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Brentuximab Vedotin in Pediatric Hodgkin’s Lymphoma

Brentuximab vedotin provided “superior efficacy” in children, adolescents, and young adults with advanced-stage Hodgkin’s lymphoma when combined with multiagent chemotherapy, a phase 3 trial shows, with no increase in the incidence of toxic effects at 3 years. The CD30-directed antibody–drug conjugate has been shown effective in adults with this condition, but with greater toxicity than chemotherapy alone.

Participants in the open-label, randomized trial were 2 to 21 years of age and had previously untreated Hodgkin’s lymphoma of stage IIB with bulk tumor or stage IIIB, IVA, or IVB. They received five 21-day cycles of brentuximab vedotin with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide or the standard pediatric regimen of doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide, with these results based on a primary endpoint of event-free survival: “Of 600 patients who were enrolled across 153 institutions, 587 were eligible. At a median follow-up of 42.1 months (range, 0.1 to 80.9), the 3-year event-free survival was 92.1% (95% confidence interval [CI], 88.4 to 94.7) in the brentuximab vedotin group, as compared with 82.5% (95% CI, 77.4 to 86.5) in the standard-care group (hazard ratio for event or death, 0.41; 95% CI, 0.25 to 0.67; P <0.001). The percentage of patients who received involved-site radiation therapy did not differ substantially between the brentuximab vedotin group and the standard-care group (53.4% and 56.8%, respectively). Toxic effects were similar in the two groups. Overall survival at 3 years was 99.3% (95% CI, 97.3 to 99.8) in the brentuximab vedotin group and 98.5% (95% CI, 96.0 to 99.4) in the standard-care group.”

Editorial: “The important question is how to decrease radiation therapy in the pediatric setting,” editorialists write. “Omitting obligatory radiation therapy to bulky tumors has been successfully applied in adults and is a testable question for future clinical trials involving children. Intensification of first-line therapy with immune checkpoint inhibitors or other emerging immune-based therapies may also reduce the use of radiation therapy. Finally, to overcome false positive results on PET, new tumor-specific methods, such as assessment of circulating tumor DNA, should be studied.”

Source: New England Journal of Medicine