A New Regimen for Pediatric Hodgkin Lymphoma

The anti-CD30 antibody–drug conjugate brentuximab vedotin (BV) has been incorporated into frontline therapy for adults with advanced-stage Hodgkin lymphoma (HL) and has been shown to be safe and effective in children with relapsed or refractory disease. In a randomized, multicenter, phase 3 trial, researchers compared five 3-week cycles of BV (1.8 mg/kg) plus doxorubicin, vincristine, etoposide, cyclophosphamide, and prednisone versus a standard regimen of the same chemotherapy agents plus bleomycin in patients ages 2 to 21 years with newly diagnosed bulky stage IIB, stage IIIB, or stage IVA/B HL. PET/CT was performed after cycle 2; patients with slow interim response and those with initial bulk disease received radiation therapy after completion of chemotherapy.

Of 587 patients, median age was 15.6 years; 60.1% had stage IV and 54.5% had bulky mediastinal disease. At a median follow-up of 42 months, 3-year event-free survival (EFS), the primary endpoint, was significantly improved in the BV arm compared with the standard-care arm (92.1% vs. 82.5%). Overall survival at 3 years was 99.3% and 98.5%, respectively. Among patients with slow interim response, 3-year EFS was significantly higher in the BV arm (90.7% vs. 68.3%). Twenty-three patients in the BV arm and 51 in the standard-care arm had a first event. There were no significant differences between arms in rates of radiation therapy or complete remission after chemotherapy.

No difference in grade 2 or greater peripheral neuropathy was observed between arms; fewer patients in the BV arm required dose modifications, other than to BV or vincristine, during treatment (12.8% vs. 22.5%).