Emily Dotson1, Brooke Crawford2, Gary Phillips3, Jeffrey Jones4. 1. The Ohio State Comprehensive Cancer Center-James Cancer Hospital, 460 W. 10th Ave., Columbus, OH, 43210, USA. Emily.Dotson@osumc.edu. 2. Richard L Roudebush VA Medical Center, Indianapolis, IN, USA. 3. The Ohio State University Center for Biostatistics, Columbus, OH, USA. 4. Department of Internal Medicine, Division of Hematology, The Ohio State Comprehensive Cancer Center-James Cancer Hospital, Columbus, OH, USA.
Abstract
PURPOSE: Rituximab is a chimeric monoclonal antibody approved to treat B cell non-Hodgkin's lymphoma (NHL). Infusion reactions among NHL patients are common during the first exposure but decrease with subsequent infusions. We sought to assess the safety and feasibility of a rituximab rapid infusion protocol in the outpatient treatment area of a comprehensive cancer center. PATIENTS AND METHODS: Patients with indolent and intermediate B cell NHL were invited to enroll in this prospective, single-institution study if they had received the first dose of rituximab according to the manufacturer-labeled standard titration schedule without grade >2 infusion reaction. The subsequent infusion proceeded without the use of steroid premedication at 100 mg/h administered over 15 min, with the remaining dose given over 45 min. Time savings between rapid infusion and standard titration were calculated. RESULTS: Fifty patients received 60-min rituximab infusions during the second drug administration. No infusion-related reactions of any grade were observed with the rapid infusion protocol (0%, one-sided 97.5% CI 0-7.1%). The mean time for the rapid rituximab infusion was 62.4 min (95% CI 61.2-63.6). When compared to the standard second dose infusion recommendation, a mean time of 94.2 min (95% 90-98.4) was saved with rapid infusion. Nursing surveys demonstrated 100% satisfaction with the rapid infusion protocol. CONCLUSIONS: Subsequent rituximab infusions can be safely administered over 60 min and without steroid premedication in an experienced outpatient infusion center when patients are appropriately screened. The faster infusions can reduce resource utilization and increase nursing satisfaction. TRIAL REGISTRATION: NCT01206777.
PURPOSE:Rituximab is a chimeric monoclonal antibody approved to treat B cell non-Hodgkin's lymphoma (NHL). Infusion reactions among NHL patients are common during the first exposure but decrease with subsequent infusions. We sought to assess the safety and feasibility of a rituximab rapid infusion protocol in the outpatient treatment area of a comprehensive cancer center. PATIENTS AND METHODS: Patients with indolent and intermediate B cell NHL were invited to enroll in this prospective, single-institution study if they had received the first dose of rituximab according to the manufacturer-labeled standard titration schedule without grade >2 infusion reaction. The subsequent infusion proceeded without the use of steroid premedication at 100 mg/h administered over 15 min, with the remaining dose given over 45 min. Time savings between rapid infusion and standard titration were calculated. RESULTS: Fifty patients received 60-min rituximab infusions during the second drug administration. No infusion-related reactions of any grade were observed with the rapid infusion protocol (0%, one-sided 97.5% CI 0-7.1%). The mean time for the rapid rituximab infusion was 62.4 min (95% CI 61.2-63.6). When compared to the standard second dose infusion recommendation, a mean time of 94.2 min (95% 90-98.4) was saved with rapid infusion. Nursing surveys demonstrated 100% satisfaction with the rapid infusion protocol. CONCLUSIONS: Subsequent rituximab infusions can be safely administered over 60 min and without steroid premedication in an experienced outpatient infusion center when patients are appropriately screened. The faster infusions can reduce resource utilization and increase nursing satisfaction. TRIAL REGISTRATION: NCT01206777.
Authors: Shaker Dakhil; Robert Hermann; Marshall T Schreeder; Stephanie A Gregory; Marc Monte; Kevin S Windsor; Deborah Hurst; Akiko Chai; Michael Brewster; Paul Richards Journal: Leuk Lymphoma Date: 2014-03-07