ABSTRACT
Severe oral mucositis (SOM;gr 3–4 on the WHO scale) occurs in about 70% of patients receiving chemoradiotherapy (CRT) for head and neck cancer (HNC). Current treatment approaches focus primarily on symptoms. (Elad 2020) Avasopasem (AVA;GC4419) is an investigational selective dismutase mimetic that rapidly converts superoxide to hydrogen peroxide, potentially interrupting SOM development. (Riley 2007, Sonis 2001) In a phase 2 study, AVA vs placebo reduced SOM duration, incidence, and severity (gr 4 incidence) in patients with locally advanced HNC undergoing CRT (Anderson 2019), prompting initiation of the phase 3 ROMAN study (NCT03689712). The objective of the phase 2 EUSOM open-label trial was to assess the feasibility (safety and efficacy) of a vasospasm in European patients receiving CRT for locally advanced squamous cell carcinoma of the head and neck. In EUSOM (NCT04529850), patients with locally advanced, nonmetastatic HNC in Belgium, Czech Republic, Germany, Poland, Spain and Switzerland received AVA 90 mg IV before each daily fraction (2.0–2.2 Gy, M–F) of intensity-modulated radiation therapy (IMRT;60–72 Gy over appx. 7 weeks), with investigator's choice of cisplatin 100 mg/m2 q3wks x 3 or 40 mg/m2 weekly x 6–7. WHO grade of OM was assessed twice weekly through IMRT then weekly for 4 weeks. The primary endpoint was safety. SOM incidence, severity (gr 4), and duration were secondary endpoints. N=38 enrolled, 37 (median age 61 [range 45–79];81% male) received ≥1 dose of AVA, 33 received ≥ 60 Gy IMRT and ≥ 5 wks AVA (per protocol). Primary tumor: oral (n=15), oropharyngeal (n=20), or other (n=2). AVA median duration of exposure was 6.7 weeks. Median cumulative IMRT dose was 69.3 Gy (range 14–74). Mean cumulative cisplatin dose was 245.5 mg/m2 and 212.3 mg/m2, respectively, for patients receiving q3w (11/37) and weekly (26/37) schedules;91% and 58%, respectively, received ≥200 mg/m2. The most frequent adverse events (AEs) were lymphopenia, nausea, leukopenia, and anemia. Hypotension occurred in 19% (n=7, 3 gr 3) and was the most frequent AVA-related AE (n=5). Serious AEs (N=18;49%) included pneumonia (n=3), COVID-19 (n=2), and hypotension (n=2, 1 AVA-related leading to AVA discontinuation). SOM efficacy for the full and per protocol population (≥60 Gy RT and ≥25 infusion of AVA;n=33) are shown in the table. The AE profile observed in EUSOM was comparable to published data and suggested that vasospasm was well tolerated in these patients. SOM incidence appeared lower than historic expectations. Funder Galera Therapeutics, Inc. [ FROM AUTHOR] Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
ABSTRACT
Introduction. COVID radiotherapy requires performance of all radiotherapy (RT) procedures during one site visit due to the infectious nature of the disease. The aim of the study was to develop methods of estimating the delivered dose based on electronic portal image device (EPID) signal during treatment. Material and methods. Electronic portal image device signal was measured as a function of the phantom dose. The dose in 14 COVID patients was estimated for two X6MV beams. Results. The method allows to estimate dose in phantom with uncertainty of 12%. In this case, a systematic error was reported. Therefore, coefficients for clinical data were calculated and used to determine the dose in patients. The mean difference between the dose calculated and the dose measured for the 14 patients was 1%, but the uncertainty of this method was estimated as ±6% Conclusions. The proposed method may be useful in clinical practice as in vivo method. However, due to high uncertainty, it should be dedicated to the detection of “big” errors.
ABSTRACT
Introduction. The paper presents an original, used in our Institute, method of lung volume irradiation in patients with pneumonia during COVID-19 infection. Material and methods. Procedures such as the simulation of treatment and radiotherapy are performed in a treatment room. Real time radiation treatment planning is realized as 2D planning (Irreg Planning VMS) in a separate room, and the 3D (eclipse VMS) dose distribution is calculated after the treatment. During radiation exposure, a fluence map is measured. Results. A method of irradiating the lungs of patients with COVID-19 was developed, which allows to shorten the time the patient is on the treatment table and minimize contacts between the patient and staff. Conclusions. The presented procedure made it possible to minimize the time of patient's stay in the radiotherapy department and at the same time, it retains all the required quality assurance procedures in radiotherapy treatment.