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A study published in the September 16, 2015 online edition of Blood, the Journal of the American Society of Hematology (ASH), reports that brentuximab vedotin (also known as SGN-035; Adcetris®; Seattle Genetics Inc.) is an effective and safe first course of treatment for older Hodgkin lymphoma (HL) patients unfit for chemotherapy.[1][2]

While standard chemotherapy regimens can achieve complete remissions in younger Hodgkin lymphoma (HL) patients, outcomes in the majority of older patients (>60 years and older) tend to be poor. Treatment-related toxicity is significant and comorbidities often limit the available therapeutic options. Hence older patients are either ineligible or refuse treatment in order to avoid the adverse complications related to drug toxicity.

A clear unmet need
As the rate of remission is much lower for older compared to younger Hodgkin lymphoma patients, there is a clear unmet need for less toxic treatments that allow patients 60 and older to complete their full regimen without complications or interruptions.

Researchers suggest that one promising treatment is brentuximab vedotin, a therapy that targets Hodgkin lymphoma cells and delivers a potent dose of chemotherapy without harming healthy cells. In previous studies, brentuximab vedotin has achieved remissions in patients with relapsed or treatment-resistant disease.

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Clinical trial
To examine the potential of brentuximab vedotin as a first course of treatment for older Hodgkin lymphoma patients, a research team lead by Andres Forero-Torres, M.D., of the University of Alabama at Birmingham and the UAB Comprehensive Cancer Center, conducted a Phase II open-label study evaluating 26 patients (ages 64 to 92) who were either ineligible for conventional chemotherapy or declined treatment after receiving information about its risks.

Researchers administered 1.8 mg/kg of intravenous brentuximab vedotin treatment every three weeks for up to 16 doses. Those who benefitted from the drug could continue beyond this time period until disease progression, unacceptable toxicity, or study closure. Patients received a median of eight cycles, with four completing 16 and one completing 23 cycles.

Trial results
At the time of analysis, 92% of patients achieved a complete or partial response to the drug that lasted approximately 9.1 months. Of those, 73% achieved a complete remission (CR) that lasted approximately 9.2 months. The treatment was generally well-tolerated and consistent with previous reports of brentuximab vedotin in patients with relapsed and treatment-resistant Hodgkin lymphoma. The most common adverse event was peripheral sensory neuropathy (78%). Fewer than half of patients experienced fatigue and nausea.

“In this population of older patients with Hodgkin lymphoma who were unfit for standard chemotherapy, we observed that brentuximab vedotin as a single agent produced a very high rate of response, including a very high rate of complete remission,” Forero-Torres said. “While we observed promising responses, the next step is to evaluate this drug in combination with additional chemotherapy or immunotherapies that might allow us to prolong the response without relapse.”

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