Switching from intravenous to subcutaneous administration of rituximab for non-Hodgkin diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) resulted in similar efficacy with no new safety issues, according to results of the MabRella study out of Spain.
“Most patients preferred subcutaneous dosing and satisfaction seemed to improve after switching to subcutaneous rituximab – especially in terms of psychological status, impact of daily living, convenience and overall satisfaction,” Ricardo Garcia-Munoz, of Complejo Hospitalario San Millan-San Pedro, Spain, and colleagues wrote in British Journal of Hematology.
The intravenous formulation of rituximab was associated with several inconveniences, according to the study. These included the requirement of intravenous access, long infusion times, and infusion-related side effects. The subcutaneous formulation was developed to overcome these inconveniences.
This phase 3b study included 140 patients (111 with follicular lymphoma) who received subcutaneous rituximab plus standard induction chemotherapy for four to seven cycles and/or every two months rituximab monotherapy as maintenance, according to the results.
Patients with DLBCL or follicular lymphoma received a median of six induction cycles and those with follicular lymphoma received a median of 11 maintenance cycles, the data showed.
The majority (95%) of patients experienced at least one adverse event, most commonly erythema, neutropenia, and asthenia. Grade 3 or worse adverse events occurred in 38.6% of patients and were considered related to subcutaneous rituximab in about half of the cases, the authors wrote.
Administration-related reactions occurred in 48.6% of patients, most commonly at the injection site. These events were grade 3 or worse in 2.1% of patients, they added.
“Most of these administration-related reactions resolved spontaneously, as drug delay was only reported in one patient and no treatment discontinuation was required,” the researchers wrote.
The end-of-induction complete/unconfirmed complete response rate was 69.6%. With a median follow-up of 33.5 months, the median disease-free, event-free, progression-free, and overall survivals were not yet reached.
“Although our findings should be considered with caution due to the fact that the study was primarily designed to assess treatment safety and the limited data on post-induction response assessment, results from other clinical trials also showed that the subcutaneous formulation enabled rituximab efficacy to be maintained during first-line treatment of these types of lymphomas,” the researchers wrote.
About 60% of patients who received subcutaneous treatment completed the EQ-5D questionnaire. In it, most patients reported no problems with mobility, self-care, or doing their usual activities. Patients also reported no problems with pain/discomfort or anxiety/depression, the study added.
Garcia-Munoz R, Quero C, Perez-Persona E, et al. Safety of switching from intravenous to subcutaneous rituximab during first‐line treatment of patients with non‐Hodgkin lymphoma: the Spanish population of the MabRella study. British Journal of Haematology. Published online October 1, 2019.