Brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone as frontline treatment for patients with CD30-positive B-cell lymphomas
Jakub Svoboda, Steven M. Bair, Daniel J. Landsburg, Sunita D. Nasta, Sarah Nagle, Stefan K. Barta, Nadia Khan, Joanne Filicko-O’Hara, Sameh Gaballa, Lauren E. Strelec, Elise A. Chong, Sheryl Mitnick, Terease S. Waite, Cara M King, Hatcher J. Ballard, Matthew R. Youngman, James N. Gerson, John P. Plastaras, Amit Maity, Agata M. Bogusz, Stacy Hung, Hisae Nakamura, Reza Nejati, Christian Steidl, Megan S. Lim, Marco Ruella, Stephen J. Schuster
Abstract
We conducted a phase I/II multicenter trial using 6 cycles of brentuximab vedotin (BV) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for treatment of patients with CD30-positive (+) B-cell lymphomas. Thirty-one patients were evaluable for toxicity and 29 for efficacy including 22 with primary mediastinal B-cell lymphoma (PMBCL), 5 with diffuse large B-cell lymphoma (DLBCL), and 2 with gray zone lymphoma (GZL). There were no treatment-related deaths; 32% of patients had non-hematological grade 3/4 toxicities. The overall response rate was 100% (95% CI: 88-100) with 86% (95% CI: 68-96) of patients achieving complete response at the end of systemic treatment. Consolidative radiation following end of treatment response assessment was permissible and used in 52% of all patients including 59% of patients with PMBCL. With a median follow-up of 30 months, the 2-year progression-free survival (PFS) and overall survival (OS) were 85% (95% CI: 66-94) and 100%, respectively. In the PMBCL cohort, 2-year PFS was 86% (95% CI: 62-95). In summary, BV-R-CHP with or without consolidative radiation is a feasible and active frontline regimen for CD30+ B-cell lymphomas (NCT01994850).