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.

Autor: García-Muñoz R; Department of Haematology, Complejo Hospitalario San Millán-San Pedro, Logroño, Spain., Quero C; Department of Medical Oncology, Hospital Universitario Virgen de la Victoria, Málaga, Spain., Pérez-Persona E; Department of Haematology, Hospital de Txagorritxu, Vitoria-Gasteiz, Spain., Domingo-García A; Department of Haematology, Hospital General de Granollers, Granollers, Spain., Pérez-López C; Department of Haematology, Hospital Universitario Clínico San Carlos, Madrid, Spain., Villaescusa-de-la-Rosa T; Department of Haematology, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain., Martínez-Castro AM; Department of Haematology, Complejo Hospitalario Universitario de Vigo, Vigo, Spain., Arguiñano-Pérez JM; Department of Haematology, Hospital de Navarra, Pamplona, Spain., Parra-Cuadrado JF; Medical Department, Roche Farma S.A., Madrid, Spain., Panizo C; Department of Haematology, Clínica Universidad de Navarra, Pamplona, Spain.
Jazyk: angličtina
Zdroj: British journal of haematology [Br J Haematol] 2020 Mar; Vol. 188 (5), pp. 661-673. Date of Electronic Publication: 2019 Oct 01.
DOI: 10.1111/bjh.16227
Abstrakt: 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.
(© 2019 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
Databáze: MEDLINE
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