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.
Subject(s)
Lymphoma, Large B-Cell, Diffuse/drug therapy , Lymphoma, Large B-Cell, Diffuse/mortality , Quality of Life , Rituximab/administration & dosage , Safety , Administration, Intravenous , Adolescent , Adult , Aged , Aged, 80 and over , Disease-Free Survival , Female , Humans , Infusions, Subcutaneous , Male , Middle Aged , Rituximab/adverse effects , Spain/epidemiology , Survival RateABSTRACT
Introducción. La enfermedad fúngica invasora (EFI) es una importante causa de morbimortalidad en pacientes hematológicos. La profilaxis antifúngica (PAF) está indicada en muchos episodios de este grupo de pacientes. El objetivo de este trabajo fue alcanzar un consenso sobre el abordaje profiláctico de las EFI en el paciente hematológico con el fin de optimizar su manejo. Métodos. Un comité de expertos en hematología y enfermedades infecciosas planteó un cuestionario de 79 ítems con aspectos controvertidos sobre la profilaxis antifúngica en el paciente hematológico. El cuestionario fue evaluado en dos rondas por un panel de expertos siguiendo una metodología Delphi modificada. Resultados. El cuestionario fue respondido por 44 expertos en hematología y enfermedades infecciosas. Tras dos rondas de evaluación se consensuaron 48 ítems en el acuerdo (60,7%) y 19 en el desacuerdo (24%) por lo que hubo consenso en 67 de los 79 ítems planteados (84,8%). Se consensuaron los perfiles de pacientes candidatos a profilaxis y se dilucidaron cuestiones relacionadas con indicaciones, mecanismos de acción, espectro de actividad, toxicidad e interacciones de los antifúngicos. Se analizó particularmente la utilidad de micafungina como profilaxis de EFI. Se consensuó que micafungina es un antifúngico a considerar en este contexto. Puede presentar ventajas sobre otros antifúngicos por su seguridad y menor potencial de interacciones. Conclusiones. Se encontró un alto nivel de consenso en el manejo de la profilaxis de la EFI en el paciente hematológico. Este consenso ofrece indicaciones prácticas sobre su manejo óptimo y puede ayudar a determinar el perfil de los pacientes idóneos a recibir este tipo de intervención (AU)
Introduction. Invasive fungal disease (IFD) is an important cause of morbidity and mortality in haematological patients. Antifungal prophylaxis (AFP) is indicated for a number of clinical scenarios in this group of patients. The aim of this study was to reach a consensus on IFD prophylaxis in haematological patients in order to optimize their management. Methods. A committee of experts in haematology and infectious diseases compiled a survey of 79 items with controversial aspects about antifungal prophylaxis in haematological patients. The survey was evaluated in two rounds by a panel of experts following a modified Delphi methodology. Results. Forty-four experts in haematology and infectious diseases answered the survey. After two evaluation rounds, consensus was reached in 67 of the 79 items (84.8%), specifically 48 items were consensually agreed on (60.7%) and 19 were disagreed on (24.0%). Consensus was reached on prophylaxis candidates profiles and questions related to indications, mechanisms of action, spectrum of activity, toxicity and interactions of antifungal were elucidated. The usefulness of micafungin in IFD prophylaxis was particularly analysed. The consensus reached was that micafungin is an antifungal to be considered in this context as its safety profile and lower interaction potential may be advantageous. Conclusions. A broad consensus was found in the management of IFD prophylaxis in the haematological patient. This consensus provides practical indications about its optimal management and can help determine the profile of patients eligible for this type of intervention (AU)
