High-dose dexamethasone should not be used to treat dyspnea in patients with cancer, according to the results of a randomized clinical trial. These study findings were recently reported in The Lancet Oncology.
Patients with cancer commonly face dyspnea, and evidence suggests that inflammation is involved with the development of this symptom. It is often treated with corticosteroids, which can also cause adverse events, and the research supporting the use of corticosteroid treatment for dyspnea with cancer has been limited. For these reasons, researchers conducted this study to evaluate high-dose dexamethasone, compared with placebo, in treating dyspnea with cancer.
The study was the double-blind ABCD trial (Alleviating Breathlessness in Cancer Patients With Dexamethasone; ClinicalTrials.gov Identifier: NCT03367156). It enrolled adult patients with cancer who were ambulatory and who had an average dyspnea intensity score of 4 or higher on an 11-point scale during the prior week, with higher values reflecting greater severity.
Participants were randomly assigned 2:1 to receive 2 weeks of either oral dexamethasone (8 mg every 12 hours for the first week, then 4 mg every 12 hours for the second week) or placebo. Patients were also stratified by dyspnea score at baseline and by study site. The primary study outcome was change in dyspnea intensity on the 11-point scale over the prior 24 hours from baseline to day 7 (±2 days).
A total of 85 participants were assigned to the dexamethasone group, and 43 participants were assigned to the placebo group. From baseline to day 7 (±2 days), the mean change in dyspnea intensity in the dexamethasone group was −1.6 (95% CI, −2.0 to −1.2) on the numerical scale, whereas mean change in dyspnea intensity in the placebo group during the same time frame was −1.6 (95% CI, −2.3 to −0.9) for a mean between-group difference of 0.0 (95% CI, −0.8 to 0.7; P =.48).
Adverse events (AEs) were reported within a median follow-up of 42 days. Common grade 3 or higher adverse effects (in the dexamethasone vs placebo groups, respectively), were infections (11% vs 7%), insomnia (8% vs 2%), and neuropsychiatric symptoms (4% vs 0%). Serious AEs resulting in hospitalization were reported in 28% vs 7% of patients in the 2 groups. No treatment-related deaths were reported.
“In summary, our data suggest that, given the risks associated with high-dose dexamethasone, it should not be routinely given to patients with cancer for alleviation of dyspnoea,” the study investigators concluded in their report. They also acknowledged there could be a subgroup of patients for whom this treatment would be beneficial.
Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Hui D, Puac V, Shelal Z, et al. Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial. Lancet Oncol. 2022;23(10):1321-1331. doi:10.1016/S1470-2045(22)00508-3