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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
Author(s) -
GarcíaMuñoz Ricardo,
Quero Cristina,
PérezPersona Ernesto,
DomingoGarcía Abel,
PérezLópez Cristina,
VillaescusadelaRosa Teresa,
MartínezCastro Ana M.,
ArguiñanoPérez José M.,
ParraCuadrado Juan F.,
Panizo Carlos
Publication year - 2020
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.16227
Subject(s) - medicine , rituximab , adverse effect , follicular lymphoma , population , quality of life (healthcare) , lymphoma , surgery , neutropenia , refractory (planetary science) , subcutaneous injection , oncology , chemotherapy , physics , nursing , environmental health , astrobiology
Summary 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.