PURPOSE: To evaluate safety and efficacy outcomes for subjects on the ECHELON-1 study treated in North America (NA).EXPERIMENTAL DESIGN: ECHELON-1 is a global, open-label, randomized phase 3 study comparing doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (A+AVD) versus ABVD (AVD+bleomycin) as frontline therapy in subjects with Stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490). Subjects were randomized 1:1 to receive A+AVD or ABVD intravenously on Days 1 and 15 of each 28-day cycle for up to 6 cycles.RESULTS: The NA subgroup consisted of 497 subjects in the A+AVD (n=250) and ABVD (n=247) arms. Similar to the primary analysis based on the intent-to-treat population, the primary endpoint (modified progression-free survival [PFS] per independent review) demonstrated an improvement among subjects who received A+AVD compared with ABVD (HR=0.60; P=.012). For PFS, the risk of progression or death was also reduced (HR=0.50; P=.002). Subsequent anticancer therapies were lower in the A+AVD arm. Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared to ABVD. Noted differences between arms included higher rates of febrile neutropenia (20% vs. 9%) and peripheral neuropathy (80% vs. 56%), but lower rates of pulmonary toxicity (3% vs. 10%) in subjects treated with A+AVD versus ABVD.CONCLUSIONS: The efficacy benefit and manageable toxicity profile observed in the NA subgroup of ECHELON-1 support A+AVD as a frontline treatment option for Stage III or IV cHL patients.
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