ABSTRACT
BACKGROUND: Solid cancer is an independent prognostic factor for poor outcome with COVID-19. As guidelines for patient management in that setting depend on retrospective efforts, we here present the first analyses of a nationwide database of patients with cancer hospitalized with COVID-19 in Belgium, with a focus on changes in anticancer treatment plans at the time of SARS-CoV-2 infection. METHODS: Nineteen Belgian hospitals identified all patients with a history of solid cancer hospitalized with COVID-19 between March 2020 and February 2021. Demographic, cancer-specific and COVID-specific data were pseudonymously entered into a central Belgian Society of Medical Oncology (BSMO)-COVID database. The association between survival and primary cancer type was analyzed through multivariate multinomial logistic regression. Group comparisons for categorical variables were carried out through a Chi-square test. RESULTS: A total of 928 patients were registered in the database; most of them were aged ≥70 years (61.0%) and with poor performance scores [57.2% Eastern Cooperative Oncology Group (ECOG) ≥2]. Thirty-day COVID-related mortality was 19.8%. In multivariate analysis, a trend was seen for higher mortality in patients with lung cancer (27.6% versus 20.8%, P = 0.062) and lower mortality for patients with breast cancer (13.0% versus 23.3%, P = 0.052) compared with other tumour types. Non-curative treatment was associated with higher 30-day COVID-related mortality rates compared with curative or no active treatment (25.8% versus 14.3% versus 21.9%, respectively, P < 0.001). In 33% of patients under active treatment, the therapeutic plan was changed due to COVID-19 diagnosis, most frequently involving delays/interruptions in systemic treatments (18.6%). Thirty-day COVID-related mortality was not significantly different between patients with and without treatment modifications (21.4% versus 20.5%). CONCLUSION: Interruption in anticancer treatments at the time of SARS-CoV-2 infection was not associated with a reduction in COVID-related mortality in our cohort of patients with solid cancer, highlighting that treatment continuation should be strived for, especially in the curative setting.
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.)