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A placebo-controlled study investigating the dexamethasone-sparing effects of corticorelin acetate in patients with primary or metastatic brain tumors and peritumoral edema.


Posted on: 05/14/2009

 

A placebo-controlled study investigating the dexamethasone-sparing effects of corticorelin acetate in patients with primary or metastatic brain tumors and peritumoral edema.


 

 

Author(s): L. D. Recht, L. Mechtler, S. Phuphanich, A. Hormigo, V. Hines, R. Milsted, P. C. O'Connor, R. P. Ryan, E. T. Wong; Stanford University Medical Center, Palo Alto, CA; Dent Neurologic Institute, Amherst, NY; Cedars-Sinai Medical Center, Los Angeles, CA; Memorial Sloan-Kettering Cancer Center, New York, NY; Celtic Pharma, New York, NY; Celtic Pharma, London, United Kingdom; Beth Israel Deaconess Medical Center, Boston, MA


 

Abstract:

Background: The standard therapy for patients with peritumoral edema (PTE) associated with cerebral tumors is long-term dexamethasone (dex), which is associated with significant short- and long-term adverse events (AEs). Corticorelin acetate (CrA) is a synthetic peptide of corticotropin-releasing factor that may have the potential to allow such patients to reduce or stop dex therapy. This study investigated the steroid-sparing effect of CrA in patients with cerebral tumors and PTE. Methods: Patients were randomized to CrA 1.0 mg bid SC (n = 100) or placebo (PLA) SC (n = 100) for 12 weeks. The primary endpoint was the percentage of responders, defined as patients able to reduce their daily dex dose by ≥50% by week 2 and maintain this reduction until week 5, without deterioration in neurologic or performance status. Secondary endpoints included maximum percent dex dose reduction from baseline and proximal myopathy (Kendall Myopathy Scale). Steroid-specific treatment-emergent AEs (TEAEs) were also evaluated. Results: The groups were comparable at baseline. There were more responders in the CrA arm vs the PLA arm (62/100 vs. 47/100; p = 0.03). A maximum dex dose reduction of ≥75% was achieved by 42% of CrA patients vs 22% of PLA patients (p = 0.01). 15% of CrA patients were able to stop dex vs. 6% PLA (p = 0.04). At week 12 vs. baseline, proximal myopathy was improved in the CrA group vs the PLA group for upper limbs (p = 0.06) and lower limbs (p = 0.02). AE profiles in both groups were dominated by dex-associated side effects. The overall AE profiles of the treatment groups were generally similar. Emergent cushingoid signs were seen in 13 PLA vs 2 CrA patients (p = 0.01); 14 PLA patients reported skin/subcutaneous tissue disorders as TEAEs vs. 7 CrA patients (p = 0.07). Conclusions: CrA may benefit patients with symptoms of PTE associated with primary or metastatic cerebral tumors by allowing them to reduce/stop their dex treatment, so reducing the incidence of the steroid-related AEs of myopathy, cushingoid symptoms, and skin disorders.


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