A study involving use of brentuximab vedotin (BV) suggested high tolerability and favorable outcomes when used as a component of therapy for pediatric patients with classical Hodgkin lymphoma (HL). Results of the study were recently published in the Journal of Clinical Oncology.
This single-arm, open-label multicenter trial (ClinicalTrials.gov Identifier: NCT01920932) involved patients 18 years of age or younger who had stage IIB, IIIB, or IV classical HL. Patients were given BV with etoposide, prednisone, and doxorubicin (AEPA) for 2 cycles of 28 days each and BV with cyclophosphamide, prednisone, and dacarbazine (CAPDac) for 4 cycles of 21 days each.
Following 2 cycles of therapy, an early response assessment (ERA) was conducted, at which point any nodal sites that had not reached complete response were subjected to 25.5 Gy of radiotherapy 2 to 4 weeks after chemotherapy. Primary efficacy objectives were complete remission at the ERA, in addition to 3-year event-free survival (EFS) and overall survival (OS) rates.
The trial had a total of 77 participants, with a median age of 16 years (range, 6-19) at diagnosis. Stage IIB disease was found in 17% of patients, with stage IIIB disease in 25%, stage IVA disease in 16%, and stage IVB disease in 43%.
Complete remission at the ERA was reached by 35.1% of patients, which resulted in them not requiring radiation. Remaining patients were given radiation to nodal sites that had not achieved complete remission, with the exception of 1 patient who had refused radiation and 1 patient who had died prior to radiation.
The 3-year EFS rate was 97.4%, and the OS rate was 98.7%. The median follow-up was 3.4 years. There was disease progression in 1 patient who had received radiation, but this patient was reported to be free of disease for over 6 years after receiving salvage therapy.
Hematologic events were the most common adverse events. Platelet transfusions were given to 2.6% of patients, red blood cell transfusions were given 17%, filgrastim was given to 25%, and febrile neutropenia reportedly led to hospitalizations in 10%. Grade 3 neuropathic or nonneuropathic pain events were reported in 4% of patients. An 11-year-old patient with stage IVB disease unexpectedly died of ventricular tachycardia during chemotherapy.
“In conclusion, AEPA-CAPDac was highly tolerable, facilitated reduction in radiation exposure, and yielded superior 3-year EFS and OS compared with previously published trials for pediatric patients with high-risk HL,” the study investigators concluded in their report. The trial results supported further study in a randomized trial, according to the investigators.
Disclosure: Several study authors declared affiliations with the biotech or pharmaceutical industries. Please see the original reference for a full list of authors’ disclosures.
Metzger ML, Link MP, Billett AL, et al. Excellent outcome for pediatric patients with high-risk Hodgkin lymphoma treated with brentuximab vedotin and risk-adapted residual node radiation. J Clin Oncol. Published online April 7, 2021. doi:10.1200/JCO.20.03286