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.

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.

Maintaining an Adult Hematology/Oncology Service at a Tertiary Care Center during the SARS-CoV-2 Pandemic: An Eight-Week-Experience with a Newly Implemented Procedural Plan.

Treatment of cancer patients has become challenging when large parts of hospital services need to be shut down as a consequence of a local COVID-19 outbreak that requires rapid containment measures, in conjunction with the shifting of priorities to vital services. Reports providing conceptual frameworks and first experiences on how to maintain a clinical hematology/oncology service during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic are scarce. Here, we report our first 8 weeks of experience after implementing a procedural plan at a hematology/oncology unit with its associated cancer center at a large academic teaching hospital in Germany. By strictly separating team workflows and implementing vigorous testing for SARS-CoV-2 infections for all patients and staff members irrespective of clinical symptoms, we were successful in maintaining a comprehensive hematology/oncology service to allow for the continuation of treatment for our patients. Notably, this was achieved without introducing or further transmitting SARS-CoV-2 infections within the unit and the entire center. Although challenging, our approach appears safe and feasible and may help others to set up or optimize their procedures for cancer treatment or for other exceedingly vulnerable patient cohorts.