Rapid Infusion Rituximab in Maintenance Therapy: Is It Feasible?

Abstract

4973 Background/Rationale: Rituximab is an anti-CD-20 monoclonal antibody used in the management of lymphoproliferative disorders. Rituximab is indicated in maintenance therapy for follicular cell lymphoma and can be administered once every 2 months, once every 3 months, or weekly for 4 weeks every 6 months. The use of maintenance rituximab has improved progression free survival and overall survival in low grade follicular lymphomas. Although rapid rituximab infusions have been studied extensively, there is little data on the use of rapid infusions during maintenance therapy for low grade lymphomas. Herein we report our experience with rapid infusion rituximab in patients receiving maintenance therapy. Methods: All patients who received rapid infusion rituximab as maintenance therapy for low grade lymphoma between December 2007 and June 2011 were included. Patients were considered eligible for rapid infusions if they tolerated previous rituximab infusions and presented with a peripheral lymphocyte count of less than 4.8 k/μl. Rapid rituximab infusions were administered over 90 minutes (150 mL/hr for 30 minutes and then increased to 275 mL/hr until completion). Patients were monitored for signs and symptoms of reactions. In case of an infusion reaction supportive care medications were readily available. Demographic, laboratory and clinical data were collected. Adverse events were assessed through vital signs, symptoms of infusion related reaction and supportive care measures administered and graded according to the Common Terminology Criteria for Adverse Events Version 4. The primary and secondary objectives of this retrospective study were to evaluate the incidence of grade 3/4 and all grade infusion reactions with rapid rituximab infusions during maintenance therapy, respectively. Maintenance schedules were also compared with regards to incidence of infusion reactions. Results: A total of 105 patients received 629 rapid rituximab infusions. Patient demographics, laboratory, and clinical data are summarized in Table 1. All patients were eligible for rapid infusion rituximab according to institutional criteria. Two grade 2 infusion reactions and 4 grade 3 reactions were reported (1 patient experienced a grade 2 and 3 reaction); however none of these patients required hospitalization. All 5 patients received pharmacological and/or supportive care to relieve the symptoms associated with the reaction. Of these 5 patients, 3 patients went on to receive rapid infusions of rituximab; 2 patients were switched to standard infusion per physician request. The sample size was too small to determine if a correlation existed between infusion related reactions and the schedule of maintenance rituximab. Conclusion: The rapid infusion of rituximab in patients receiving maintenance therapy is well tolerated with minimal incidence of infusion-related reactions. Although the sample size was insufficient to assess differences in adverse effects according to the maintenance schedule, the low overall incidence of adverse effects suggests that rapid rituximab infusions are well tolerated regardless of maintenance schedule. Our study concludes rapid infusion rituximab is a safe and feasible option for maintenance therapy. Disclosures: Ho: Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees. Off Label Use: Maintenance Rituximab Therapy in Non-Hodgkin's Lymphoma. Cultrera:Genentech: Speakers Bureau. Sotomayor:Genentech: Membership on an entity's Board of Directors or advisory committees. Wetzstein:Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Anticorpos monoclonais no tratamento oncológico: revisão de literatura para o atendimento ao paciente e manejo das reações infusionais

“…As fontes bibliográficas selecionadas foram publicadas, em sua maioria, em 2013 (23,07%) e 2015 (26,9%), seguidos por 2014 (19,2%), 2012 (19,2%), 2016 (11,5%) e 2011 (3,8%), demostrando que o tema de pesquisa é recente e pouco discutido nas áreas médicas. Em geral, os anticorpos que correspondem aos alvos dos estudos são o Obinutuzumab 3,5,[8][9][10][11][12] (26,9%), seguido pelo Rituximab 9,11,[13][14][15] (19,2%), Bevacizumab [16][17] (7,6%), Daratumumab 4,18 (7,6%), Cetuximab [19][20] (7,6%), Trastuzumab 21 (3,8%), Ipilimumab 22 (3,8%), Ocrelizumab 23 (3,8%), Brentuximab 24 (3,8%) e Ingatuzumab 25 (3,8%).…”

“…Dentre as referências bibliográficas do tema, o tipo de estudo predominante é o prospectivo (30,7%) 4,8,9,13,18,28,5 . Foram revisados, também, estudos retrospectivos (26,9%) 3,14,16,17,21 e, em menor número, os estudos de coorte (19,2%) 5,12,22,25 , relatos de caso 19,20,24 (11,5%), revisão bibliográfica 11,26 (7,6%), estudo caso-controle 23 (3,8%).…”

“…Rituximab O Rituximab é um mAb quimérico que se liga, especificamente, ao antígeno CD20 das células B (normais e em células tumorais em pacientes com linfoma não-Hodgkin de célula B e da leucemia linfocítica crônica) e ativa reações imunológicas que mediarão a lise da célula B. Os possíveis mecanismos são citotoxicidade complementodependente (CDC), citotoxicidade celular anticorpo-dependente (ADCC) e indução de apoptose 13 . Linfoma não-Hodgkin de células B, leucemia linfocítica crônica, artrite reumatoide, psoríase representam suas indicações atuais [13][14][15]28 .…”

“…Rituximab [13][14] Receptor CD20 nos Linfócitos B 32-77% calafrios, febre, náuseas, hipotensão, rash, angioedema, dispneia Estudos acerca do Obinutuzumab evidenciaram que os pacientes que receberam a primeira infusão apresentaram reação infusional com maior frequência quando comparada aos pacientes nas infusões subsequentes 4,8 . Durante a primeira administração, ocorre a liberação de citocinas pró-inflamatórias, em particular IL-6 e IL-8, as quais são acompanhadas pela redução das células natural killers.…”

“…É recomendado o início da primeira infusão de Rituximab com 50 mg/h e o acréscimo de 50 mg a cada 30 minutos com dose máxima de 400 mg/h. Se o paciente tolerar essa dosagem na primeira infusão, as infusões seguintes poderão ser iniciadas com 100 mg/h nos primeiros 15 minutos, sendo que o restante da dose poderá ser administrada nos próximos 45 minutos (protocolo de 60 minutos totais) 13,14,31 . Com base nesse protocolo, foram evidenciadas poucas ou quase nenhuma reação infusional 11,13 .…”