High-dose dexamethasone should not be used to treat dyspnea in patients with cancer, according to researchers.
In a phase 2 trial, there was no difference in dyspnea intensity for patients who received dexamethasone and those who received placebo. These results were published in The Lancet Oncology.
The trial (ClinicalTrials.gov Identifier: NCT03367156) enrolled adults with cancer who were ambulatory. They 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.
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Patients 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 stratified by dyspnea score at baseline and by study site. A total of 85 patients were assigned to the dexamethasone group, and 43 were assigned to the placebo group.
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). The mean change in dyspnea intensity was −1.6 (95% CI, −2.0 to −1.2) in the dexamethasone group and −1.6 (95% CI, −2.3 to −0.9) in the placebo group, 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 AEs (in the dexamethasone and 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% of patients in the dexamethasone group and 7% of patients in placebo group. 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 acknowledged, however, that 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.
Reference
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
This article originally appeared on Oncology Nurse Advisor
