Abstract
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.Table 1Patient Demographicsn=105Male, n (%)55 (52.4)Median BSA (range), m21.97 (1.36-2.84)Diagnosisn (%)Follicular Lymphoma65 (62)Marginal Zone Lymphoma10 (9.5)Large B-cell lymphoma9 (8.6)Mantle Cell Lymphoma8 (7.6)CLL/SLL5 (4.8)Mucosa Associated Lymphoid Tissue3 (2.8)Other5 (4.8)Baseline Laboratory Parametersk/μL (range)Median lymphocyte count1.1 (0.04-8.21)edian WBC5.14 (1.34-13.07)RituximabMedian Dose, mg750 (510-1090)Median No. Doses5 (1-12)Mean Infusion Time, min90 (85-97) 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.
Highlights
Rituximab (Rituxan) is a chimeric IgG1 monoclonal antibody that targets the CD20 receptor and is used in the management of lymphoproliferative disorders
Rituximab is FDA approved in the treatment of chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), and rheumatoid arthritis (RA)
Patients were included if they were greater than 18 years of age, met eligibility requirements to receive rapid infusion rituximab per Moffitt protocol, and diagnosed with low-grade non-Hodgkin’s lymphoma
Summary
Rituximab (Rituxan) is a chimeric IgG1 monoclonal antibody that targets the CD20 receptor and is used in the management of lymphoproliferative disorders. Other risk factors for developing an infusion-related reaction include large tumor burden, pulmonary infiltrates, elderly patients, and individuals diagnosed with chronic lymphocytic leukemia or mantle cell lymphoma [1]. In an effort to prevent infusion-related reactions, the manufacturer recommends that the first infusion of rituximab be given at a slow initial rate and gradually titrated upward which may take up to 6 to 8 hours [2]. Studies have been conducted to determine the safety and feasibility of administering rapid rituximab; these studies did not include patients receiving rituximab maintenance for low-grade non-Hodgkin’s lymphoma [3, 6– 8]. Lee Moffitt Cancer Center with rapid infusion rituximab administered as maintenance therapy for low-grade non-Hodgkin’s lymphoma
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