Background: Brentuximab vedotin received approval for the treatment of relapsed/refractory Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or = 2 prior therapies. AETHERA is a randomized, double-blind, Phase 3 study of brentuximab vedotin and best supportive care (BSC) versus placebo and BSC for patients at increased risk of HL relapse or progression following ASCT. Brentuximab vedotin consolidation therapy post-ASCT substantially improved progression-free survival (PFS) per independent review with a median PFS of 43 months in the brentuximab vedotin arm compared with 24 months in the placebo arm (HR=0.57, P=0.001). The most common treatment-emergent grade = 3 adverse events (AEs) were neutropenia (29% brentuximab vedotin vs 10% placebo), peripheral sensory neuropathy (10% vs 1%), thrombocytopenia (4% vs 3%), peripheral motor neuropathy (6% vs 1%), and anemia (4% vs 2%). Treatment discontinuation due to AEs occurred in 33% vs 6% of patients, and 53 patients died on-study (17% vs 16%). High risk patients who relapse post-ASCT often report a high disease and treatment burden requiring healthcare intervention.
Aims: To compare the healthcare resource utilization (HRU) associated with brentuximab vedotin and placebo for the treatment of patients at risk of HL progression post-ASCT in the AETHERA trial.
Methods: HL patients aged greater than or equal to 18 years at high risk for post-ASCT disease progression, defined as a history of refractory HL, relapse or progression less than 12 months after frontline therapy, or extranodal involvement at the time of pre-ASCT relapse, were eligible. Patients were randomized to receive brentuximab vedotin 1.8 mg/kg or placebo via IV infusion on day 1 of each 21-day cycle, for a maximum of 16 cycles or until disease progression. All medical care encounters that occurred from time of informed consent up to 24 months post first study treatment were collected for the intent-to-treat population. The total number of hospitalizations, outpatient visits, and the number of missed days of work/other activity for patients or caregivers, were summarized by treatment group.
Results: A total of 329 patients (median age 32 years [range 18–76]; 53% male) were randomized to receive brentuximab vedotin (n=165) or placebo (n=164) at 78 sites in the USA and Europe. There were 68 (41%) vs 61 (37%) patients with =1 hospitalization on the brentuximab vedotin vs placebo arms, respectively, with a total of 176 vs 198 hospitalizations. The hospitalization rate per patient-year was 0.58 (95% CI: 0.49, 0.67) vs 0.65 (95% CI: 0.56, 0.74). The median duration of stay was 16 vs 26 days per patient. The most common reasons for hospitalization were disease-related signs and symptoms (36% vs 40%) and AEs (29% vs 15%). There were 119 (72%) vs 133 (81%) patients with = 1 outpatient visit, with a total of 2687 vs 3803 visits. The outpatient visit rate per patient-year was 8.84 (95% CI: 8.51, 9.18) vs 12.43 (95% CI: 12.03, 12.82). The most common reasons for outpatient visits were disease-related signs and symptoms (36% vs 42%) and AEs (22% vs 14%). There were 85 (52%) vs 94 (57%) patients with = 1 missed day of work/other activity, with a median number of 15 vs 26 missed days. There were 7 (4%) vs 24 (15%) caregivers with = 1 missed day of work/other activity, with a median number of 7 vs 16 missed days.
Summary: Preliminary results suggest a trend toward lower HRU with brentuximab vedotin compared with placebo. These data prompt further investigation of the economic impact of early consolidation post-ASCT with brentuximab vedotin in HL.
