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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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Date

2019-10-01

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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

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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.

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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

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administration-related reactions, follicular lymphoma, non-Hodgkin diffuse large B-cell lymphoma, rituximab, safety

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