Postmarketing surveillance of brentuximab vedotin for previously untreated Hodgkin lymphoma in Japanese patients.

Febrile neutropenia (FN) poses a life-threatening risk in patients with Hodgkin lymphoma (HL) undergoing treatment with brentuximab vedotin and doxorubicin, vinblastine, and dacarbazine (A+AVD), especially in elderly patients. Although primary prophylaxis with granulocyte-colony stimulating factor (G-CSF) mitigated FN risk in ECHELON-1, limited safety data exist in Japanese patients, especially regarding neutropenia and FN after A+AVD. We assessed the real-world safety of A+AVD as first-line treatment of Japanese patients with HL. This postmarketing surveillance study collected data between November 2018 and December 2022 (study registration: JRCT1080224121; NCT03729609). Data included treatment details, response, and safety (specific focus on grade ≥3 neutropenia/FN). A total of 112 patients with previously untreated HL receiving A+AVD were included in the analysis. Overall, neutropenia incidence was 58.0%, and FN incidence was 27.7%. Two FN-related deaths occurred. Within 14 days after the first dose of A+AVD, neutropenia occurred in 26.5% and 39.7% of patients with and without early G-CSF administration (EGA), respectively, and in 27.5% and 42.6% with and without prophylactic G-CSF administration (PGA), respectively. FN occurred in 26.5% and 19.2% of patients with and without EGA, respectively, and in 17.7% and 24.6% with and without PGA, respectively. Among the 96 patients with image evaluation, excluding those whose dose was not the approved dose, 89.6% achieved a partial response or better. The real-world safety profile of A+AVD aligned with prior findings, emphasizing the importance of PGA to prevent neutropenia and FN.