A new study has shown that a combination of brentuximab vedotin and standard chemotherapy is safe and appears to be more effective than standard chemotherapy in pediatric patients up to age 21 with newly diagnosed high-risk Hodgkin lymphoma. Findings from the Children's Oncology Group phase III study AHOD1331 were presented by Castellino et al at the 2022 ASCO Annual Meeting (Abstract 7504).
Brentuximab vedotin is an antibody-drug conjugate designed to selectively kill tumor cells expressing the CD30 antigen, a marker of Hodgkin lymphoma, while generally sparing healthy cells. The U.S. Food and Drug Administration has approved the use of brentuximab vedotin for the treatment of adults with advanced-stage Hodgkin lymphoma.
“We’re sincerely excited about the results from this phase III clinical trial conducted at Roswell Park and 150 other treatment centers, which was the first to establish that brentuximab vedotin in combination with chemotherapy is safe and effective in children and adolescents with high-risk Hodgkin lymphoma,” said Kara Kelly, MD, Chair of the Roswell Park Oishei Children’s Cancer and Blood Disorders Program and the Waldemar J. Kaminski Endowed Chair of Pediatrics at Roswell Park, and the study’s senior author. “The benefits we observed are pronounced enough to support a change in clinical practice.”
Study Details
The 4-year study included 587 eligible children and adolescents between the ages of 2 and 21 with newly diagnosed, previously untreated, high-risk Hodgkin lymphoma. They were randomly assigned to receive five cycles of either brentuximab vedotin combined with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide chemotherapy (AVE-PC) or standard pediatric dose-intensive regimen of bleomycin-containing chemotherapy consisting of doxorubicin, bleomycin, vincristine, etoposide, cyclophosphamide, and prednisone (ABVE-PC).
The dose-intensive regimen of brentuximab vedotin plus AVE-PC was superior to standard chemotherapy, with a 3-year event-free survival rate of 92% compared with 82%—an overall risk reduction of 59%—with no increase in toxicity and fewer patients receiving radiation therapy compared with prior pediatric trials for high-risk disease. Rates of disease relapse were lower in patients who received brentuximab vedotin plus AVE-PC (7%) than in those who received standard chemotherapy (17%). Researchers found no difference in serious adverse events or rates of myelosuppression or neuropathy between the groups.
The researchers concluded that brentuximab vedotin in combination with AVE-PC chemotherapy has superior efficacy to the standard ABVE-PC regimen in pediatric patients up to age 21 with high-risk Hodgkin lymphoma and could be used as a front-line treatment in this patient population.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
