Corticorelin acetate shows promise in peritumoral brain edema
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Corticorelin acetate was associated with encouraging response rates in a cohort of patients with peritumoral brain edema, according to results of a prospective study.
Researchers investigated safety and efficacy outcomes for corticorelin acetate in a cohort of 200 patients with malignant brain tumors requiring chronic administration of dexamethasone for management of the signs and symptoms of peritumoral brain edema.
Eligible participants in the randomized, double blind study had been administered a stable dose of dexamethasone. The proportion of patients who demonstrated a response to treatment served as the primary endpoint. This was defined as a ≥50% dexamethasone reduction from baseline and a stable or improved neurologic examination score and Karnofsky performance score by the second week that was maintained through week 5.
The initial decrease of the drug dosage was a 50% reduction over 2 weeks. This level was then held for 3 more weeks.
One hundred patients received twice-daily subcutaneous injections of 1 mg corticorelin acetate, and 100 patients received placebo.
The response rate was 57% in the study drug group and 46% in the placebo group, which the researchers noted was a clinically important but not statistically significant difference (P=.12).
The maximum percent reduction in dexamethasone dose achieved during the study was 62.7% in the corticorelin acetate group and 51.4% in the placebo group, which was a significant difference (P<.001).
Improvements in myopathy were reported in the study drug group, along with a reduced likelihood of developing signs of Cushing’s syndrome.
“[Corticorelin acetate] enables a reduction in steroid requirement for patients with [peritumoral brain edema] and is associated with a reduction in the incidence and severity of common steroid adverse effects, including myopathy,” the researchers concluded.