A fusion protein therapy may be an effective treatment option for cutaneous T-cell lymphomas, according to a multicenter clinical trial published in the Journal of Clinical Oncology.
Cutaneous T-cell lymphoma is a rare cancer of T-lymphocytes, a type of immune fighter cell. It often manifests on the skin as a red, itchy rash, consisting of scaly patches, bumps or tumors on the skin.
Currently, most treatments for cutaneous T-cell lymphoma do not produce long-lasting benefits, said Timothy Kuzel, MD, ‘87 ‘90 GME, clinical professor of Medicine in the Division of Hematology and Oncology and a co-author of the study.
“Many of these patients are middle-aged, so their life expectancy otherwise would be 20 to 30 years, but the duration of response for most treatments is only 12 to 14 months, so many of these patients continue to relapse, ultimately leading to death,” Kuzel said.
This led investigators to test a new formulation of an existing protein fusion treatment, denileukin diftitox (DD)-cxdl, in patients with T-cell lymphoma who had already undergone at least one treatment for the condition.
In the study, 69 patients with cutaneous T-cell lymphoma, including the most common subtypes mycosis fungoides and Sézary syndrome, were given DD-cxdl for five consecutive days every 21 days.
Roughly 36 percent of patients responded to the treatment, with more than 8 percent achieving a complete response (complete disappearance of all evidence of the lymphoma). Study participants showed a median duration of response of more than eight months. More than 80 percent of patients experienced some decrease in skin tumor burden, according to the study, and more than half saw a decrease of 50 percent or more.
The most common side effects from the treatment included infusion reactions, hypersensitivity, liver toxicity, and capillary leak syndrome. Most adverse events were mild to moderate in severity, with few severe cases reported, according to the study.
“The lesions patients present with are in some cases quite disfiguring,” Kuzel said. “They can be itchy or painful, so patients really need more therapeutic options. And thus, the advantage of this is it’s another therapeutic option that’s different from our other existing agents that we use. It adds one more tool for the treatment of the disease.”
While the drug has since gained FDA approval, Kuzel said more research is needed to create effective combination therapies for treating the disease.
“Northwestern has an incredibly long history of being one of the leaders in the management of this rare skin lymphoma,” Kuzel said. “I’m glad to be bringing new trials and new treatment options to this population of patients.”
The study was supported by the pharmaceutical company Dr. Reddy’s Laboratories.
