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The New England Journal of MedicineBrentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkin’s Lymphoma

Enhancing Pediatric Hodgkin’s Lymphoma Treatment: The Brentuximab Vedotin Breakthrough

A pivotal phase 3 trial has illuminated the efficacy and safety of incorporating brentuximab vedotin, a CD30-directed antibody-drug conjugate, into the treatment regimen for children and adolescents with advanced-stage Hodgkin’s lymphoma. This research marks a significant stride in tailoring therapy to enhance outcomes in this demographic, offering a comparative perspective against standard chemotherapy regimens.

Study Design:

  • Type: Open-label, multicenter, randomized, phase 3 trial.
  • Participants: 587 patients aged 2 to 21 with previously untreated Hodgkin’s lymphoma (stages IIB with bulk tumor, IIIB, IVA, or IVB).
  • Intervention: Brentuximab vedotin combined with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide versus a standard pediatric regimen.
  • Duration: Five 21-day cycles with involved-site radiation therapy administered post fifth cycle to select patients.
  • Primary endpoint: Event-free survival.

Key Findings:

  • The 3-year event-free survival rate was significantly higher in the brentuximab vedotin group (92.1%) compared to the standard-care group (82.5%).
  • Hazard ratio for event or death: 0.41 (indicating a 59% lower risk in the brentuximab vedotin group).
  • Overall survival at 3 years: 99.3% in the brentuximab vedotin group versus 98.5% in the standard-care group.
  • No significant increase in toxic effects between the two groups.

HCN Medical Memo
The efficacy of this targeted therapy approach in children and adolescents with Hodgkin’s lymphoma was unclear until this study, which showed the addition of brentuximab vedotin to standard chemotherapy resulted in superior efficacy, with a 59% lower risk of an event or death, and no increase in the incidence of toxic effects at 3 years.

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