Publication: 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.
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Identifiers
Date
2019-10-01
Authors
García-Muñoz, Ricardo
Quero, Cristina
Pérez-Persona, Ernesto
Domingo-García, Abel
Pérez-López, Cristina
Villaescusa-de-la-Rosa, Teresa
Martínez-Castro, Ana M
Arguiñano-Pérez, José M
Parra-Cuadrado, Juan F
Panizo, Carlos
Advisors
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Rituximab is a standard treatment for non-Hodgkin diffuse large B-cell (DLBCL) and follicular (FL) lymphomas. A subcutaneous formulation was developed to improve the resource use of intravenous rituximab, with comparable efficacy and safety profiles except for increased administration-related reactions (ARRs). MabRella was a phase IIIb trial to assess the safety of switching from intravenous to subcutaneous administration of rituximab during first-line induction/maintenance for DLBCL or FL, focusing on ARRs. Efficacy, satisfaction and quality of life were also assessed. Patients received subcutaneous rituximab plus standard induction chemotherapy for DLBCL or FL for 4-7 cycles, and/or every 2 months maintenance monotherapy for FL for 6-12 cycles. The study included 140 patients: DLBCL, n = 29; FL, n = 111. Ninety-five percent of patients experienced adverse events, reaching grade ≥3 in 38·6% and were serious in 30·0%. AARs occurred in 48·6%, mostly (84·9%) at the injection site, with only 2·1% of patients reaching grade 3. The end-of-induction complete/unconfirmed complete response rate was 69·6%. After a median follow-up of 33·5 months, median disease-/event-/progression-free and overall survivals were not attained. The Rituximab Administration Satisfaction Questionnaire showed improvements in overall satisfaction and the EuroQoL-5D a good quality-of-life perception at induction/maintenance end. Therefore, switching to subcutaneous rituximab showed no new safety issues and maintained efficacy with improved satisfaction and quality of life.
Description
MeSH Terms
Administration, Intravenous
Adolescent
Adult
Aged
Aged, 80 and over
Disease-Free Survival
Female
Humans
Infusions, Subcutaneous
Lymphoma, Large B-Cell, Diffuse
Male
Middle Aged
Quality of Life
Rituximab
Safety
Spain
Survival Rate
Adolescent
Adult
Aged
Aged, 80 and over
Disease-Free Survival
Female
Humans
Infusions, Subcutaneous
Lymphoma, Large B-Cell, Diffuse
Male
Middle Aged
Quality of Life
Rituximab
Safety
Spain
Survival Rate
DeCS Terms
CIE Terms
Keywords
administration-related reactions, follicular lymphoma, non-Hodgkin diffuse large B-cell lymphoma, rituximab, safety