Evaluating the safety and effectiveness of brentuximab vedotin for children with high-risk Hodgkin lymphoma.

This study investigated the safety and effectiveness of incorporating brentuximab vedotin (BV; Adcetris) as a substitution for vincristine in the OEPA (vincristine, etoposide, prednisone, doxorubicin) or COPD (cyclophosphamide, vincristine, prednisone, dacarbazine) chemotherapy regimen in children with high-risk classical Hodgkin lymphoma (cHL). The data showed that replacing BV in these regimens was safe and effective for these patients and reduced the need for radiation treatment.

Chemotherapy regimens for pediatric patients with cHL are different from regimens given to adult patients. For children, combined modality treatment (CMT) is used. CMT combines chemotherapy with radiation therapy (RT). OEPA and COPD are two regimens usually given to children with HL. Although these regimens have excellent outcomes, there are risks of long-term side effects.

BV is an immune therapy approved for use in adults with cHL. BV has shown to be effective with manageable side effects in these patients. However, whether replacing vincristine in the OEPA/COPD regimens with BV is safe and effective for children and adolescents with cHL is not known.

This study involved 77 children and adolescents with cHL. All patients were given chemotherapy consisting of two cycles of OEPA followed by four cycles of COPD with BV in the place of vincristine. After the first two cycles of chemotherapy, patients were evaluated for response to treatment with a CT or MRI scan. After this, patients who did not have a complete remission (CR; complete disappearance of the cancer) were given RT. The average follow-up time was 3.4 years.

35.1% of the patients had a CR at the first evaluation and finished treatment without RT. Overall, 98.7% of patients were alive after 3 years. 97.4% of the patients survived without any worsening of cancer or cancer coming back.

The most common side effects were vomiting, constipation, and low white blood cell count. 4% of patients had neuropathy (numbness or tingling in the limbs, hands, or feet).

This study concluded that incorporating BV into a well-established chemotherapy regimen was a safe and highly effective treatment in children with high-risk cHL.

The sample size and follow-up time were very short. There was no placebo or a control group to evaluate the effects of the treatment.