Incidence of Infusion-related Reaction to Monoclonal Antibody Rituximab: A National Kidney and Transplant Institute Experience

Abstract

Dear Editor, The advent of rituximab to standard therapy dramatically increased the overall survival of CD20 positive oncologic and haematologic malignancies.1 Incidence of infusionrelated reaction to rituximab is high, as high as 77% for the fi rst infusion.2 Reactions can be mild from simple rashes, to potentially life-threatening anaphylaxis. The objective of this paper is to determine the incidence of infusion reactions to rituximab, premedications used, and management given for these reactions. This is a retrospective study involving chart review of patients admitted at the National Kidney and Transplant Institute (NKTI) for rituximab administration from January 2005 to May 2011. Demographic profi le and premedications used (dexamethasone, acetaminophen, antihistamines) were obtained. Incidence of infusion reactions was determined, as well as the corresponding management. Infusion reactions were graded according to the National Cancer Institute (NCI) Criteria for Toxicity version 3. Research protocol was approved by the review board of the NKTI. Categorical variables were expressed using descriptive statistics (percentages) and continuous variables were expressed as median and range. Fisher’s Exact Test was done to determine whether there exists a difference between those with reactions and those without. Statistical analysis was carried out using SAS version 9 (SAS Institute, NC, USA). P value <0.05 was considered signifi cant. Forty-six patients were included, with a median age of 56 years (range 23 to 83). There were 22 males and 24 females, and the mean performance status was Eastern Co-operative Group (ECOG) 1 (range 0 to 3). Diffuse Large B Cell Lymphoma (DLBCL) was the most common diagnosis with 36 patients (78.27%) followed by Burkitt lymphoma and chronic lymphocytic leukemia (CLL) with 3 patients (6.52%) each. There were 5 patients who developed infusion reactions with rituximab. Infusion events occurred in 5 out of 46 patients (10.86%) during the study period. All reactions occurred in the fi rst infusion of rituximab. Three out of the 5 patients were diagnosed with DLBCL and were given R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), while the remaining 2 patients were diagnosed with CLL and were given RFC (rituximab, fl udarabine, cyclophosphamide) protocol. Four patients had grade II reaction and one patient had grade I reaction according to the NCI Toxicity criteria. All reactions occurred in the fi rst 30 minutes of infusion. Patients experienced chills, fever, and rashes. All symptoms resolved within 30 minutes. Management included infusion interruption, hydrocortisone, acetaminophen, and diphenhydramine. Rituximab rechallenge was successful, with all the patients able to complete infusion. Table 1 shows the risk profi le and premedications given to the patients. Comparing those who developed reactions to those that did not, only the use of ranitidine showed a statistical signifi cant difference (P = 0.0199).