Routine dexamethasone is not effective compared to placebo to treat dyspnea in patients with advanced cancer

1. There is no significant difference for perceived dyspnea in patients taking dexamethasone as compared to placebo.

2. Cancer patients with dyspnea taking dexamethasone had worse anxiety/depression scores than those taking placebo.

Evidence Rating Level: 1 (Excellent)

Study Rundown: A large proportion of patients with advanced cancer experience dyspnea. This randomized controlled study aimed to compare dexamethasone with placebo in the alleviation of dyspnea in patients with advanced cancers. The primary outcome of interest was the change in dyspnea numerical rating scale (NRS) from day 0 to day 7, and secondary outcomes included change in anxiety/depression scores, as well as safety outcomes as indicated by adverse events (AEs). In the dexamethasone group, the mean change in dyspnea NRS from day 0 to day 7 was not significantly different from that of the placebo group (-1.6 in both groups). Patients receiving dexamethasone scored worse on the Edmonton Symptom Assessment System (ESAS) at day 7 for anxiety and depression than those receiving placebo. Regarding safety, the most common treatment-related adverse events (AEs) included infections, insomnia, neuropsychiatric symptoms, and respiratory distress, among others, and occurred more frequently in patients receiving dexamethasone. AEs requiring hospital admission occurred in 28% of dexamethasone group patients and 7% of placebo group patients. There were 15 patients in the dexamethasone group and 3 in the placebo group who discontinued treatment due to AEs. No treatment-related deaths occurred in either group. Limitations to this study include a heterogenous population on outpatients only, it suspected patients with patients with more severe symptoms or high inflammatory indices may still derive benefit but not captured in this trial. Additionally, as the study met futility criteria early on, it was not powered to detect differences in some of the secondary outcomes. Overall, the results from this study suggest that dexamethasone should not be routinely prescribed to cancer patients with dyspnea.

Click to read the study in The Lancet Oncology

Relevant Reading: Management of dyspnea in advanced cancer: ASCO guideline

In-Depth [randomized controlled trial]: This randomized controlled trial was conducted out of 2 healthcare centres the United States. The study randomly assigned 128 adult cancer patients with dyspnea in a 2:1 ratio to receive either dexamethasone or placebo. There were 85 patients in the dexamethasone group and 43 in the placebo group. In the dexamethasone group, the mean change in dyspnea NRS was -1.6 (95% CI, -2.0 to -1.2) while in the placebo group it was -1.6 (95% CI, -2.3 to -0.9) and there was no significant difference detected between the groups (mean 0.0, 95%, -0.8 to 0.7). The median change in ESAS anxiety and depression scores at day 7 were worse in patients receiving dexamethasone as compared to those taking placebo. Median change in depression scores for dexamethasone patients were 0.0 (inter-quartile range (IQR), 0.0-0.0) compared to patients on placebo at 0.0 (IQR, -2.0-0.0) and a mean difference of 0.9 (95% confidence interval (CI), 0.1-1.7). Median change in anxiety scores for patients on dexamethasone were 0.0 (IQR, -1.0-2.0) and on placebo were 0.0 (IQR, -1.0-0.0) with a mean difference of 1.1 (95% CI, 0.3-1.9).

Image: PD

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