Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial

作者：Peter Borchmann, Justin Ferdinandus, Gundolf Schneider, Alden A. Moccia, Richard Greil, Mark P. Hertzberg, Valdete Schaub, Andreas Hüttmann, Felix Keil, Judith Dierlamm, Mathias Hänel, Urban Novak, Julia Meißner, Andreas Zimmermann, Stephan Mathas, Josée M. Zijlstra, Alexander Fosså, Andreas Viardot, Bernd Hertenstein, Sonja Martin, Pratyush Giri, Sebastian Scholl, Max S. Topp, Wolfram E Jung, Vladan Vučinić, Hans-Joachim Beck, Andrea Kerkhoff, Benjamin Unger, Andreas Rank, Roland Schroers, Christian Meyer zum Büschenfelde, Maike de Wit, Karolin Trautmann-Grill, Peter Kamper, Daniel L. Molin, Stefanie Kreissl, Helen Kaul, Bastian von Tresckow, Sven Borchmann, Karolin Behringer, Michael Fuchs, Andreas Rosenwald, Wolfram Klapper, Hans‐Theodor Eich, Christian Baues, Athanasios Zomas, Michael Hallek, Markus Dietlein, Carsten Kobe, Volker Diehl · 发表于：The Lancet · 年份：2024 · DOI：10.1016/s0140-6736(24)01315-1 · 被引用次数：139 · 研究领域：Lymphoma Diagnosis and Treatment、Radiopharmaceutical Chemistry and Applications、CAR-T cell therapy research

Background Intensified systemic chemotherapy has the highest primary cure rate for advanced-stage, classical Hodgkin lymphoma but this comes with a cost of severe and potentially life long, persisting toxicities. With the new regimen of brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (BrECADD), we aimed to improve the risk-to-benefit ratio of treatment of advanced-stage, classical Hodgkin lymphoma guided by PET after two cycles. Methods This randomised, multicentre, parallel, open-label, phase 3 trial was done in 233 trial sites across nine countries. Eligible patients were adults (aged ≤60 years) with newly diagnosed, advanced-stage, classical Hodgkin lymphoma (ie, Ann Arbor stage III/IV, stage II with B symptoms, and either one or both risk factors of large mediastinal mass and extranodal lesions). Patients were randomly assigned (1:1) to four or six cycles (21-day intervals) of escalated doses of etoposide (200 mg/m 2 intravenously on days 1–3), doxorubicin (35 mg/m 2 intravenously on day 1), and cyclophosphamide (1250 mg/m 2 intravenously on day 1), and standard doses of bleomycin (10 mg/m 2 intravenously on day 8), vincristine (1·4 mg/m 2 intravenously on day 8), procarbazine (100 mg/m 2 orally on days 1–7), and prednisone (40 mg/m 2 orally on days 1–14; eBEACOPP) or BrECADD, guided by PET after two cycles. Patients and investigators were not masked to treatment assignment. Hierarchical coprimary objectives were to show (1) i...