Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse
Mené sur des patients adultes atteints d'un lymphome hodgkinien classique à haut risque de récidive ou de progression après une greffe autologue de cellules souches hématopoïétiques, cet essai de phase III évalue l'efficacité, du point de vue de la survie sans progression à 5 ans, et la toxicité du brentuximab védotin en traitement d'entretien
The phase 3 AETHERA trial established brentuximab vedotin (BV) as a consolidative treatment option for adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression following autologous hematopoietic stem cell transplant (auto-HSCT). Results showed that BV significantly improved progression-free survival (PFS) versus placebo plus best supportive care alone. At 5 years follow-up, BV continued to provide patients with sustained PFS benefit; 5-year PFS was 59% (95% CI 51-66) with BV versus 41% (95% CI 33-49) with placebo (HR 0.521, 95% CI, 0.379–0.717). Similarly, patients with ≥ 2 risk factors on the BV arm experienced significantly higher PFS at 5 years than patients in the placebo arm (HR 0.424, 95% CI 0.302-0.596). Upfront consolidation with BV significantly delayed time to second subsequent therapy, an indicator of ongoing disease control, versus placebo. Peripheral neuropathy, the most common adverse event in patients receiving BV, continued to improve and/or resolve in 90% of patients. In summary, consolidation with BV in adult patients with cHL at high risk of relapse or progression after auto-HSCT confers a sustained PFS benefit and is safe and well tolerated. Physicians should consider each patients’ HL risk factor profile when making treatment decisions. (www.clinicaltrials.gov #NCT01100502).
Blood 2018