Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II-III trial.

BACKGROUND: Platinum-based chemoradiation (CCRT) is the standard treatment for Locally Advanced Head and Neck Squamous-Cell Carcinoma (LAHNSCC). Cetuximab/RT (CET/RT) is an alternative treatment option to CCRT. The efficacy of induction chemotherapy (IC) followed by chemoradiation compared to chemoradiation alone has not been demonstrated in randomized clinical trials. The goals of this phase II-III trial were to assess: (i) the overall survival (OS) of IC versus no-induction (no-IC) and (ii) the Grade 3-4 in-field mucosal toxicity of CCRT versus CET/RT. The present paper focuses on the analysis of efficacy. MATERIALS AND METHODS: Patients with LAHNSCC were randomized to receive concomitant treatment alone [CCRT (Arm A1) or CET/RT (Arm A2)], or three cycles of induction docetaxel/cisplatin/5 fluorouracil (TPF) followed by CCRT (Arm B1) or followed by CET/RT (Arm B2). The superiority hypothesis of OS comparison of IC versus no-IC (Arms B1 + B2 versus A1 + A2) required 204 deaths to detect an absolute 3-year OS difference of 12% (HR 0.675, with 80% power at two-sided 5% significance level). RESULTS: 414 out of 421 patients were finally analyzed: 206 in the IC and 208 in the no-IC arm. Six patients were excluded because of major violation and one because of metastatic disease at diagnosis. With a median follow-up of 44.8 months, OS was significantly higher in the IC arm (HR 0.74; 95% CI 0.56-0.97; P = 0.031). Complete Responses (P = 0.0028), Progression Free Survival (P = 0.013) and the Loco-regional Control (P = 0.036) were also significantly higher in the IC arm. Compliance to concomitant treatments was not affected by induction TPF. CONCLUSIONS: IC followed by concomitant treatment improved the outcome of patients with LAHNSCC without compromising compliance to the concomitant treatments. The degree of the benefit of IC could be different according to the type of the subsequent concomitant strategy. CLINICAL TRIAL NUMBER: NCT01086826, www.clinicaltrials.gov.

The efficacy of ultraviolet light-emitting technology against coronaviruses: a systematic review.

The ongoing pandemic of COVID-19 has underlined the importance of adopting effective infection prevention and control (IPC) measures in hospital and community settings. Ultraviolet (UV)-based technologies represent promising IPC tools: their effective application for sanitation has been extensively evaluated in the past but scant, heterogeneous and inconclusive evidence is available on their effect on SARS-CoV-2 transmission. With the aim of pooling the available evidence on the efficacy of UV technologies against coronaviruses, we conducted a systematic review following PRISMA guidelines, searching Medline, Embase and the Cochrane Library, and the main clinical trials' registries (WHO ICTRP, ClinicalTrials.gov, Cochrane and EU Clinical Trial Register). Quantitative data on studies' interventions were summarized in tables, pooled by different coronavirus species and strain, UV source, characteristics of UV light exposure and outcomes. Eighteen papers met our inclusion criteria, published between 1972 and 2020. Six focused on SARS-CoV-2, four on SARS-CoV-1, one on MERS-CoV, three on seasonal coronaviruses, and four on animal coronaviruses. All were experimental studies. Overall, despite wide heterogenicity within included studies, complete inactivation of coronaviruses on surfaces or aerosolized, including SARS-CoV-2, was reported to take a maximum exposure time of 15 min and to need a maximum distance from the UV emitter of up to 1 m. Advances in UV-based technologies in the field of sanitation and their proved high virucidal potential against SARS-CoV-2 support their use for IPC in hospital and community settings and their contribution towards ending the COVID-19 pandemic. National and international guidelines are to be updated and parameters and conditions of use need to be identified to ensure both efficacy and safety of UV technology application for effective infection prevention and control in both healthcare and non-healthcare settings.