TY - JOUR
T1 - 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
AU - Wiegand, Susanne
AU - Wichmann, Gunnar
AU - Vogt, Jeannette
AU - Vogel, Kathrin
AU - Franke, Annegret
AU - Kuhnt, Thomas
AU - Lordick, Florian
AU - Scheuble, Anne Marie
AU - Hambsch, Peter
AU - Brossart, Peter
AU - Bauernfeind, Franz Georg
AU - Kaftan, Holger
AU - Maschmeyer, Georg
AU - Paland, Matthias
AU - Münter, Marc
AU - Lewitzki, Victor
AU - Rotter, Nicole
AU - Stromberger, Carmen
AU - Beck, Marcus
AU - Dommerich, Steffen
AU - Gauler, Thomas Christoph
AU - Hapke, Gunnar
AU - Guntinas-Lichius, Orlando
AU - Schröder, Ursula
AU - Görner, Martin
AU - Hautmann, Matthias G.
AU - Steger, Felix
AU - Tamaskovics, Bálint
AU - Schmiedeknecht, Anett
AU - Dietz, Andreas
N1 - Publisher Copyright:
Copyright © 2023 Wiegand, Wichmann, Vogt, Vogel, Franke, Kuhnt, Lordick, Scheuble, Hambsch, Brossart, Bauernfeind, Kaftan, Maschmeyer, Paland, Münter, Lewitzki, Rotter, Stromberger, Beck, Dommerich, Gauler, Hapke, Guntinas-Lichius, Schröder, Görner, Hautmann, Steger, Tamaskovics, Schmiedeknecht and Dietz.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - PD-1:PD-L1 axis
KW - head neck cancer
KW - immune checkpoint blockade
KW - immunotherapy
KW - locoregional disease
KW - pembrolizumab
KW - randomized controlled phase IIB clinical trial
KW - upfront surgery
UR - http://www.scopus.com/inward/record.url?scp=85151417673&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85151417673&partnerID=8YFLogxK
U2 - 10.3389/fonc.2023.1128176
DO - 10.3389/fonc.2023.1128176
M3 - Article
AN - SCOPUS:85151417673
SN - 2234-943X
VL - 13
JO - Frontiers in Oncology
JF - Frontiers in Oncology
M1 - 1128176
ER -