RT Journal Article
T1 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.
A1 García-Muñoz, Ricardo
A1 Quero, Cristina
A1 Pérez-Persona, Ernesto
A1 Domingo-García, Abel
A1 Pérez-López, Cristina
A1 Villaescusa-de-la-Rosa, Teresa
A1 Martínez-Castro, Ana M
A1 Arguiñano-Pérez, José M
A1 Parra-Cuadrado, Juan F
A1 Panizo, Carlos
K1 administration-related reactions
K1 follicular lymphoma
K1 non-Hodgkin diffuse large B-cell lymphoma
K1 rituximab
K1 safety
AB 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.
YR 2019
FD 2019-10-01
LK http://hdl.handle.net/10668/14571
UL http://hdl.handle.net/10668/14571
LA en
DS RISalud
RD Apr 6, 2025