For older patients with Hodgkin lymphoma with previously untreated disease, the addition of brentuximab vedotin (Bv) before and after standard doxorubicin, vinblastine, and dacarbazine (AVD) showed survival benefit and favorable safety in a phase II trial (ClinicalTrials.gov Identifier: NCT01476410).1 Trial results were published online September 4, 2018, in the Journal of Clinical Oncology.
A total of 48 participants with previously untreated Hodgkin lymphoma (stage II-IV) were enrolled between 2012 and 2016 in the single-arm, open-label trial. All participants were aged 60 years or older with a median age of 69. Participants received 2 lead-in doses of Bv (1.8 mg/kg once every 3 weeks) followed by 6 cycles of AVD chemotherapy and then 4 consolidation doses of Bv in responding patients.
About half (52%) of participants completed all treatment cycles; 73% of participants received at least 1 Bv consolidation dose. For participants who completed all treatment cycles, the median Cumulative Illness Rating Scale for Geriatrics was 4 points lower than for patients who did not (4 vs 8; P= .03).
For the intent-to-treat population (48 participants), the 2-year event-free survival rate was 80% (95% CI, 65%-89%), the 2-year progression-free survival was 84% (95% CI, 69%-92%), and 2-year overall survival was 93% (95% CI, 80%-98%).
In total, 20 of 48 patients (42%) reported a grade 3 or 4 adverse event, with the most common being neutropenia (44%), febrile neutropenia and pneumonia (8%), or diarrhea (6%). One-third of participants had grade 2 peripheral neuropathy, which for most participants, was reversible.
“Altogether, sequential Bv-AVD was well tolerated and was associated with robust outcomes,” the study authors wrote.
- Evens AM, Advani RH, Helenowski IB, et al. Multicenter phase II study of sequential brentuximab vedotin and doxorubicin, vinblastine, and dacarbazine chemotherapy for older patients with untreated classical Hodgkin lymphoma [published online September 4, 2018]. J Clin Oncol. doi: 10.1200/JCO.2018.79.0139