
Affiliations
- Susanne Wiegand
- Department of Otolaryngology, Head and Neck Surgery, Leipzig University Medical Center, Leipzig, Germany
- Gunnar Wichmann
- Department of Otolaryngology, Head and Neck Surgery, Leipzig University Medical Center, Leipzig, Germany
- Jeannette Vogt
- Department of Otolaryngology, Head and Neck Surgery, Leipzig University Medical Center, Leipzig, Germany
- Kathrin Vogel
- Department of Otolaryngology, Head and Neck Surgery, Leipzig University Medical Center, Leipzig, Germany
- Annegret Franke
- Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany
- Thomas Kuhnt
- Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany
- Florian Lordick
- University Cancer Center Leipzig, Leipzig University Medical Center, Leipzig, Germany
- Anne-Marie Scheuble
- University Cancer Center Leipzig, Leipzig University Medical Center, Leipzig, Germany
- Peter Hambsch
- Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany
- Peter Brossart
- Department of Oncology, Hematology, Immuno-Oncology, Rheumatology and Clinical Immunology, University Hospital Bonn, Bonn, Germany
- Franz Georg Bauernfeind
- Department of Oncology, Hematology, Immuno-Oncology, Rheumatology and Clinical Immunology, University Hospital Bonn, Bonn, Germany
- Holger Kaftan
- Department of Otorhinolaryngology, Helios-Klinikum Erfurt, Erfurt, Germany
- Georg Maschmeyer
- Department of Haematology, Oncology, and Palliative Care, Ernst Von Bergmann Clinic, Potsdam, Germany
- Matthias Paland
- Department of Haematology, Oncology, and Palliative Care, Ernst Von Bergmann Clinic, Potsdam, Germany
- Marc Münter
- Institute of Radiotherapy, Klinikum Stuttgart, Stuttgart, Germany
- Victor Lewitzki
- Department of Radiation Oncology, University of Würzburg, Würzburg, Germany
- Nicole Rotter
- 0Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Mannheim, Mannheim, Germany
- Carmen Stromberger
- 1Department of Radiation Oncology, Charité, Berlin, Germany
- Carmen Stromberger
- 2Vivantes Klinikum Neukölln, Department of Radiooncology and Radiotherapy, Berlin, Germany
- Marcus Beck
- 1Department of Radiation Oncology, Charité, Berlin, Germany
- Steffen Dommerich
- 3Department of Otolaryngology, Charité, Berlin, Germany
- Thomas Christoph Gauler
- 4Department of Radiotherapy, West German Cancer Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany
- Gunnar Hapke
- 5Department of Hematology and Oncology, Marienkrankenhaus Hamburg, Hamburg, Germany
- Orlando Guntinas-Lichius
- 6Department of Otorhinolaryngology, Jena University Hospital, Jena, Germany
- Ursula Schröder
- 7Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany
- Martin Görner
- 8Department of Hematology, Oncology and Palliative Medicine, Klinikum Bielefeld Mitte, Bielefeld, Germany
- Matthias G. Hautmann
- 9Department for Radiotherapy, University Hospital Regensburg, Regensburg, Germany
- Felix Steger
- 9Department for Radiotherapy, University Hospital Regensburg, Regensburg, Germany
- Bálint Tamaskovics
- 0Department of Radiation Oncology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany
- Anett Schmiedeknecht
- Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany
- Andreas Dietz
- Department of Otolaryngology, Head and Neck Surgery, Leipzig University Medical Center, Leipzig, Germany
- DOI
- https://doi.org/10.3389/fonc.2023.1128176
- Journal volume & issue
-
Vol. 13
Abstract
Most of the patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. Standards of care for curative-intent treatment of this patient group are either surgery and adjuvant radio(chemo)therapy (aRCT) or definitive chemoradiation. Despite these treatments, especially pathologically intermediate and high-risk HNSCC often recur. The ADRISK trial investigates in locally advanced HNSCC and intermediate and high risk after up-front surgery if the addition of pembrolizumab to aRCT with cisplatin improves event-free sur-vival compared to aRCT alone. ADRISK is a prospective, randomized controlled investiga-tor-initiated (IIT)-phase II multicenter trial within the German Interdisciplinary Study Group of German Cancer Society (IAG-KHT). Patients with primary resectable stage III and IV HNSCC of the oral cavity, oropharynx, hypopharynx and larynx with pathologic high (R1, extracapsular nodal extension) or intermediate risk (R0 <5 mm; N≥2) after surgery will be eligible. Two hun-dred forty patients will be randomly assigned (1:1) to either standard aRCT with cisplatin (standard arm) or aRCT with cisplatin + pembrolizumab (200 mg iv, in 3-week cycle, max. 12 months) (interventional arm). Endpoints are event-free and overall survival. Recruitment started in August 2018 and is ongoing.
Keywords
- head neck cancer
- immunotherapy
- pembrolizumab
- immune checkpoint blockade
- PD-1:PD-L1 axis
- upfront surgery
