Subcutaneous rituximab has similar efficacy and safety as the intravenous (IV) formulation for the first-line treatment of follicular lymphoma (FL), according to a study published in Lancet Haematology.1
The standard of care for FL is IV rituximab, but its infusion lasts up to 6 hours. The purpose of this trial was to determine whether a subcutaneous formulation had non-inferior pharmacokinetics and a similar efficacy and safety profile.
The open-label, 2-stage, phase 3 SABRINA (ClinicalTrials.gov Identifier: NCT01200758) trial randomly assigned 410 adult patients with treatment-naïve CD20-positive, grade 1 to 3a FL to receive chemotherapy plus rituximab 375 mg/m2 IV or 1400 mg subcutaneously. All patients, however, received IV rituximab during their first cycle to evaluate for and manage adverse reactions.
The median age was 56.5; 86% of patients were white. The chemotherapy regimen contained cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) among 63% of patients, with the remaining 37% receiving cyclophosphamide, vincristine, and prednisolone (CVP). The majority of patients had grade 2 FL, followed by grade 1 and then grade 3a.
The overall response was similar in both groups, with 84.9% (95% CI, 79.2-89.5%) in the IV arm and 84.4% (95% CI, 78.7-89.1%) in the subcutaneous arm. Complete response was achieved by 66% in both arms.
The rate of grade 3 or higher adverse events (AEs) was 55% and 56% in the IV and subcutaneous arms, respectively, with the most common being neutropenia. The rate of serious AEs was also similar between arms (37% vs 35%, respectively). There were no new safety signals.
The rate of administration reactions was higher in the subcutaneous arm (48%) compared with the IV arm (35%), primarily due to grade 1 to 2 local injection-site reactions.
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According to the authors, these results indicate that “subcutaneous administration does not compromise the anti-lymphoma activity of rituximab when given with chemotherapy.”
- Davies A, Merli F, Mihaljevic B, et al. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol. 2017 May 2. doi: 10.1016/S2352-3026(17)30078-9 [Epub ahead of print]