Brentuximab Vedotin Plus Chemotherapy in North American Patients with Newly Diagnosed Stage III or IV Hodgkin Lymphoma. Clinical cancer research : an official journal of the American Association for Cancer Research Ramchandren, R., Advani, R. H., Ansell, S. M., Bartlett, N. L., Chen, R., Connors, J. M., Feldman, T., Forero, A., Friedberg, J. W., Gopal, A. K., Gordon, L. I., Kuruvilla, J., Savage, K. J., Younes, A., Engley, G., Manley, T. J., Fenton, K., Straus, D. J. 2019


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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