Introduction: AETHERA is a randomized, double-blind, phase 3 study of brentuximab vedotin and best supportive care (BSC) versus placebo and BSC in Hodgkin lymphoma (HL) patients at increased risk of relapse or progression post-autologous stem cell transplant (ASCT). Early consolidation post-ASCT with brentuximab vedotin demonstrated improved progression-free survival (PFS) per independent review compared with placebo (median PFS 43 vs 24 months; 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 anaemia (4% vs 2%). Treatment discontinuation due to AEs occurred in 33% vs 6% of patients, and 53 patients died on study (17% vs 16%). This analysis evaluated healthcare resource utilization (HRU) among patients on the two treatment arms of the AETHERA trial.
Methods: HL patients aged ≥18 years at high risk of residual HL post-ASCT, defined as a history of refractory HL, relapse or progression <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 on day 1 of each 21-day cycle, for up to 16 cycles or until disease progression. The total number of hospitalizations, outpatient visits and missed days of work/other activities for patients/caregivers, occurring from time of informed consent up to 24 months after the first study treatment, was summarized by treatment group in the intent-to-treat population.
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). 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. 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 hospitalization and outpatient visits were AEs and disease-related symptoms. There were 85 (52%) vs 94 (57%) patients with ≥1 missed day of work/other activities, 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 activities, with a median number of 7 vs 16 missed days.
Conclusions: Preliminary results suggest a trend towards 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.
