Dexamethasone fails to relieve shortness of breath among patients with cancer
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High-dose dexamethasone failed to improve shortness of breath compared with placebo among ambulatory patients with cancer, according to study results published in The Lancet Oncology.
In addition, the researchers found increased treatment-associated adverse events associated with dexamethasone.
Background
“[Shortness of breath] is a distressing symptom that is difficult to treat, with few treatment options available,” David Hui, MD, MSc, assistant professor in the department of palliative care and rehabilitation medicine at The University of Texas MD Anderson Cancer Center, told Healio. “Dexamethasone is commonly used as a palliative measure. However, few high-quality studies have been conducted to inform clinical practice. We obtained funding from NCI to conduct this randomized trial to better understand its risks and benefits.”
The double-blind, randomized, controlled Alleviating Breathlessness in Cancer Patients with Dexamethasone trial included 128 ambulatory patients with cancer assigned 2:1 to 8 mg dexamethasone every 12 hours for 7 days followed by 4 mg dexamethasone every 12 hours for 7 days (n = 85; median age, 66 years; 59% women; 84% white; 77% with respiratory cancer) or placebo for 14 days (n = 43 median age, 63 years; 56% women; 79% white; 63% with respiratory cancer). The researchers conducted modified intention-to-treat analyses and stopped study enrollment after second preplanned interim analysis.
Change in shortness of breath numerical rating scale within the previous 24 hours from baseline to day 7 served as the primary outcome.
Findings
Researchers observed mean change in shortness of breath numerical rating scale intensity from baseline to day 7 of –1.6 for both dexamethasone (95% CI, –2 to –1.2) and placebo (95% CI, –2.3 to –0.9).
Common all-cause grade 3 to grade 4 adverse events included infection in 11% (n = 9) of patients assigned dexamethasone vs. 7% (n = 3) of patients assigned placebo, insomnia in 8% (n = 7) vs. 2% (n = 1) and neuropsychiatric symptoms in 4% (n = 3) vs. none.
Serious adverse events that resulted in hospital admissions occurred in 28% (n = 24) of patients assigned dexamethasone vs. 7% (n = 43) of patients assigned placebo, with no treatment-associated deaths in either group.
“Based on these findings, we do not recommend routine use of dexamethasone for [shortness of breath] in unselected patients with cancer,” Hui said. “However, our study was conducted in the ambulatory setting and did not include patients with specific etiologies, such as airway obstruction and lymphangitic carcinomatosis. Case reports have found that corticosteroids were useful for alleviating [shortness of breath] for these conditions.”
Future research
Further research is needed, according to Hui.
“We would like to identify predictive markers for treatment response because some patients seemed to derive some benefit,” Hui said. “Future studies of corticosteroids should consider lower doses for palliation, given the side effect profile with high-dose dexamethasone.”
For more information:
David Hui, MD, MSc, can be reached at dhui@mdanderson.org.
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