Author:
Wiegand Susanne,Wichmann Gunnar,Vogt Jeannette,Vogel Kathrin,Franke Annegret,Kuhnt Thomas,Lordick Florian,Scheuble Anne-Marie,Hambsch Peter,Brossart Peter,Bauernfeind Franz Georg,Kaftan Holger,Maschmeyer Georg,Paland Matthias,Münter Marc,Lewitzki Victor,Rotter Nicole,Stromberger Carmen,Beck Marcus,Dommerich Steffen,Gauler Thomas Christoph,Hapke Gunnar,Guntinas-Lichius Orlando,Schröder Ursula,Görner Martin,Hautmann Matthias G.,Steger Felix,Tamaskovics Bálint,Schmiedeknecht Anett,Dietz Andreas
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.