Low-dose Radiation Therapy in the Management of COVID-19 Pneumonia (LOWRAD-Cov19). Final results of a prospective phase I–II trial

Sanmamed, Noelia; Alcántara Carrió, María Del Pino; Bustos García De Castro, Ana María; Corona Sánchez, Juan Antonio; Gaztañaga Boronat, Miren; Cabello Clotet, Noemí; Ortuño Andériz, Francisco; Castro Fernández, Javier De; Fuentes Ramos, Manuel; Vazquez, Manuel

Low-dose Radiation Therapy in the Management of COVID-19 Pneumonia (LOWRAD-Cov19). Final results of a prospective phase I–II trial

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Low-dose Radiation Therapy in the Management of COVID-19 Pneumonia (LOWRAD-Cov19). Final results of a prospective phase I–II trial 2022.pdf (345.26 KB)

Official URL

http://dx.doi.org/10.1016/j.radonc.2022.03.015

Publication date

2022

Editors

Michael Baumann, MD

Publisher

Elsevier

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URI

https://hdl.handle.net/20.500.14352/100338

Citation

Sanmamed N, Alcantara P, Gómez S, Bustos A, Cerezo E, Gaztañaga M, Doval A, Corona J, Rodriguez G, Cabello N, Duffort M, Ortuño F, de Castro J, López A, Fuentes M, Sanz A, Vazquez M. Low-dose Radiation Therapy in the Management of COVID-19 Pneumonia (LOWRAD-Cov19). Final results of a prospective phase I-II trial. Radiother Oncol. 2022 Jun;171:25-29. doi: 10.1016/j.radonc.2022.03.015. Epub 2022 Mar 31. PMID: 35367528; PMCID: PMC8968128.

Abstract

Background and purpose: To evaluate the results of low-dose radiation therapy (LD-RT) to lungs in the management of patients with COVID-19 pneumonia. Material and methods: We conducted a prospective phase I-II trial enrolling COVID-19 patients ≥50 years-old, with bilateral lung involvement at imaging study and oxygen requirement (oxygen saturation ≤93% on room air). Patients received 1 Gy to whole lungs in a single fraction. Primary outcome was a radiological response assessed as severity and extension scores at days +3 and +7. Secondary outcomes were toxicity (CTCAE v5.0), days of hospitalization, changes in inflammatory blood parameters (ferritin, lymphocytes, C-reactive protein, d-dimer and LDH) and SatO2/FiO2 index (SAFI), at day +3 and +7. Descriptive analyses were summarized as means with standard deviation (SD) and/or medians with interquartile ranges (IQR). A Wilcoxon sign rank test for paired data was used to assess the CT scores and Chi Square was used to assess for comparison of categorical variables. Results: Forty-one patients were included. Median age was 71 (IQR 60-84). Eighteen patients (44%) previously received an anti-COVID treatment (tocilizumab, lopinavir/ritonavir, remdesivir) and thirty-two patients (84%) received steroids during LD-RT. The extension score improved significantly (p = 0.02) on day +7. Mean baseline extension score was 13.7 (SD ± 4.9) with a score of 12.2 (±5.2) at day 3, and 12.4 ± 4.7 at day 7. No differences were found in the severity score. SAFI improved significantly on day +3 and +7 (p < 0.01). Median SAFI on day 0 was 147 (IQR 118-264), 230 (IQR 120-343) on day +3 and 293 (IQR 121-353) on day +7. Significant decrease was found in C-reactive protein on day +7 (p = 0.02) and in lymphocytes counts on day +3 and +7 (p = 0.02). The median number of days in hospital after RT was 11 (range 4-78). With a median follow-up of 60 days after LD-RT, 26 (63%) patients were discharged, 11 (27%) died because of COVID respiratory failure and 4 (10%) died of other causes. Conclusions: LD-RT is a feasible and well-tolerated treatment that could lead to rapid clinical improvement. Large randomized trials would be required to establish the efficacy of LD-RT to treat COVID-19 pneumonia.

Description

Highlights • LD-RT is feasible and well tolerated treatment for patients diagnosed with COVID-19. One week after LD-RT, 42% of the patients experienced a radiological response. • Thirty-nine percent of the patients experienced a rapid respiratory improvement (<72 h). • One week after LD-RT, 42% of the patients experienced a radiological response. • Patients were discharged a median of 11 days after LD-RT.