AETHERA: brentuximab vedotin consolidation after autologous stem cell transplantation in Hodgkin lymphoma at risk of relapse
Giving the antibody-drug conjugate brentuximab vedotin for up to a year after a stem cell transplant roughly doubled the time before Hodgkin lymphoma came back in patients at high risk of relapse.
Overview
International randomised double-blind placebo-controlled phase 3 trial of 329 patients with Hodgkin lymphoma at high risk of relapse after autologous stem cell transplantation (primary refractory disease, relapse within twelve months, or extranodal relapse), assigned to up to 16 cycles of brentuximab vedotin or placebo starting 30 to 45 days after transplant.
Median progression-free survival by independent review was 42.9 months with brentuximab vedotin against 24.1 months with placebo (hazard ratio 0.57); peripheral neuropathy was the main toxicity. Overall survival did not differ, partly because placebo patients received brentuximab at relapse.
- Median progression-free survival 42.9 months with brentuximab vedotin versus 24.1 months with placebo; hazard ratio 0.57.
- Peripheral sensory neuropathy in about two thirds of treated patients, mostly reversible.
Patients at high risk of relapse after autologous transplant are offered brentuximab vedotin consolidation; the benefit is largest in those with two or more risk factors.
- No overall survival benefit, with crossover at relapse.
- Patients who had already received brentuximab before transplant were excluded, which now describes many candidates.
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