Pharmacokinetics, efficacy, and safety of subcutaneous versus intravenous rituximab in previously untreated Chinese patients with CD20+ diffuse large B-cell lymphoma: a phase II randomized controlled trial.

Abstract

Subcutaneous (SC) rituximab has demonstrated advantages over intravenous (IV) administration; however, insufficient data exist on its use with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in Chinese patients with diffuse large B-cell lymphoma (DLBCL). This multicenter, phase II, randomized, controlled study was conducted across China between February 2021 and October 2022. Fifty adult patients with previously untreated CD20-positive DLBCL were randomized to receive one cycle of IV rituximab and seven cycles of SC rituximab (R^SC-CHOP; n = 26), or eight cycles of IV rituximab (R^IV-CHOP; n = 24), combined with six or eight cycles of CHOP. Geometric mean ratio of trough rituximab serum concentration of SC to that of IV rituximab (C_trough,SC/C_trough,IV) at cycle 7 was 1.52 (90% CI: 1.28-1.79), demonstrating non-inferiority of C_trough,SC. The complete response rate was similar in both treatment arms. SC rituximab is a viable option in Chinese patients with untreated CD20-positive DLBCL, potentially reducing administration burden (ClinicalTrials.gov identifier: NCT04660799).